the earn-health trial: a randomized controlled trial to · the impact of directly addressing...

For peer review only

The EARN-Health Trial: A Randomized Controlled Trial to Identify Health Effects of a Financial Savings Program

among Low-Income U.S. Adults

Journal: BMJ Open

Manuscript ID: bmjopen-2015-009366

Article Type: Protocol

Date Submitted by the Author: 10-Jul-2015

Complete List of Authors: Basu, Sanjay; Stanford University, Hamad, Rita; Stanford University, Department of Medicine White, Justin; Stanford University, Department of Medicine

Modrek, Sepideh; Stanford University, Department of Medicine Rehkopf, David; Stanford University, Department of Medicine Cullen, Mark; Stanford University, Department of Medicine

<b>Primary Subject Heading</b>:

Public health

Secondary Subject Heading: Sociology, Public health, Mental health, Health economics

Keywords: SOCIAL MEDICINE, PUBLIC HEALTH, MENTAL HEALTH, HEALTH ECONOMICS

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The EARN-Health Trial: A Randomized Controlled Trial to Identify Health Effects

of a Financial Savings Program among Low-Income U.S. Adults

Sanjay Basu1*, Rita Hamad1, Justin S. White1, Sepideh Modrek1, David H. Rehkopf1,

Mark R. Cullen1

1 Department of Medicine, Stanford University

*to whom correspondence should be addressed:

Stanford University School of Medicine

Medical School Office Building, X322

1265 Welch Road, Mail Code 5411

Stanford, CA 94305-5411

Phone: +001 (415) 881-7030

Fax: +001 (650) 725-6247

Email: [email protected]

Word count: 4,442

Keywords: poverty, debt, savings, health-related quality of life, tobacco use, alcohol use,

mental health, depression

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Abstract

Introduction

A theory within the social epidemiology field is that financial stress related to having

inadequate financial savings may contribute to psychological stress, poor mental health,

and poor health-related behaviors among low-income U.S. adults. Our objective is to test

whether an intervention that encourages financial savings among low-income U.S. adults

improves health behaviors and mental health.

Methods and analysis

A parallel group two-arm controlled superiority trial will be performed in which 700

participants will be randomized to the intervention or a wait list. The intervention arm

will be provided an online individual development account (IDA) for 6 months, during

which participants receive a $5 incentive for every month they save $20 in their account,

and an additional $5 if they save $20 for two consecutive months. Both groups will be

provided links to standard online financial counseling materials. Online surveys in

months 0 (prior to randomization), 6, and 12 (6 months post-intervention) will assess

self-reported health behaviors and mental health among participants in both arms. The

surveys items were tested previously in U.S. Centers for Disease Control and Prevention

national health interviews and related health studies, including self-reported overall

health, health-related quality of life, alcohol and tobacco use, depression symptoms,

financial stress, optimism and locus of control, and spending and savings behaviors. Trial

data will be analyzed on an intent-to-treat basis.

Ethics and dissemination

This protocol was approved by the Institutional Review Board of Stanford University

(Protocol ID: 30641). The findings of the trial will be disseminated through peer-

reviewed publication.

Trial registration

http://www.clinicaltrials.gov identifier NCT02185612

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Article Summary

Article focus

Our research study will assess whether a program designed to encourage financial

savings among low-income adults in the U.S. reduces unhealthy behaviors of tobacco

smoking and alcohol abuse as well as symptoms of poor mental health including

depression symptoms.

Key messages

Randomized trials to evaluate the health effects of financial savings programs may help

clarify whether health behaviors and outcomes that are challenging to modify through

traditional healthcare services and public health programs may be addressed by

intervening on a key hypothesized social determinant of health: financial stress.

Strengths and limitations of this study

The randomized, controlled nature of our study will assist in better elucidating the causal

pathways from financial savings to health improvement, which are not possible to infer

from observational data alone. Prior observational evidence provides little guidance on

the impact of directly addressing specific factors linking inadequate financial savings to

poor health.

The online nature of the intervention may limit its generalizability among low-income

populations.

While the intervention is focused on encouraging long-term savings, it is likely to

generate only a modest amount of savings over the short time period of the study; hence,

consistent with our hypothesized mechanism of effect, our study assesses the

psychological effects of savings behavior on health rather than the effects of increased

savings on health.

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This trial uses self-reported health metrics; future studies should incorporate objective

assessments if suggestive findings are observed in this initial study.

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Introduction

Extensive epidemiologic research has sought to understand, and identify strategies to

mitigate, the relationship between poverty and poor health [1–8]. One strain of research

on poverty and poor health has investigated the link between financial stress and

psychological stress; financial stress refers to the condition of having inadequate savings

or assets to pay for major expenses [9–14].

One proposed mechanism is that financial stress leads to desperation, anxiety, and

hopelessness, thereby worsening overall mental health and increasing the risk that

individuals will engage in substance abuse to obtain short-term stress relief, given a

fatalistic sense of their long-term quality of life [15,16]. Consistent with this theory,

recent epidemiologic studies have observed that low-income individuals in the United

States are at increased risk of manifesting depression symptoms, initiating tobacco

smoking, or binge drinking alcohol shortly after they experience financial stress

associated with having inadequate savings to pay for their expenses [17–21]. Careful

ethnographic studies among low-income U.S. adults have attributed financial stress and

associated psychological stress to not only unemployment or inadequate income, but also

to difficulties saving income—for example, due to numerous opportunities for low-

income populations to spend earned income immediately and few opportunities to save

earned income (e.g., due to predatory sales and lending institutions) [22–25]. Lack of

long-term savings is thought to contribute to financial stress, psychological stress, and

associated poor health behaviors and poor mental health even among steadily employed

low-income Americans [9,11].

Research in the field of behavioral economics has lent additional insights into

how inadequate savings may contribute to health-related decision-making. Recent

experiments suggest that when individuals have low financial savings or limited assets to

trade for money, they make more errors on cognitive performance tests and privilege

short-term over long-term goals, compared with times when those same individuals

experience high financial savings or assets [26–28]. The leading theory posed to explain

these observations is that having a limited financial “buffer” creates desperation and

focuses attention on immediate goals, to the detriment of having little mental

“bandwidth” left to make good decisions about the long term [28,29]. Hence, having

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inadequate financial savings may pose a tremendous psychological and cognitive burden,

potentially increasing the risk of making poor, short-term-focused health-related

decisions such as those related to substance abuse.

While several studies have investigated the health effects of strategies to increase

income among U.S. adults [30–38], none to our knowledge have investigated the health

effects of encouraging financial savings after income is generated. The existing literature

on the health effects of income-generating interventions in the U.S. has been surprisingly

mixed [39]. Many observational studies have investigated the health effects of tax credits

or income-generating welfare programs affecting low-income U.S. households, and

reported a wide mix of both better and worse health outcomes [32,34–36,40,41]. Several

studies have observed an increase in substance abuse, psychiatric hospitalizations, and

other adverse health outcomes following short-term increases in income among low-

income U.S. adults, contrary to the hypothesis that income generation would mitigate

poverty’s association with poor health [42–47].

An alternative hypothesis we pose to explain these mixed findings is that income

generation alone is not always sufficient to mitigate the adverse effects of poverty on

health, particularly given the factor of financial stress; we hypothesize that interventions

incentivizing the creation of a long-term plan for financial well being as income is

generated, and assisting with the saving of income to create a financial buffer against

financial stress, could help mitigate the relationship between poverty and poor health as

low-income U.S. adults generate income. To test this theory, we have planned a

randomized trial, in which we will randomize low-income U.S. adults who are earning

income to an online financial savings intervention. We will compare health behaviors and

mental health outcomes among individuals who receive the intervention, versus

participants randomized to a wait list necessitated by limited program capacity. The

savings intervention is a type of Individual Development Account, or IDA, which is a

financial intervention designed to overcome several barriers to building financial savings

among low-income U.S. adults. These barriers include financial transaction costs and

cognitive burdens associated with poverty (i.e., the ‘bandwidth’ issues described above)

that inhibit long-term planning [28,48,49]. IDAs are usually temporary savings accounts

in which low-income participants can save part of their income without fees in order to

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build personal savings and often meet a chosen goal such as paying off credit card debt,

and receive incentives to reward their savings behavior [49]. IDAs are typically run by

registered non-profit organizations, and are offered to individuals below a threshold

income level (typically 50% of county median income) [49]. While prior systematic

reviews suggest that IDA participation is associated with reduced financial stress,

increased sense of control, and increased optimism, no study has evaluated their impact

on health behaviors and mental health [49–54]. The rationale for our proposed study is to

address this evidence gap.

Our research will test the hypothesis that an IDA intervention will be superior to

standard financial education in reducing unhealthy behaviors of tobacco smoking and

alcohol abuse as well as depression symptoms. We will test this hypothesis through a

parallel group randomized trial by allocating eligible low-income adults in a 1:1 ratio to a

6-month IDA intervention and 6-month post-IDA follow-up period versus a 12-month

wait list control group receiving usual online financial counseling materials [55]. The

control arm is intended to simulate the resources that individuals in the intervention arm

would have access to in the absence of the IDA intervention. By comparing baseline, 6-

month, and 12-month surveys between the two arms, we aim to identify both immediate

post-intervention and longer-term differences between the groups in self-reported health-

related quality of life, tobacco use, alcohol use, depression symptoms, as well as

hypothesized mediators including financial stress, locus of control, and optimism.

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Methods

A parallel group two-arm controlled superiority trial will be performed.

Study setting

The study is a web-based experiment, taking place entirely through online

activities.

Eligibility criteria

Study participants must be English-speaking U.S. residents ages 18 years and

older who are below 50% of area median income defined by county of mailing address

and household size. For example, as of June 2015, 50% of area median income would be

$41,500 per year for a family of four in Los Angeles, California [56]. Participants must

have some earned income and must have filed taxes in the fiscal year prior to the study to

confirm income-based eligibility. Participants must have access to the Internet via

computer, tablet, or mobile device (e.g., smartphone); have a valid email address; have a

bank or credit union account; and have a valid Social Security Number or individual

taxpayer ID number. Participants cannot be simultaneously enrolled in another IDA

program.

Interventions

The study includes two arms:

The intervention arm will receive a 6-month IDA provided by the Earned Asset

Resource Network (EARN), a 501(c)3 non-profit organization based in San Francisco,

California. The study investigators are unaffiliated financially or personally with EARN.

EARN is among the largest providers of IDAs in the U.S., having provided IDA services

to approximately 5,200 individuals between 2002 and 2015 [57]. EARN runs a free

online service in which users who qualify for the IDA receive a 6-month personal, secure,

encrypted online IDA that links to existing bank or credit union accounts. Figure 1

depicts a hypothetical user account page. Users can electronically deposit money into the

IDA at any interval during the 6-month period. For every $20 a user deposits during a

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calendar month, EARN provides a $5 contribution into the user’s IDA as an incentive to

save. For every $20 a user deposits for two consecutive months, EARN provides an

additional $5 contribution to their IDA, to reward sustained savings habits (i.e., providing

a maximum contribution of $10 per month or $55 throughout the course of intervention).

Users are asked to define a savings goal, such as saving $300 in 6 months to pay for

educational expenses. At the end of month 6, the total savings and incentive contributions

are deposited into the user’s bank account and the intervention ends. Criteria for

discontinuing an individual’s participation are: self-reported participation in another IDA

program, early withdrawal of funds from the IDA program, or evidence of under-reported

income.

The control arm will receive notification that they are on a 12-month wait list to

participate in the IDA, and will be directed to a standard U.S. government website

designed for low-literacy readers, which provides financial counseling information about

how to save income [55]. Criteria for discontinuing an individual’s participation in the

control arm are: self-reported participation in another IDA program, or evidence of

under-reported income.

Adherence to all intervention protocols will be enhanced by automating the

process of enrollment, randomization, notification, participation, and assessment through

a streamlined set of sequentially linked webpages, as detailed below.

Outcomes

Outcomes for both arms of the trial will be assessed at months 0, 6, and 12 to

identify changes from baseline in each of the outcome variables. The outcomes will be

assessed through an online survey, which the individual will be prompted to complete

after signing the online consent form at month 0. Participants will be prompted to

complete the survey through email and telephone reminders from EARN staff; among

intervention arm participants, a reminder will also appear when participants log-in to

their online account in months 6 and 12. All participants will receive a $20 grocery store

gift card for each completed survey, distributed by postal mail to avoid interfering with

the online incentive.

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The complete survey text is provided in the Appendix. The primary outcome

variables included in the survey are self-reported health-related quality of life; physical

and mental health; tobacco and alcohol use; and depression symptoms. Self-reported

health-related quality of life and physical and mental health questions are drawn from the

U.S. Centers for Disease Control and Prevention (CDC) annual telephone-based

Behavioral Risk Factor Surveillance Study (BRFSS) [58], which asks participants to

compare their health to other people their age, and list the number of days during the past

month in which their physical or mental health was not good or kept them from

participating in usual activities. Tobacco and alcohol use questions were also adapted

from the BRFSS and include history of smoking, current smoking frequency, and quit

attempts, as well as any alcohol consumption (yes/no), number of drinks consumed

during drinking days, and number of drinking episodes meeting sex-specific criteria for

binge drinking. Depression symptoms were assessed using the Personal Health

Questionnaire Depression Scale (PHQ-8), which includes questions such as degree of

hopelessness in the past two weeks, measured on a Likert scale ranging from “not at all”

to “nearly every day.”

The secondary outcomes of the trial include the hypothesized mediators between

the IDA intervention and health, including self-reported financial stress, locus of control,

and optimism. The financial stress questions are based on prior epidemiologic studies

relating financial stress to tobacco smoking initiation and maintenance [59], and include

questions such as whether the participant has enough money saved to cover expenses for

three months without any earned income (yes/no), and what their strategy is for handling

a financial emergency (where response options include borrowing from a payday lender

or using a credit card). The locus of control and optimism questions were adapted from

the U.S. Health and Retirement Study [60], and include questions about whether

participants feel unable to solve problems in their lives, feel helpless, or feel that good

rather than bad things are more likely to happen to them; participants can respond on a 6-

point Likert scale from “strongly agree” to “strongly disagree.”

Tertiary outcomes in the survey include self-reported weight and height, as

obesity is related to poverty and indebtedness through possible stress and food access and

affordability pathways, but is not expected to change substantially during the short course

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of the trial (i.e., a negative control condition). Additional questions test whether the IDA

produces expected improvements in long-term financial outlooks, as assessed through

questions about the time-course over which the participant plans for future expenses.

Participant timeline

Table 1 provides the schedule for enrollment, intervention, and assessments

throughout the trial. The enrollment, intervention, and assessment processes are

automated through a sequence of streamlined webpages. First, interested participants

arrive on a ‘landing page’ in which they provide their first and last name, email address,

and a password. After creating this password and confirming their email address through

a hyperlink sent to their email, users provide their mailing address, demographic

information (date of birth, sex, race/ethnicity, marital status, education completed,

employment status, household size, and annual household income), and Social Security

or individual tax ID number. They also answer key qualifying information regarding

whether they have a bank account and file taxes, and they upload their 1040 tax form

from the prior tax year to verify income. Participants who do not qualify for the eligibility

criteria are informed of their denial; those who qualify next complete an informed

consent page (reproduced in the Appendix). If they consent to participate, they then

receive the month 0 survey. After the month 0 survey, they are randomized to the

intervention or control arm.

Next, intervention arm participants are shown an information page about how to

use the IDA and are asked to link to their bank account at any U.S. Federal Deposit

Insurance Corporation (FDIC)-insured bank or National Credit Union Association

(NCUA)-insured credit union through a secure, encrypted linkage system similar to that

used by employers for direct deposit transactions. Participants without a bank or credit

union account are provided a list of local bank and credit union branches and informed

that they should look for an account with no minimum balance requirements, no monthly

maintenance fees, and FDIC or NCUA insurance; they are able to return to the website

after setting up an account. Participants then see their personalized IDA home page

shown in Figure 1. The control group receives a notice that they are on a 12-month wait

list, is notified to fill out a survey every 6 months throughout the wait list period for a $20

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grocery store gift card as long as they do not participate in another IDA service, and

receives a hyperlink to standard online financial advice [55].

Participants in both arms then receive email and telephone notifications to

complete surveys in months 6 and 12. The intervention arm also receives the survey after

login. The $20 grocery store gift cards are mailed by research staff to participants in the

week following their survey completion. The intervention arm participants will close out

of the intervention and have their incentives deposited to their bank account at month 6.

Per the EARN IDA rules, participants who withdraw from the program before 6 months

only receive their savings but not their incentives, as they are notified during the

enrollment process. Both the saving and incentive earnings over 6 months are deposited

at the 6-month time point into their bank account, but not before. Following the

intervention, participants will be required to be free of any IDA participation, similar to

the control group, for an additional 6 months after completion of the month 12 survey in

order to compare longer-term outcomes between the two groups. Close-out of the study

will occur after completion of all month 12 surveys or non-response by a participant for

one month following the month 12 email and telephone notification. Participants in the

wait-listed group will be informed that they will be offered the intervention promptly

after the 12-month survey. Per EARN’s policy, participants in the intervention group will

not be allowed to re-use an EARN IDA in the future, as the intervention is a 6-month,

one-time activity for all individuals, as is typical of IDAs [49].

Sample size

As there is no prior literature estimating the impact of IDAs on the studied health

outcomes, we powered the study conservatively without a priori information to estimate

the potential effect size. Taking into account three repeated surveys per person and

assuming a typical correlation of 0.5 among the repeated measures, we would need 526

subjects distributed equally between the two arms to detect a small effect size difference

of Cohen’s f = 0.1 (for ANOVA analysis [61]) between the two groups with 80% power

at an alpha error probability of 0.05 (G*Power software version 3.1). Conservatively

assuming 25% attrition, we have aimed for a sample size of N = 700.

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We conducted further sensitivity analyses around this sample size to examine how

differences in effect size would alter power for the design; these are plotted in Figure 2.

These plots demonstrate that the necessary sample size before attrition drops to less than

250 with an effect size of f = 0.15, while at least 90% power would be achieved with our

chosen sample size and assumed attrition rate if the effect size were f = 0.12 or larger. As

also shown in Figure 2, the effect size would have to be at least f = 0.13 to have 80%

power with our chosen sample size if the correlation between repeated measures is as

high as 0.8.

Recruitment

We anticipate that recruitment will require 3 months to achieve the targeted

sample size. Our strategies to achieve adequate participant enrollment during these

months are to advertise the study at local community colleges whose enrollees share the

typical demographics of IDA users; advertise in local newspapers, radio, and online news

services; and recruit from a network of local primary care medical clinics serving low-

income populations in the greater San Francisco Bay Area. Though geographic location

is not an explicit criterion for inclusion or exclusion, many EARN users live in the San

Francisco Bay Area where EARN’s headquarters are located.

Allocation

Computer-generated random numbers will be used to generate the allocation

sequence, with no factors for stratification and no planned restrictions (e.g., blocking).

The online system will be programmed to automatically generate these numbers such that

the sequence will remain concealed until interventions are assigned automatically by the

website. To preserve blinding among all data analysts, staff at EARN will code the

survey response data such that intervention arm will be coded numerically and the

numerical key will be blinded from the research data team including all data analysts.

Unblinding will not be permitted to any data analyst during the trial. EARN staff who are

not involved in data analysis will be unblinded to ensure they can respond to email or

phone queries from participants who have questions about the logistics of using the IDA

page or need assistance entering information to link their online account to their bank

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account. These correspondences will not involve the research data analysts, and a strict

information restriction protocol will prevent EARN staff from disclosing any participant

allocation details to research staff including research data analysts throughout the trial

and post-trial analysis.

Data collection methods

Collection of demographic and survey data will be entirely online, with EARN

staff screening for duplicate accounts to prevent threats to data quality. Participants will

receive gift cards only after submission of each survey, to reduce the likelihood of

missing data or blank surveys. To promote retention and complete follow-up, EARN staff

will call participants who have not completed a survey one week after automated email

notification.

The consistency and validity of the survey measures among low-income U.S.

adults have been published previously as detailed below. For the overall self-rated health

questions, internal consistency is satisfactory (Cronbach’s alpha >0.78) and criterion

validity was moderate to high as assessed by correlations with physical health scales (rho

= 0.86, p<0.0001). Known-groups validity was also significant at an alpha level of 0.05

when comparing self-reported health between people with and without medical diagnoses

indicative of chronic disease [62]. For the tobacco and alcohol survey items, high internal

consistency has been reported (Cronbach’s alpha >0.85) [63], as well as high validity

assessed through comparison of population prevalence comparisons across surveys using

the items versus direct measurement in national surveys (<1% absolute prevalence

difference) [64–68]. The financial stress questions have satisfactory internal consistency

(alpha >0.67) [69] and are significantly associated with confirmed earnings, savings, and

expenditures [70]. The PHQ survey items are used in clinical practice as a screening

instrument for depression, having satisfactory internal consistency and high validity

(Cronbach alpha = 0.82 and goodness-of-fit index of 0.98 on confirmatory factor analysis

of emotional and somatic dimensions of depression symptoms among adults) [71]. The

optimism questions have satisfactory internal consistency (Cronbach alpha >0.78) and

significant predictive and discriminant validity for depression and coping success when

taking account effects of neuroticism, trait anxiety, self-mastery, and self-esteem in a

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sample of adults [72–74]. The locus of control questions have a satisfactory internal

consistency (Cronbach alpha >0.86) and high validity for predicting life satisfaction and

depression symptoms [75–77].

Data management

Data entry is automated from the survey website and saved on a secure, encrypted

server that meets Health Information Portability and Accountability Act (HIPAA)

standards. The survey results are coded with a participant ID rather than a name or

identifying information, and the study arm is similarly coded (1/2) to preserve blinding of

data analysts. Data analysts will check for any double data entries/duplicate surveys by

screening participant ID numbers for duplicated surveys at the same time point, keeping

only the survey responses that correspond to the later/completed survey in case an

individual experienced website reloading and survey resetting. Range checks will be

performed on all data values to ensure no errors in the survey codes. The online survey

has been tested to ensure correct capture of entered survey responses.

Statistical methods and data analysis plan

We plan an intent-to-treat analysis using mixed models to compare survey

responses between the two groups, with demographic covariates (age, sex, race/ethnicity,

and income) and individual random effects [78]. For i = 1,…, N subjects with j = 1,…,ni

repeated observations nested within each subject, we will specify a random subject

intercept and random linear time-trend model, nij = xijββββ + zijvi, where x is the vector of

regressors with coefficients ββββ, z is a vector of variables having random effects, and v are

the random effects coefficients. A link function g(·) is specified which converts the

expected value µij of the outcome variable, Y (i.e., µij = E[Yij|vi,xij]), to predictor nij. We

plan to use logit link functions for binary outcomes, ordered logit link functions for

Likert scale outcomes, and identity or log links for continuous outcome variables

depending on data skewness. Robust standard errors will be used to calculate 95%

confidence intervals, and a maximum likelihood procedure will be adopted for model

fitting. Due to the likelihood of higher dropout among the wait-listed participants,

survivorship bias will be tested by comparing baseline demographic characteristics

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between arms. Participants lost to follow-up will be censored at the time of the last

survey they completed and included in the analysis, with missing data handled using

likelihood-based pattern mixture analysis, which has been found superior in detecting and

correcting for bias as compared to the Last Observation Carried Forward method or

multiple imputation with chained equations when missingness is potentially informative

[79–82].

Data monitoring

A data monitoring committee will consist of the principal investigator (Basu), one

co-investigator (Hamad), and a member of the EARN staff. Its role is to ensure fidelity

and accurate collection of data by identifying any reasons for duplicate or erroneous

survey data responses and reporting to the overall group of investigators (co-authors of

this manuscript). The data monitoring committee is independent from the sponsor of the

trial. No interim analyses will be performed, and no trial discontinuation criteria have

been formulated as it is not anticipated that the trial would need to stop prematurely given

minimal risks to participants.

Harms

Adverse events are likely to be restricted to the risk of loss of confidentiality, and

psychological stress from completion of surveys that involve potentially sensitive health

information. To minimize potential harms, loss of confidentiality will be minimized by

using only password-protected encrypted servers for data storage, with personal

information protections detailed further below. To reduce psychological harms, the

principal investigator’s contact information is provided with the consent form, and

contact information for EARN staff is provided with surveys and on the IDA website, to

allow referral of distressed participants to area mental health services or medical

providers if needed. All adverse events will be reported to the Stanford University

Institutional Review Board.

Auditing

No specific auditing has been planned for external supervision of trial conduct.

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Research ethics approval


(Protocol ID: 30641) and by the Board of Directors of EARN.

Protocol amendments

Protocol modifications including changes to eligibility criteria, outcomes, or analyses will

be reported to the Institutional Review Board of Stanford University and posted on the

clinicaltrials.gov registry.

Consent

Informed consent will be obtained through an online web page that appears before

study enrollment, replicated in the Appendix.

Confidentiality

Personal information about potential and enrolled participants will be collected

during the enrollment process through EARN’s secure, encrypted online system. The

personal information will be held on the secure server and not shared before, during, or

after the trial. The personal information will be used to mail participants their $20 gift

card reward for survey completion, and place telephone calls and email reminders for

surveys. Subsequently, the information will be deleted. Trial data will be maintained after

the trial using only a participant ID, the study arm code, and the de-identified survey

results for months 0, 6, and 12.

Declaration of interests

No financial or other competing interests exist for the investigators in the trial.

Access to data

The study investigators listed as co-authors on this protocol will be the only

persons with direct access to the final trial dataset. Following peer-reviewed publication

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of the results, the de-identified trial data will be made accessible to third parties who sign

a data use agreement in accordance with rules set out by the National Institutes of Health,

and who agree to use the data only for non-commercial academic research purposes, not

to make attempts to identify participants, and not to distribute the data to third parties.

Ancillary and post-trial care

Ancillary and post-trial care are not deemed likely for any participants from this

study. Those participants who suffer psychological harm during the course of the study

will be referred to area medical care services.

Dissemination policy

The investigators plan to communicate trial results in a peer-reviewed publication

and potentially at academic public health conferences. No restrictions on publication

exist. Authorship will follow the International Council of Medical Journal Editors

standards for authorship, and no professional writers will be used [83]. The full protocol

will be accessible via clinicaltrials.gov. Participant-level data and statistical code will be

available upon request for non-commercial academic research purposes.

Contributorship Statement

SB wrote the first draft of the protocol. RH, JW, SM, DR, and MC contributed to revisions of the protocol.

Competing Interest

None.

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Tables and Figures

Table 1: Schedule of enrolment, interventions, and assessments. IDA: individual

development account.

TIMEPOINT

STUDY PERIOD

Enrollment Allocation Post-allocation Close-out

-t1 0 t6 t12 t12

ENROLLMENT:

Eligibility screen X

Informed consent X

Allocation X

INTERVENTIONS:

IDA X X

Wait list control X X X

ASSESSMENTS:

Online survey X X X

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Figure 1: Example of hypothetical user account webpage

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Figure 2: The study was powered to detect a conservative effect size of Cohen’s f = 0.1

with 80% power at an alpha error probability of 0.05. The sample size was calculated

assuming two study arms, three repeated surveys (months 0, 6, and 12) for each

participant, a 25% attrition rate, and a correlation of 0.5 among repeated measures. Here,

we display sensitivity analysis graphs of the pre-attrition minimum sample size needed to

detect the estimated effect size, using G*Power software (version 3.1). The graphs

display minimal sample size required under alternative effect size estimates besides f =

0.1 when (A) increasing the assumed correlation between repeated measures from 0.5 to

0.8 and (B) when attempting to achieve power of 0.9 rather than 0.8.

(A)

(B)

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Authors' contributions:

SB wrote the first draft of the protocol. RH, JW, SM, DR, and MC contributed to

revisions of the protocol.

Funding statement:

This work was supported by the National Institutes of Health through the Stanford Center

for Clinical and Translational Research and Education (SPECTRUM) under award

number UL1 TR001085. The content is solely the responsibility of the authors and does

not necessarily represent the official views of the National Institutes of Health.

Competing interests statement:

No competing interesting to declare.

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Appendix

Consent form

DESCRIPTION: You are invited to participate in a research study on how participation in the EARN.org savings account program affects your general sense of well-being, as well as symptoms of depression, anxiety, and any tobacco or alcohol use. You will be asked to take three anonymous surveys about these issues, one survey now, one in 6 months, and one in 12 months. If you only complete 1 survey, you will still receive compensation (a $20 gift card to Safeway) for that survey. You may be randomized to participate in a specific EARN.org savings account program or randomized to a 1-year wait list for that specific program. You can decide not to participate in the study and still be placed on the wait list for the program.

TIME INVOLVEMENT: Your participation will take approximately 20 minutes per survey. RISKS AND BENEFITS: The risks associated with this study are potential discomfort when you are asked about health issues. You will not receive any direct benefit from participation. We cannot and do not guarantee or promise that you will receive any benefits from this study.

PAYMENTS: You will receive a $20 gift card to Safeway as payment for your participation for each of 2 surveys. Payments may only be made to U.S. citizens, legal resident aliens, and those who have a work eligible visa. SUBJECT'S RIGHTS: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to

withdraw your consent or discontinue participation at any time without penalty or

loss of benefits to which you are otherwise entitled. The alternative is not to participate. You have the right to refuse to answer.

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Sample survey

Note that the exact fonts and formatting of the survey will appear differently online than

in this print form.

This survey helps us understand your health. It is entirely optional. The survey does not record

your name or any other information that could identify you. Your responses will be stored

anonymously on a secure computer. They will not be released to anyone outside of the study or

to the staff at Earn. The study is being conducted by the Stanford University School of Medicine.

Our goal is to better understand your health needs and how Earn services may affect your health.

This helps us to better design programs to help you stay healthy. If you have any questions,

please contact the study organizer: Sanjay Basu, (XXX) XXX-XXXX.

H0) Would you say that in general your health, as compared to other people your age, is-?

Excellent

Very good

Good

Fair

Poor

H1) Please think about your physical health. This includes physical illness and injury. How many

days during the past 30 days was your physical health not good?

H2) Now please think about your emotional health. This includes stress, depression, . How many

days during the past 30 days was your emotional health not good?

H3) During the past 30 days, for about how many days did poor physical or emotional health keep

you from doing your usual activities, such as self-care, work, or recreation?

H4) In planning your savings and spending, which of the following time periods is most important

to you and your household?

the next few months

the next year

the next few years

the next 3–5 years

longer than 5 years

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Please read the statements below and indicate the extent to which you agree with each

statement.

Strongly Disagree

Disagree

Slightly Disagree

Slightly agree

Somewhat agree

Strongly agree

O1) If something can go wrong for me it will.

O2) I’m always optimistic about my future.

O3) In uncertain times, I usually expect the best.

O4) Overall, I expect more good things to happen to me than bad.

O5) I hardly ever expect things to go my way.

O6) I rarely count on good things happening to me.

L1) I often feel helpless in dealing with the problems of life.

L2) Other people determine most of what I can and cannot do.

L3) What happens in my life is often beyond my control.

L4) I have little control over the things that happen to me.

L5) There is really no way I can solve the problems I have

L6) I can do just about anything I really set my mind to.

L7) When I really want to do something, I usually find a way to succeed at it.

L8) Whether or not I am able to get what I want is in my own hands.

L9) What happens to me in the future mostly depends on me.

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L10) I can do the things that I want to do.

A1) During the past 30 days, how many days did you have at least one drink of any alcoholic

beverage? This includes beer, wine, malt beverages, and liquor.

Days in past 30 days

A2) A drink of alcohol is 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 cocktail, or 1 shot of liquor. During the past 30 days, how many days per week or per month did you have at least one drink of any alcoholic beverage?

A3) Considering all types of alcoholic beverages, how many times during the past 30 days did

you have X [Script: X = 5 for men, X = 4 for women] or more drinks on an occasion?

H4) Are you now trying to lose weight?

yes no

H5) About how much do you weigh without shoes? Answer in pounds.

H6) About how tall are you without shoes? Answer in feet and inches.

+

Instructions: Over the last 2 weeks, how often have you been bothered by any of the following

problems?

Not at all

Several days

More than half the days

Nearly every day

M1) Little interest or pleasure in doing things

M2) Feeling down, depressed, or hopeless

M3) Trouble falling asleep or staying asleep, or sleeping too much

M4) Feeling tired or having little energy

M5) Poor appetite or overeating

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M6) Feeling bad about yourself, or that you are a failure, or have let yourself or your family down

M7) Trouble concentrating on things, such as reading the newspaper or watching television

M8) Moving or speaking so slowly that other people could have noticed. Or the opposite – being so fidgety or restless that you have been moving around a lot more than usual.

T0) Have you smoked at least 100 cigarettes in your entire life?

yes no

Script: If NO go to Part 5, else go to “T1”

T1) Do you now smoke cigarettes every day, some days, or not at all?

every day some days not at all

T2) During the past 6 months, have you stopped smoking for one day or longer because you

were trying to quit smoking?

yes no

S1) SPENDING BEHAVIORS (relative to income) Over the past six months, would you say your household has been...

Spending less money than you have had coming in.

Spending more money than you have had coming in.

Spending about the same amount of money that you have had coming in. S2) SAVINGS BEHAVIORS (regularity of savings & amount) Over the past six months, which most accurately describes your household?

We put aside money as savings every paycheck or every month.

We put aside money as savings when we can, but not regularly.

We didn't really put aside money as savings. S3) How much money did your household put aside as savings in an average month?

We did not put aside savings in an average month.

Up to $50

$51 to $100

$101 to $200

More than $200

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S4) SPENDING PLAN Does your household have a monthly spending plan?

Yes, and we mostly stick to it.

Yes, but we don't really stick to it.

No, we do not have a plan. S5)

Does your household currently have enough money saved to cover expenses for three months

without any earned income?

Yes

No

S6)

What is your household's strategy for handling a financial emergency?

I don’t have a strategy.

Borrow from payday lender

Borrow from friends or family

Borrow from another source

Use credit card

Use savings

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym _______1______

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry ________2_____

2b All items from the World Health Organization Trial Registration Data Set ______2_______

Protocol version 3 Date and version identifier ______2_______

Funding 4 Sources and types of financial, material, and other support ______29_______

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors ____1, 29_______

5b Name and contact information for the trial sponsor _____29________

5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and

interpretation of data; writing of the report; and the decision to submit the report for publication, including

whether they will have ultimate authority over any of these activities

____29_________

5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint

adjudication committee, data management team, and other individuals or groups overseeing the trial, if

applicable (see Item 21a for data monitoring committee)

_____16________

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2

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including summary of relevant

studies (published and unpublished) examining benefits and harms for each intervention

______5_______

6b Explanation for choice of comparators ______7_______

Objectives 7 Specific objectives or hypotheses ______7_______

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group),

allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

______8_______

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will

be collected. Reference to where list of study sites can be obtained

______8_______

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and

individuals who will perform the interventions (eg, surgeons, psychotherapists)

_____8________

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be

administered

______8_______

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose

change in response to harms, participant request, or improving/worsening disease)

_____9________

11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence

(eg, drug tablet return, laboratory tests)

_____9________

11d Relevant concomitant care and interventions that are permitted or prohibited during the trial ______9_______

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood

pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg,

median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen

efficacy and harm outcomes is strongly recommended

_____9-10______

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for

participants. A schematic diagram is highly recommended (see Figure)

_____11________

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3

Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including

clinical and statistical assumptions supporting any sample size calculations

_____12________

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size _____13________

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any

factors for stratification. To reduce predictability of a random sequence, details of any planned restriction

(eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants

or assign interventions

______13_______

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered,

opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned

______13_______

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to

interventions

______13_______

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome

assessors, data analysts), and how

______13_______

17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s

allocated intervention during the trial

_____13________

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related

processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.

Reference to where data collection forms can be found, if not in the protocol

______14_______

18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be

collected for participants who discontinue or deviate from intervention protocols

______14_______

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4

Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality

(eg, double data entry; range checks for data values). Reference to where details of data management

procedures can be found, if not in the protocol

________15_____

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the

statistical analysis plan can be found, if not in the protocol

_______15______

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) ______15_______

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any

statistical methods to handle missing data (eg, multiple imputation)

_______16______

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of

whether it is independent from the sponsor and competing interests; and reference to where further details

about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not

needed

______16_______

21b Description of any interim analyses and stopping guidelines, including who will have access to these interim

results and make the final decision to terminate the trial

_____16________

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse

events and other unintended effects of trial interventions or trial conduct

_____16________

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent

from investigators and the sponsor

_____16________


Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval _____17________

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes,

analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

_____17________

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5

Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and

how (see Item 32)

______17_______

26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary

studies, if applicable

______17_______

Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and maintained

in order to protect confidentiality before, during, and after the trial

______17_______

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and each study site ______17_______

Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that

limit such access for investigators

______17_______

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial

participation

_____18________

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals,

the public, and other relevant groups (eg, via publication, reporting in results databases, or other data

sharing arrangements), including any publication restrictions

_____18________

31b Authorship eligibility guidelines and any intended use of professional writers ______18_______

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code _____18________

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised surrogates ______30_______

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular

analysis in the current trial and for future use in ancillary studies, if applicable

_____N/A_______

_

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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The EARN-Health Trial: Protocol for A Randomized Controlled Trial to Identify Health Effects of a Financial

Savings Program among Low-Income U.S. Adults

Journal: BMJ Open

Manuscript ID: bmjopen-2015-009366.R1

Article Type: Protocol

Date Submitted by the Author: 19-Aug-2015

Complete List of Authors: Basu, Sanjay; Stanford University, Hamad, Rita; Stanford University, Department of Medicine White, Justin; Stanford University, Department of Medicine

Modrek, Sepideh; Stanford University, Department of Medicine Rehkopf, David; Stanford University, Department of Medicine Cullen, Mark; Stanford University, Department of Medicine

<b>Primary Subject Heading</b>:

Public health

Secondary Subject Heading: Sociology, Public health, Mental health, Health economics

Keywords: SOCIAL MEDICINE, PUBLIC HEALTH, MENTAL HEALTH, HEALTH ECONOMICS


BMJ Open on M

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Page 1 of 37

The EARN-Health Trial: Protocol for A Randomized Controlled Trial to Identify

Health Effects of a Financial Savings Program among Low-Income U.S. Adults

Sanjay Basu1*, Rita Hamad1, Justin S. White1, Sepideh Modrek1, David H. Rehkopf1,

Mark R. Cullen1

1 Department of Medicine, Stanford University

*to whom correspondence should be addressed:

Stanford University School of Medicine

Medical School Office Building, X322

1265 Welch Road, Mail Code 5411

Stanford, CA 94305-5411

Phone: +001 (415) 881-7030

Fax: +001 (650) 725-6247

Email: [email protected]

Word count: 4,442

Keywords: poverty, debt, savings, health-related quality of life, tobacco use, alcohol use,

mental health, depression

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Abstract

Introduction

A theory within the social epidemiology field is that financial stress related to having

inadequate financial savings may contribute to psychological stress, poor mental health,

and poor health-related behaviors among low-income U.S. adults. Our objective is to test

whether an intervention that encourages financial savings among low-income U.S. adults

improves health behaviors and mental health.

Methods and analysis

A parallel group two-arm controlled superiority trial will be performed in which 700

participants will be randomized to the intervention or a wait list. The intervention arm

will be provided an online individual development account (IDA) for 6 months, during

which participants receive a $5 incentive (£3.2, €4.5) for every month they save $20 in

their account (£12.8, €18), and an additional $5 if they save $20 for two consecutive

months. Both groups will be provided links to standard online financial counseling

materials. Online surveys in months 0 (prior to randomization), 6, and 12 (6 months post-

intervention) will assess self-reported health behaviors and mental health among

participants in both arms. The surveys items were tested previously in U.S. Centers for

Disease Control and Prevention national health interviews and related health studies,

including self-reported overall health, health-related quality of life, alcohol and tobacco

use, depression symptoms, financial stress, optimism and locus of control, and spending

and savings behaviors. Trial data will be analyzed on an intent-to-treat basis.



(Protocol ID: 30641). The findings of the trial will be disseminated through peer-

reviewed publication.

Trial registration

http://www.clinicaltrials.gov identifier NCT02185612

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Article Summary

Strengths and limitations of this study

• Prior observational evidence provides little guidance on the impact of directly

addressing specific factors linking inadequate financial savings to poor health.

• The randomized, controlled nature of our study will assist in better elucidating the

causal pathways from financial savings to health improvement, which are not

possible to infer from observational data alone.

• The online nature of the intervention may limit its generalizability among low-

income populations.

• Our study assesses the psychological effects of savings behavior on health

through the hypothesized mediator of financial stress; the study does not test the

effects of increased wealth or income on health, because the intervention

generates only a modest amount of savings over the short time period of the

study.

• This trial uses self-reported health metrics; future studies should incorporate

objective assessments if suggestive findings are observed in this initial study

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Introduction

Extensive epidemiologic research has sought to understand, and identify strategies to

mitigate, the relationship between poverty and poor health [1–8]. One strain of research

on poverty and poor health has investigated the link between financial stress and

psychological stress; financial stress refers to the condition of having inadequate savings

or assets to pay for major expenses [9–14].

One proposed mechanism is that financial stress leads to desperation, anxiety, and

hopelessness, thereby worsening overall mental health and increasing the risk that

individuals will engage in tobacco smoking to obtain short-term stress relief, given a

fatalistic sense of their long-term quality of life [15,16]. Consistent with this theory,

recent epidemiologic studies have observed that low-income individuals in the United

States are at increased risk of manifesting depression symptoms, initiating tobacco

smoking, or binge drinking alcohol shortly after they experience financial stress

associated with having inadequate savings to pay for their expenses [17–21]. Careful

ethnographic studies among low-income U.S. adults have attributed financial stress and

associated psychological stress to not only unemployment or inadequate income, but also

to difficulties saving income—for example, due to numerous opportunities for low-

income populations to spend earned income immediately and few opportunities to save

earned income (e.g., due to predatory sales and lending institutions) [22–25]. Lack of

long-term savings is thought to contribute to financial stress, psychological stress, and

associated poor health behaviors and poor mental health even among steadily employed

low-income Americans [9,11].

Research in the field of behavioral economics has lent additional insights into

how inadequate savings may contribute to health-related decision-making. Recent

experiments suggest that when individuals have low financial savings or limited assets to

trade for money, they make more errors on cognitive performance tests and privilege

short-term over long-term goals, compared with times when those same individuals

experience high financial savings or assets [26–28]. The leading theory posed to explain

these observations is that having a limited financial “buffer” creates desperation and

focuses attention on immediate goals, to the detriment of having little mental

“bandwidth” left to make good decisions about the long term [28,29]. Hence, having

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inadequate financial savings may pose a tremendous psychological and cognitive burden,

potentially increasing the risk of making poor, short-term-focused health-related

decisions such as those related to tobacco smoking or excessive use of alcohol.

While several studies have investigated the health effects of strategies to increase

income among U.S. adults [30–38], none to our knowledge have investigated the health

effects of encouraging financial savings after income is generated. The existing literature

on the health effects of income-generating interventions in the U.S. has been surprisingly

mixed [39]. Many observational studies have investigated the health effects of tax credits

or income-generating welfare programs affecting low-income U.S. households, and

reported a wide mix of both better and worse health outcomes [32,34–36,40,41]. Several

studies have observed an increase in drug use, psychiatric hospitalizations, and other

adverse health outcomes following short-term increases in income among low-income

U.S. adults, contrary to the hypothesis that income generation would mitigate poverty’s

association with poor health [42–47].

An alternative hypothesis we pose to explain these mixed findings is that income

generation alone is not always sufficient to mitigate the adverse effects of poverty on

health, particularly given the factor of financial stress; we hypothesize that interventions

incentivizing the creation of a long-term plan for financial well being as income is

generated, and assisting with the saving of income to create a financial buffer against

financial stress, could help mitigate the relationship between poverty and poor health as

low-income U.S. adults generate income. To test this theory, we have planned a

randomized trial, in which we will randomize low-income U.S. adults who are earning

income to an online financial savings intervention. We will compare health behaviors and

mental health outcomes among individuals who receive the intervention, versus

participants randomized to a wait list necessitated by limited program capacity. The

savings intervention is a type of Individual Development Account, or IDA, which is a

financial intervention designed to overcome several barriers to building financial savings

among low-income U.S. adults. These barriers include financial transaction costs and

cognitive burdens associated with poverty (i.e., the ‘bandwidth’ issues described above)

that inhibit long-term planning [28,48,49]. IDAs are usually temporary savings accounts

in which low-income participants can save part of their income without fees in order to

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build personal savings and often meet a chosen goal such as paying off credit card debt,

and receive incentives to reward their savings behavior [49]. IDAs are typically run by

registered non-profit organizations, and are offered to individuals below a threshold

income level (typically 50% of county median income) [49].

A small literature has explored the economic impacts of IDAs. A retrospective

uncontrolled analysis based on bank account statements from IDA participants reported

that while savings outcomes vary among participants, no commonly-collected

demographic information (such as low income or participation in public assistance

programs) was significantly predictive of success or failure of participants in IDA

programs [49]. Accompanying IDAs with support services, rather than only having a

standalone web platform for the IDA, was correlated to higher savings. A longitudinal

study using a convenience sample of IDA participants and a matched sample of non-

participants also found that participants improved their credit history and score as

compared with nonparticipants but did not track additional outcomes [50]. A similar

study that followed participants from 14 IDA programs across the United States for two

years after their program participation found that about half of participants continued to

save income after the program, and typically used their savings for home purchases,

microenterprise, or post-secondary education [51]. A subsequent controlled experiment

found similar results with regard to the outcome of homeownership, but also found that

many participants withdrew all funds prior to the completion of the IDA program and did

not continue saving when they lacked immediate incentives and/or a penalty for early

withdrawal [52]. This finding is concordant with the larger literature on financial

incentives for health behavior change. Studies of financial incentives for behavior change

have found that the most effective incentive strategies for changing health behavior

include provision of salient short-term incentives rather than only long-term benefits, and

framing of the incentives in terms of ‘loss aversion’, which means the potential to lose

future benefits [53,54,54]. A systematic review of the use of incentives for health

behavior change reported that incentivized programs are typically superior to un-

incentivized behavior change programs across a broad domain of health behaviors, from

tobacco smoking to physical activity engagement [55].

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Overall, participants in prior IDA studies reported reduced financial stress,

increased sense of control, and increased optimism, but no study to our knowledge has

evaluated the impact of the programs on health behaviors and mental health

[49,50,56,52,51,57]. The rationale for our proposed study is to address this evidence gap.

Our research will test the hypothesis that an IDA intervention will be superior to standard

financial education in reducing unhealthy behaviors of tobacco smoking and excessive

use of alcohol as well as depression symptoms. We will test this hypothesis through a

parallel group randomized trial by allocating eligible low-income adults in a 1:1 ratio to a

6-month IDA intervention and 6-month post-IDA follow-up period versus a 12-month

wait list control group receiving usual online financial counseling materials [58]. The

control arm is intended to simulate the resources that individuals in the intervention arm

would have access to in the absence of the IDA intervention. By comparing baseline, 6-

month, and 12-month surveys between the two arms, we aim to identify both immediate

post-intervention and longer-term differences between the groups in self-reported health-

related quality of life, tobacco use, alcohol use, depression symptoms, as well as

hypothesized mediators including financial stress, locus of control, and optimism.

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Methods

A parallel group two-arm controlled superiority trial will be performed.

Study setting

The study is a web-based experiment, taking place entirely through online

activities.

Eligibility criteria

Study participants must be English-speaking U.S. residents ages 18 years and

older who are below 50% of area median income defined by county of mailing address

and household size. For example, as of June 2015, 50% of area median income would be

$41,500 per year for a family of four in Los Angeles, California (£26,560, €37,350) [59].

Participants must have some earned income and must have filed taxes in the fiscal year

prior to the study to confirm income-based eligibility. Participants must have access to

the Internet via computer, tablet, or mobile device (e.g., smartphone); have a valid email

address; have a bank or credit union account; and have a valid Social Security Number or

individual taxpayer ID number. Participants cannot be simultaneously enrolled in another

IDA program.

Interventions

The study includes two arms:

The intervention arm will receive a 6-month IDA provided by the Earned Asset

Resource Network (EARN), a 501(c)3 non-profit organization based in San Francisco,

California. The study investigators are unaffiliated financially or personally with EARN.

EARN is among the largest providers of IDAs in the U.S., having provided IDA services

to approximately 5,200 individuals between 2002 and 2015 [60]. EARN runs a free

online service in which users who qualify for the IDA receive a 6-month personal, secure,

encrypted online IDA that links to existing bank or credit union accounts. Figure 1

depicts a hypothetical user account page. Users can electronically deposit money into the

IDA at any interval during the 6-month period. For every $20 a user deposits during a

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calendar month (£12.8, €18), EARN provides a $5 contribution into the user’s IDA as an

incentive to save (£3.2, €4.5). For every $20 a user deposits for two consecutive months,

EARN provides an additional $5 contribution to their IDA, to reward sustained savings

habits (i.e., providing a maximum contribution of $10 per month or $55 throughout the

course of intervention). Users are asked to define a savings goal, such as saving $300 in 6

months to pay for educational expenses (£192, €270). At the end of month 6, the total

savings and incentive contributions are deposited into the user’s bank account and the

intervention ends. Criteria for discontinuing an individual’s participation are: self-

reported participation in another IDA program, early withdrawal of funds from the IDA

program, or evidence of under-reported income.

The control arm will receive notification that they are on a 12-month wait list to

participate in the IDA, and will be directed to a standard U.S. government website

designed for low-literacy readers, which provides financial counseling information about

how to save income [58]. Criteria for discontinuing an individual’s participation in the

control arm are: self-reported participation in another IDA program, or evidence of

under-reported income.

Adherence to all intervention protocols will be enhanced by automating the

process of enrollment, randomization, notification, participation, and assessment through

a streamlined set of sequentially linked webpages, as detailed below.

Outcomes

Outcomes for both arms of the trial will be assessed at months 0, 6, and 12 to

identify changes from baseline in each of the outcome variables. The outcomes will be

assessed through an online survey, which the individual will be prompted to complete

after signing the online consent form at month 0. Participants will be prompted to

complete the survey through email and telephone reminders from EARN staff; among

intervention arm participants, a reminder will also appear when participants log-in to

their online account in months 6 and 12. All participants will receive a $20 grocery store

gift card for each completed survey (£12.8, €18), distributed by postal mail to avoid

interfering with the online incentive.

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The complete survey text is provided in the Appendix. The primary outcome

variables included in the survey are self-reported health-related quality of life; physical

and mental health; tobacco and alcohol use; and depression symptoms. Self-reported

health-related quality of life and physical and mental health questions are drawn from the

U.S. Centers for Disease Control and Prevention (CDC) annual telephone-based

Behavioral Risk Factor Surveillance Study (BRFSS) [61], which asks participants to

compare their health to other people their age, and list the number of days during the past

month in which their physical or mental health was not good or kept them from

participating in usual activities. Tobacco and alcohol use questions were also adapted

from the BRFSS and include history of smoking, current smoking frequency, and quit

attempts, as well as any alcohol consumption (yes/no), number of drinks consumed

during drinking days, and number of drinking episodes meeting sex-specific criteria for

binge drinking. Depression symptoms were assessed using the Personal Health

Questionnaire Depression Scale (PHQ-8), which includes questions such as degree of

hopelessness in the past two weeks, measured on a Likert scale ranging from “not at all”

to “nearly every day.”

The secondary outcomes of the trial include the hypothesized mediators between

the IDA intervention and health, including self-reported financial stress, locus of control,

and optimism. The financial stress questions are based on prior epidemiologic studies

relating financial stress to tobacco smoking initiation and maintenance [62], and include

questions such as whether the participant has enough money saved to cover expenses for

three months without any earned income (yes/no), and what their strategy is for handling

a financial emergency (where response options include borrowing from a payday lender

or using a credit card). The locus of control and optimism questions were adapted from

the U.S. Health and Retirement Study [63], and include questions about whether

participants feel unable to solve problems in their lives, feel helpless, or feel that good

rather than bad things are more likely to happen to them; participants can respond on a 6-

point Likert scale from “strongly agree” to “strongly disagree.”

Tertiary outcomes in the survey include self-reported weight and height, as

obesity is related to poverty and indebtedness through possible stress and food access and

affordability pathways, but is not expected to change substantially during the short course

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of the trial (i.e., a negative control condition). Additional questions test whether the IDA

produces expected improvements in long-term financial outlooks, as assessed through

questions about the time-course over which the participant plans for future expenses.

Participant timeline

Table 1 provides the schedule for enrollment, intervention, and assessments

throughout the trial. The enrollment, intervention, and assessment processes are

automated through a sequence of streamlined webpages. First, interested participants

arrive on a ‘landing page’ in which they provide their first and last name, email address,

and a password. After creating this password and confirming their email address through

a hyperlink sent to their email, users provide their mailing address, demographic

information (date of birth, sex, race/ethnicity, marital status, education completed,

employment status, household size, and annual household income), and Social Security

or individual tax ID number. They also answer key qualifying information regarding

whether they have a bank account and file taxes, and they upload their 1040 tax form

from the prior tax year to verify income. Participants who do not qualify for the eligibility

criteria are informed of their denial; those who qualify next complete an informed

consent page (reproduced in the Appendix). If they consent to participate, they then

receive the month 0 survey. After the month 0 survey, they are randomized to the

intervention or control arm.

Next, intervention arm participants are shown an information page about how to

use the IDA and are asked to link to their bank account at any U.S. Federal Deposit

Insurance Corporation (FDIC)-insured bank or National Credit Union Association

(NCUA)-insured credit union through a secure, encrypted linkage system similar to that

used by employers for direct deposit transactions. Participants without a bank or credit

union account are provided a list of local bank and credit union branches and informed

that they should look for an account with no minimum balance requirements, no monthly

maintenance fees, and FDIC or NCUA insurance; they are able to return to the website

after setting up an account. Participants then see their personalized IDA home page

shown in Figure 1. The control group receives a notice that they are on a 12-month wait

list, is notified to fill out a survey every 6 months throughout the wait list period for a $20

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grocery store gift card (£12.8, €18) as long as they do not participate in another IDA

service, and receives a hyperlink to standard online financial advice [58].

Participants in both arms then receive email and telephone notifications to

complete surveys in months 6 and 12. The intervention arm also receives the survey after

login. The $20 grocery store gift cards are mailed by research staff to participants in the

week following their survey completion. The intervention arm participants will close out

of the intervention and have their incentives deposited to their bank account at month 6.

Per the EARN IDA rules, participants who withdraw from the program before 6 months

only receive their savings but not their incentives, as they are notified during the

enrollment process. Both the saving and incentive earnings over 6 months are deposited

at the 6-month time point into their bank account, but not before. Following the

intervention, participants will be required to be free of any IDA participation, similar to

the control group, for an additional 6 months after completion of the month 12 survey in

order to compare longer-term outcomes between the two groups. Close-out of the study

will occur after completion of all month 12 surveys or non-response by a participant for

one month following the month 12 email and telephone notification. Participants in the

wait-listed group will be informed that they will be offered the intervention promptly

after the 12-month survey. Per EARN’s policy, participants in the intervention group will

not be allowed to re-use an EARN IDA in the future, as the intervention is a 6-month,

one-time activity for all individuals, as is typical of IDAs [49].

Sample size

As there is no prior literature estimating the impact of IDAs on the studied health

outcomes, we powered the study conservatively without a priori information to estimate

the potential effect size. Taking into account three repeated surveys per person and

assuming a typical correlation of 0.5 among the repeated measures, we would need 526

subjects distributed equally between the two arms to detect a small effect size difference

of Cohen’s f = 0.1 (for ANOVA analysis [64]) between the two groups with 80% power

at an alpha error probability of 0.05 (G*Power software version 3.1). Conservatively

assuming 25% attrition, we have aimed for a sample size of N = 700.

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We conducted further sensitivity analyses around this sample size to examine how

differences in effect size would alter power for the design; these are plotted in Figure 2.

These plots demonstrate that the necessary sample size before attrition drops to less than

250 with an effect size of f = 0.15, while at least 90% power would be achieved with our

chosen sample size and assumed attrition rate if the effect size were f = 0.12 or larger. As

also shown in Figure 2, the effect size would have to be at least f = 0.13 to have 80%

power with our chosen sample size if the correlation between repeated measures is as

high as 0.8.

Recruitment

We anticipate that recruitment will require 3 months to achieve the targeted

sample size. Our strategies to achieve adequate participant enrollment during these

months are to advertise the study at local community colleges whose enrollees share the

typical demographics of IDA users; advertise in local newspapers, radio, and online news

services; and recruit from a network of local primary care medical clinics serving low-

income populations in the greater San Francisco Bay Area. Though geographic location

is not an explicit criterion for inclusion or exclusion, many EARN users live in the San

Francisco Bay Area where EARN’s headquarters are located.

Allocation

Computer-generated random numbers will be used to generate the allocation

sequence, with no factors for stratification and no planned restrictions (e.g., blocking).

The online system will be programmed to automatically generate these numbers such that

the sequence will remain concealed until interventions are assigned automatically by the

website. To preserve blinding among all data analysts, staff at EARN will code the

survey response data such that intervention arm will be coded numerically and the

numerical key will be blinded from the research data team including all data analysts.

Unblinding will not be permitted to any data analyst during the trial. EARN staff who are

not involved in data analysis will be unblinded to ensure they can respond to email or

phone queries from participants who have questions about the logistics of using the IDA

page or need assistance entering information to link their online account to their bank

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account. These correspondences will not involve the research data analysts, and a strict

information restriction protocol will prevent EARN staff from disclosing any participant

allocation details to research staff including research data analysts throughout the trial

and post-trial analysis.

Data collection methods

Collection of demographic and survey data will be entirely online, with EARN

staff screening for duplicate accounts to prevent threats to data quality. Participants will

receive gift cards only after submission of each survey, to reduce the likelihood of

missing data or blank surveys. To promote retention and complete follow-up, EARN staff

will call participants who have not completed a survey one week after automated email

notification.

The consistency and validity of the survey measures among low-income U.S.

adults have been published previously as detailed below. For the overall self-rated health

questions, internal consistency is satisfactory (Cronbach’s alpha >0.78) and criterion

validity was moderate to high as assessed by correlations with physical health scales (rho

= 0.86, p<0.0001). Known-groups validity was also significant at an alpha level of 0.05

when comparing self-reported health between people with and without medical diagnoses

indicative of chronic disease [65]. For the tobacco and alcohol survey items, high internal

consistency has been reported (Cronbach’s alpha >0.85) [66], as well as high validity

assessed through comparison of population prevalence comparisons across surveys using

the items versus direct measurement in national surveys (<1% absolute prevalence

difference) [67–71]. The financial stress questions have satisfactory internal consistency

(alpha >0.67) [72] and are significantly associated with confirmed earnings, savings, and

expenditures [73]. The PHQ survey items are used in clinical practice as a screening

instrument for depression, having satisfactory internal consistency and high validity

(Cronbach alpha = 0.82 and goodness-of-fit index of 0.98 on confirmatory factor analysis

of emotional and somatic dimensions of depression symptoms among adults) [74]. The

optimism questions have satisfactory internal consistency (Cronbach alpha >0.78) and

significant predictive and discriminant validity for depression and coping success when

taking account effects of neuroticism, trait anxiety, self-mastery, and self-esteem in a

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sample of adults [75–77]. The locus of control questions have a satisfactory internal

consistency (Cronbach alpha >0.86) and high validity for predicting life satisfaction and

depression symptoms [78–80].

Data management

Data entry is automated from the survey website and saved on a secure, encrypted

server that meets Health Information Portability and Accountability Act (HIPAA)

standards. The survey results are coded with a participant ID rather than a name or

identifying information, and the study arm is similarly coded (1/2) to preserve blinding of

data analysts. Data analysts will check for any double data entries/duplicate surveys by

screening participant ID numbers for duplicated surveys at the same time point, keeping

only the survey responses that correspond to the later/completed survey in case an

individual experienced website reloading and survey resetting. Range checks will be

performed on all data values to ensure no errors in the survey codes. The online survey

has been tested to ensure correct capture of entered survey responses.

Statistical methods and data analysis plan

We plan an intent-to-treat analysis using mixed models to compare survey

responses between the two groups, with demographic covariates (age, sex, race/ethnicity,

and income) and individual random effects [81]. For i = 1,…, N subjects with j = 1,…,ni

repeated observations nested within each subject, we will specify a random subject

intercept and random linear time-trend model, nij = xijββββ + zijvi, where x is the vector of

regressors with coefficients ββββ, z is a vector of variables having random effects, and v are

the random effects coefficients. A link function g(·) is specified which converts the

expected value µij of the outcome variable, Y (i.e., µij = E[Yij|vi,xij]), to predictor nij. We

plan to use logit link functions for binary outcomes, ordered logit link functions for

Likert scale outcomes, and identity or log links for continuous outcome variables

depending on data skewness. Robust standard errors will be used to calculate 95%

confidence intervals, and a maximum likelihood procedure will be adopted for model

fitting. Due to the likelihood of higher dropout among the wait-listed participants,

survivorship bias will be tested by comparing baseline demographic characteristics

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between arms. Participants lost to follow-up will be censored at the time of the last

survey they completed and included in the analysis, with missing data handled using

likelihood-based pattern mixture analysis, which has been found superior in detecting and

correcting for bias as compared to the Last Observation Carried Forward method or

multiple imputation with chained equations when missingness is potentially informative

[82–85].

Process evaluation

To assist in interpretation of the quantitative results, participants in both trial arms

will be asked if they are willing to engage in a brief, anonymous telephone interview to

further elicit qualitative responses to the intervention for an additional $10 gift card (£6.4,

€9). Those participants who consent to participate in telephone interviews will be called

by research staff after the quantitative data analysis is complete, and answer open-ended

questions to further understand the linkages between the intervention and self-reported

health outcomes. The conversations will focus on whether the participants received the

incentives and found them to be helpful prompts to engage in savings; whether the

participants were engaging in other savings programs or any health programs that may

have affected their survey responses; how they felt about the program rules and the

duration of the intervention; whether they have suggestions for intervention refinement;

and (in the control group) whether the participants enrolled in alternative savings

programs or read the online material that was provided as an alternative to the IDA

intervention.

Data monitoring

A data monitoring committee will consist of external scientists with expertise on

financial stress and health behavior, including a chairperson (Arjumand Siddiqi,

University of North Carolina Chapel Hill/University of Toronto) and independent trial

steering committee (Aaron Reeves, University of Oxford; Mauricio Avendano-Pabon,

Harvard University/London School of Economics; Adam Coutts, London School of

Hygiene and Tropical Medicine). Its role is to monitor progress, ensure fidelity and

accurate collection of data by identifying any reasons for duplicate or erroneous survey

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data responses and reporting to the overall group of investigators (co-authors of this

manuscript), and monitoring any safety or ethics concerns that arise during the trial. The

data monitoring committee is independent from the sponsor of the trial. No interim

analyses will be performed, and no trial discontinuation criteria have been formulated as

it is not anticipated that the trial would need to stop prematurely given minimal risks to

participants.

Harms

Adverse events are likely to be restricted to the risk of loss of confidentiality, and

psychological stress from completion of surveys that involve potentially sensitive health

information. To minimize potential harms, loss of confidentiality will be minimized by

using only password-protected encrypted servers for data storage, with personal

information protections detailed further below. To reduce psychological harms, the

principal investigator’s contact information is provided with the consent form, and

contact information for EARN staff is provided with surveys and on the IDA website, to

allow referral of distressed participants to area mental health services or medical

providers if needed. All adverse events will be reported to the Stanford University

Institutional Review Board.

Auditing

No specific auditing has been planned for external supervision of trial conduct.


Research ethics approval


(Protocol ID: 30641) and by the Board of Directors of EARN.

Protocol amendments

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Protocol modifications including changes to eligibility criteria, outcomes, or analyses will

be reported to the Institutional Review Board of Stanford University and posted on the

clinicaltrials.gov registry.

Consent

Informed consent will be obtained through an online web page that appears before

study enrollment, replicated in the Appendix.

Confidentiality

Personal information about potential and enrolled participants will be collected

during the enrollment process through EARN’s secure, encrypted online system. The

personal information will be held on the secure server and not shared before, during, or

after the trial. The personal information will be used to mail participants their $20 gift

card reward for survey completion, and place telephone calls and email reminders for

surveys. Subsequently, the information will be deleted. Trial data will be maintained after

the trial using only a participant ID, the study arm code, and the de-identified survey

results for months 0, 6, and 12.

Declaration of interests

No financial or other competing interests exist for the investigators in the trial.

Access to data

The study investigators listed as co-authors on this protocol will be the only

persons with direct access to the final trial dataset. Following peer-reviewed publication

of the results, the de-identified trial data will be made accessible to third parties who sign

a data use agreement in accordance with rules set out by the National Institutes of Health,

and who agree to use the data only for non-commercial academic research purposes, not

to make attempts to identify participants, and not to distribute the data to third parties.

Ancillary and post-trial care

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Ancillary and post-trial care are not deemed likely for any participants from this

study. Those participants who suffer psychological harm during the course of the study

will be referred to area medical care services.

Dissemination policy

The investigators plan to communicate trial results in a peer-reviewed publication

and potentially at academic public health conferences. No restrictions on publication

exist. Authorship will follow the International Council of Medical Journal Editors

standards for authorship, and no professional writers will be used [86]. The full protocol

will be accessible via clinicaltrials.gov. Participant-level data and statistical code will be

available upon request for non-commercial academic research purposes.

Three additional modes of dissemination will be employed. First, we will present

the results to an annual gathering of participants in EARN IDA programs, to elicit

responses from participants for potential future IDA program refinement and additional

health pathways for potential investigation. Secondly, we will present the results to the

National Coordinating Center for Public Health Services and Systems Research, which is

a consortium of public health departments around the country who are part of a

consortium addressing social and economic determinants of health through their local

communities. Finally, we will present at the Stanford University Center on Longevity’s

annual conference on financial security, which is attended by the major financial

institutions seeking to fund philanthropic ventures that improve both financial security

and quality of life across the life-course.

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86 Editors IC of MJ, others. Uniform requirements for manuscripts submitted to

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Tables and Figures

Table 1: Schedule of enrolment, interventions, and assessments. IDA: individual

development account.

TIMEPOINT

STUDY PERIOD

Enrollment Allocation Post-allocation Close-out

-t1 0 t6 t12 t12

ENROLLMENT:

Eligibility screen X

Informed consent X

Allocation X

INTERVENTIONS:

IDA X X X X

Wait list control X X X X

ASSESSMENTS:

Online survey X X X

Process evaluation interviews X

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Figure 1: Example of hypothetical user account webpage

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Figure 2: The study was powered to detect a conservative effect size of Cohen’s f = 0.1

with 80% power at an alpha error probability of 0.05. The sample size was calculated

assuming two study arms, three repeated surveys (months 0, 6, and 12) for each

participant, a 25% attrition rate, and a correlation of 0.5 among repeated measures. Here,

we display sensitivity analysis graphs of the pre-attrition minimum sample size needed to

detect the estimated effect size, using G*Power software (version 3.1). The graphs

display minimal sample size required under alternative effect size estimates besides f =

0.1 when (A) increasing the assumed correlation between repeated measures from 0.5 to

0.8 and (B) when attempting to achieve power of 0.9 rather than 0.8.

(A)

(B)

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Authors' contributions:

SB, RH, JW, SM, DR, and MC contributed to the conception and design of the protocol.

SB wrote the first draft of the protocol. RH, JW, SM, DR, and MC revised the protocol

critically for important intellectual content. All authors gave final approval of the version

to be published and agree to be accountable for all aspects of the work.

Funding statement:

This work was supported by the National Institutes of Health through the Stanford Center

for Clinical and Translational Research and Education (SPECTRUM) under award

number UL1 TR001085. The content is solely the responsibility of the authors and does

not necessarily represent the official views of the National Institutes of Health.

Competing interests statement:

No competing interesting to declare.

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Appendix

Consent form

DESCRIPTION: You are invited to participate in a research study on how participation in the EARN.org savings account program affects your general sense of well-being, as well as symptoms of depression, anxiety, and any tobacco or alcohol use. You will be asked to take three anonymous surveys about these issues, one survey now, one in 6 months, and one in 12 months. If you only complete 1 survey, you will still receive compensation (a $20 gift card to Safeway) for that survey. You may be randomized to participate in a specific EARN.org savings account program or randomized to a 1-year wait list for that specific program. You can decide not to participate in the study and still be placed on the wait list for the program.

TIME INVOLVEMENT: Your participation will take approximately 20 minutes per survey. RISKS AND BENEFITS: The risks associated with this study are potential discomfort when you are asked about health issues. You will not receive any direct benefit from participation. We cannot and do not guarantee or promise that you will receive any benefits from this study.

PAYMENTS: You will receive a $20 gift card to Safeway as payment for your participation for each of 2 surveys. Payments may only be made to U.S. citizens, legal resident aliens, and those who have a work eligible visa. SUBJECT'S RIGHTS: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to

withdraw your consent or discontinue participation at any time without penalty or

loss of benefits to which you are otherwise entitled. The alternative is not to participate. You have the right to refuse to answer. Typing your name into the text box below will confirm your consent to participate in the study.

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Sample survey

Note that the exact fonts and formatting of the survey will appear differently online than

in this print form.

This survey helps us understand your health. It is entirely optional. The survey does not record

your name or any other information that could identify you. Your responses will be stored

anonymously on a secure computer. They will not be released to anyone outside of the study or

to the staff at Earn. The study is being conducted by the Stanford University School of Medicine.

Our goal is to better understand your health needs and how Earn services may affect your health.

This helps us to better design programs to help you stay healthy. If you have any questions,

please contact the study organizer: Sanjay Basu, (XXX) XXX-XXXX.

H0) Would you say that in general your health, as compared to other people your age, is-?

Excellent

Very good

Good

Fair

Poor

H1) Please think about your physical health. This includes physical illness and injury. How many

days during the past 30 days was your physical health not good?

H2) Now please think about your emotional health. This includes stress, depression, . How many

days during the past 30 days was your emotional health not good?

H3) During the past 30 days, for about how many days did poor physical or emotional health keep

you from doing your usual activities, such as self-care, work, or recreation?

H4) In planning your savings and spending, which of the following time periods is most important

to you and your household?

the next week

the next month

the next 2-6 months

the next year

the next 2-5 years or longer

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Please read the statements below and indicate the extent to which you agree with each

statement.

Strongly Disagree

Disagree

Slightly Disagree

Slightly agree

Somewhat agree

Strongly agree

O1) If something can go wrong for me it will.

O2) I’m always optimistic about my future.

O3) In uncertain times, I usually expect the best.

O4) Overall, I expect more good things to happen to me than bad.

O5) I hardly ever expect things to go my way.

O6) I rarely count on good things happening to me.

L1) I often feel helpless in dealing with the problems of life.

L2) Other people determine most of what I can and cannot do.

L3) What happens in my life is often beyond my control.

L4) I have little control over the things that happen to me.

L5) There is really no way I can solve the problems I have

L6) I can do just about anything I really set my mind to.

L7) When I really want to do something, I usually find a way to succeed at it.

L8) Whether or not I am able to get what I want is in my own hands.

L9) What happens to me in the future mostly depends on me.

L10) I can do the things that I want to do.

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A1) During the past 30 days, how many days did you have at least one drink of any alcoholic

beverage? This includes beer, wine, malt beverages, and liquor.

Days in past 30 days

A2) A drink of alcohol is 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 cocktail, or 1 shot of liquor. During the past 30 days, how many days per week or per month did you have at least one drink of any alcoholic beverage?

A3) Considering all types of alcoholic beverages, how many times during the past 30 days did

you have X [Script: X = 5 for men, X = 4 for women] or more drinks on an occasion?

H4) Are you now trying to lose weight?

yes no

H5) About how much do you weigh without shoes? Answer in pounds.

H6) About how tall are you without shoes? Answer in feet and inches.

+

Instructions: Over the last 2 weeks, how often have you been bothered by any of the following

problems?

Not at all

Several days

More than half the days

Nearly every day

M1) Little interest or pleasure in doing things

M2) Feeling down, depressed, or hopeless

M3) Trouble falling asleep or staying asleep, or sleeping too much

M4) Feeling tired or having little energy

M5) Poor appetite or overeating

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M6) Feeling bad about yourself, or that you are a failure, or have let yourself or your family down

M7) Trouble concentrating on things, such as reading the newspaper or watching television

M8) Moving or speaking so slowly that other people could have noticed. Or the opposite – being so fidgety or restless that you have been moving around a lot more than usual.

T0) Have you smoked at least 100 cigarettes in your entire life?

yes no

Script: If NO go to Part 5, else go to “T1”

T1) Do you now smoke cigarettes every day, some days, or not at all?

every day some days not at all

T2) During the past 6 months, have you stopped smoking for one day or longer because you

were trying to quit smoking?

yes no

S1) SPENDING BEHAVIORS (relative to income) Over the past six months, would you say your household has been...

Spending less money than you have had coming in.

Spending more money than you have had coming in.

Spending about the same amount of money that you have had coming in. S2) SAVINGS BEHAVIORS (regularity of savings & amount) Over the past six months, which most accurately describes your household?

We put aside money as savings every paycheck or every month.

We put aside money as savings when we can, but not regularly.

We didn't really put aside money as savings. S3) How much money did your household put aside as savings in an average month?

We did not put aside savings in an average month.

Up to $50

$51 to $100

$101 to $200

More than $200

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S4) SPENDING PLAN Does your household have a monthly spending plan?

Yes, and we mostly stick to it.

Yes, but we don't really stick to it.

No, we do not have a plan. S5)

Does your household currently have enough money saved to cover expenses for three months

without any earned income?

Yes

No

S6)

What is your household's strategy for handling a financial emergency?

I don’t have a strategy.

Borrow from payday lender

Borrow from friends or family

Borrow from another source

Use credit card

Use savings

S7)

Are you wiling to have a study staff member contact you for a telephone conversation about your

experiences with this study?

Yes

No

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym _______1______

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry ________2_____

2b All items from the World Health Organization Trial Registration Data Set ______2_______

Protocol version 3 Date and version identifier ______2_______

Funding 4 Sources and types of financial, material, and other support ______29_______

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors ____1, 29_______

5b Name and contact information for the trial sponsor _____29________

5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and

interpretation of data; writing of the report; and the decision to submit the report for publication, including

whether they will have ultimate authority over any of these activities

____29_________

5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint

adjudication committee, data management team, and other individuals or groups overseeing the trial, if

applicable (see Item 21a for data monitoring committee)

_____16________

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Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including summary of relevant

studies (published and unpublished) examining benefits and harms for each intervention

______5_______

6b Explanation for choice of comparators ______7_______

Objectives 7 Specific objectives or hypotheses ______7_______

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group),

allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

______8_______

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will

be collected. Reference to where list of study sites can be obtained

______8_______

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and

individuals who will perform the interventions (eg, surgeons, psychotherapists)

_____8________

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be

administered

______8_______

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose

change in response to harms, participant request, or improving/worsening disease)

_____9________

11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence

(eg, drug tablet return, laboratory tests)

_____9________

11d Relevant concomitant care and interventions that are permitted or prohibited during the trial ______9_______

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood

pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg,

median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen

efficacy and harm outcomes is strongly recommended

_____9-10______

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for

participants. A schematic diagram is highly recommended (see Figure)

_____11________

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Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including

clinical and statistical assumptions supporting any sample size calculations

_____12________

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size _____13________

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any

factors for stratification. To reduce predictability of a random sequence, details of any planned restriction

(eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants

or assign interventions

______13_______

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered,

opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned

______13_______

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to

interventions

______13_______

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome

assessors, data analysts), and how

______13_______

17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s

allocated intervention during the trial

_____13________

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related

processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.

Reference to where data collection forms can be found, if not in the protocol

______14_______

18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be

collected for participants who discontinue or deviate from intervention protocols

______14_______

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Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality

(eg, double data entry; range checks for data values). Reference to where details of data management

procedures can be found, if not in the protocol

________15_____

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the

statistical analysis plan can be found, if not in the protocol

_______15______

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) ______15_______

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any

statistical methods to handle missing data (eg, multiple imputation)

_______16______

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of

whether it is independent from the sponsor and competing interests; and reference to where further details

about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not

needed

______16_______

21b Description of any interim analyses and stopping guidelines, including who will have access to these interim

results and make the final decision to terminate the trial

_____16________

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse

events and other unintended effects of trial interventions or trial conduct

_____16________

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent

from investigators and the sponsor

_____16________


Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval _____17________

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes,

analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

_____17________

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5

Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and

how (see Item 32)

______17_______

26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary

studies, if applicable

______17_______

Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and maintained

in order to protect confidentiality before, during, and after the trial

______17_______

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and each study site ______17_______

Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that

limit such access for investigators

______17_______

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial

participation

_____18________

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals,

the public, and other relevant groups (eg, via publication, reporting in results databases, or other data

sharing arrangements), including any publication restrictions

_____18________

31b Authorship eligibility guidelines and any intended use of professional writers ______18_______

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code _____18________

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised surrogates ______30_______

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular

analysis in the current trial and for future use in ancillary studies, if applicable

_____N/A_______

_

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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the earn-health trial: a randomized controlled trial to · the impact of directly addressing...

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