1 alain bertoni, md, mphjames carson, phd ruey-kang chang, md, mphjoan cook, phd laurie greco,...
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1
Alain Bertoni, MD, MPH James Carson, PhD
Ruey-Kang Chang, MD, MPH Joan Cook, PhD
Laurie Greco, PhD Kim Lebowitz, PhD
Rebecca Thurston, PhD
PULSOUnique Program for Optimal Health
among Latinas
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22004 Summer Institute on Behavior RCT Project PULSO
PULSOPrograma
Unico para
Latinas llevando hacia
Salud
Optima
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32004 Summer Institute on Behavior RCT Project PULSO
CVD is the leading cause of death among women,
including Latinas
Metabolic syndrome (MET-S) important risk factor
for CVD
MET-S most common risk factor among post-
menopausal Latinas
Behavioral interventions may be helpful in reducing
CVD risk
Background I
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42004 Summer Institute on Behavior RCT Project PULSO
MET-S: >3 of these risk factors: Glucose > 100, BP > 130/85, waist circum > 35 in,
HDL < 50, triglycerides >150
MET-S prevalence in post-menopausal
Latinas is > 50%, highest among any US
race/gender subgroup
Background II
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52004 Summer Institute on Behavior RCT Project PULSO
Background III Recommended treatment for MET-S is weight loss
and exercise (ATP III, 2001)
No RCT has evaluated whether these
recommendations, when implemented, are effective
Weight loss and exercise have improved
components of MET-S
Latina population is an ideal group to test this
treatment for reduction in MET-S
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62004 Summer Institute on Behavior RCT Project PULSO
Objective
To reduce the risk of CVD among
post-menopausal Latinas
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72004 Summer Institute on Behavior RCT Project PULSO
Primary Aim
To conduct an RCT to test hypothesis that a
behavioral lifestyle intervention reverses MET-S
among post-menopausal Latinas
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82004 Summer Institute on Behavior RCT Project PULSO
To test the efficacy of a behavioral lifestyle intervention in
reducing weight and ameliorating individual components of
MET-S
To test the impact of the intervention on increasing physical
fitness and decreasing caloric intake
To test the impact of the intervention on quality of life and
mental health functioning
To evaluate the safety of the intervention
Secondary Aims
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92004 Summer Institute on Behavior RCT Project PULSO
Research Design UCLA
U. TexasSan Antonio
U. Miami
Screening
Baseline Assessment
RandomizationN=300
Lifestyle ManagmentN=150
Enriched EducationN=150
Maintenance
4, 8 and 12 months assessment
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102004 Summer Institute on Behavior RCT Project PULSO
Inclusion Criteria Post-Menopausal Latinas (45-79 yrs) Proficient in Spanish or English Able to consent MET-S (> 3 ATP III criteria):
Waist circumference > 35 inches Blood pressure > 130/85 mmHg Triglyceride > 150 mg/dl Fasting glucose >100 mg/dl HDL <50 mg/dL
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112004 Summer Institute on Behavior RCT Project PULSO
Exclusion Criteria CVD Failed exercise stress test Using HRT within 6 month BMI < 25 or > 40 kg/m2
Medical condition that may be fatal Severe psychiatric disorder COPD BP > 160/100 mmHg, HbA1c > 9% Not transient
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122004 Summer Institute on Behavior RCT Project PULSO
Recruitment Community Advisory Board
Bilingual Latino recruitment staff from community
Community Approach Churches
Community centers
Spanish language media
Local retail
Health centers that serve Latinas
Community cultural events and health fairs
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132004 Summer Institute on Behavior RCT Project PULSO
Screening and Informed Consent
EnrichedEducation
EnrichedEducation
Telephone screen
ScreeningConsent
ScreeningConsent
LifestyleManagement
LifestyleManagement
Physical Examand Blood Test
FullConsent
FullConsent
Exercise StressTest
RandomizationRandomization
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142004 Summer Institute on Behavior RCT Project PULSO
Randomization
Permuted block design (6 & 8 cells),
stratified by site
Blinded to PULSO staff
Internet-based randomization administered
by Data Coordination Center
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152004 Summer Institute on Behavior RCT Project PULSO
Study Flow
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 4 months 4 months
Second Assessment Third Assessment Fourth Assessment
0 month 12 month8 month4 month
First Assessment
NE Visit NE Visit
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 4 months 4 months
16 weeks weekly visit
Second Assessment Third Assessment Fourth Assessment
0 month 12 month8 month4 month
First Assessment
monthly visit
Lifestyle Management
Enriched Education
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162004 Summer Institute on Behavior RCT Project PULSO
Lifestyle Management I Modeled after DPP Lifestyle Intervention
16 weekly individual sessions + Maintenance (delivered by
bilingual nurse educator)
Goals of Intervention:
Weight loss (>7% body weight)
Physical activity (>150 min/week)
Dietary modification (1200-2000 kcal/day,
< 25% kcal from fat)
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172004 Summer Institute on Behavior RCT Project PULSO
Lifestyle Management II
Sessions 1-8: Values assessment; Health education (MET-S,
physical activity, dietary modification)
Sessions 9-16: ACT approach (Acceptance strategies; Values
Clarification; Goal setting w/in context of personal values;
Problem-solving; Self-monitoring)
Maintenance Phase: Eight monthly individual or group sessions
(Reinforce progress & skills; Provide support; Address barriers to
health behavior maintenance)
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182004 Summer Institute on Behavior RCT Project PULSO
Lifestyle Management III Examples of culturally sensitive adaptations:
Provide transportation & child care
Emphasize affordable, healthy, regional and ethnic food
choices
De-emphasize cognitive focus
Emphasize personal values Tailor to individual
Enhance motivation
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192004 Summer Institute on Behavior RCT Project PULSO
PULSO Pilot Intervention
20 postmenopausal Latinas with MET-S16 Weeks Lifestyle ManagementResults:
Weight lossIncreased physical activity4/20 women no longer met criteria for MET-SIncreased QoL; Decreased anxiety & depression
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202004 Summer Institute on Behavior RCT Project PULSO
Control: Enriched Education Enhanced usual care
Trained nurse educator AHA, CDC education materials Review materials & answer questions Two one-hour sessions
Weeks 5 and 10 Session 1: Diet Session 2: Physical activity
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212004 Summer Institute on Behavior RCT Project PULSO
PULSO Staff Bilingual, diverse staff, drawn from
communities Interventionists (Nurse Educators) will
undergo central training by dietician, psychologist and cultural sensitivity training
Interventionists will deliver one treatment arm Nurse Practitioners blinded to treatment
assignment will perform assessments
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222004 Summer Institute on Behavior RCT Project PULSO
Treatment Fidelity Treatment-specific manuals developed
All sessions recorded and a random sample reviewed throughout study, coded for adherence to protocol, and feedback delivered
Coordinating center will monitor quality of data
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232004 Summer Institute on Behavior RCT Project PULSO
Measurements I
Primary Outcome: Reduction in MET-S, assessed as dichotomous outcome (Yes/No)
Requires the following measures:Fasting blood glucoseBlood pressureWaist circumferenceLipid panel (Triglycerides, HDL)
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242004 Summer Institute on Behavior RCT Project PULSO
Measurements II
Secondary Outcome: Reduction in weight and metabolic risk factors
Assessed as continuous variables:Fasting blood glucoseBlood pressureWaist circumferenceTriglycerides HDLWeight/BMI
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252004 Summer Institute on Behavior RCT Project PULSO
Measurements III
Secondary Outcome: Increased physical activity and reduced caloric intake
International Physical Activity Questionnaire, Long Version (IPAQ)*, Interview format
Exercise stress test
24-hour Food Recall (FR)*, Interview format2 weekdays and 1 weekend day in a 7-day periodDelivered by NP in person or by phone
*Versions available in English and Spanish
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262004 Summer Institute on Behavior RCT Project PULSO
Measurements IV
Secondary Outcome: Change in quality of life and mental health functioning
Quality of Life (SF-36)* Beck Depression Inventory (BDI-II)* Beck Anxiety Inventory (BAI)*
*Versions available in English and Spanish
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272004 Summer Institute on Behavior RCT Project PULSO
Assessment Schedule
Baseline 4 Months 8 Months 12 Months
MET-S X X X X
BMI X X X X
IPAQ X X X X
Stress Test X X X
Food Recall X X X X
SF-36 X X X X
BDI-II X X X XBAI X X X X
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282004 Summer Institute on Behavior RCT Project PULSO
Data Analysis: Primary Outcome
Intent to treat principle
Chi square test - Difference in proportion of MET-S
between groups at 12 months
Logistic regression model - Treatment impact on
MET-S controlling for study site and age at 12
months
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292004 Summer Institute on Behavior RCT Project PULSO
Data Analysis: Secondary Outcomes
Mixed model – Adjusting for baseline value, test
impact of treatment on repeated follow-up
measurements: MET-S score, WC, HDL, TG,
glucose, BP, IPAQ, SF-36, BAI, BDI, 24FR,
Peak VO2
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302004 Summer Institute on Behavior RCT Project PULSO
Power Calculation Alpha < 0.05, two sided test Power 90% Expected proportion of MET-S in Enriched
Education at study end: 95% Expected proportion of MET-S in Lifestyle
Management at study end: 80% Total number of subjects needed = 228 Expected attrition: 20% Total Sample = 300
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312004 Summer Institute on Behavior RCT Project PULSO
Power Calculation Sensitivity Analysis
Power
% MET-S*
80% 85% 90% 95%
75% 116 130 150 180
80% 176 198 228 272
85% 318 358 414 502
90% 948 1072 1240 1516
* % of participants in the Lifestyle Management Group at 12 months
Power
% MET-S*
80% 85% 90% 95%
75% 116 130 150 180
80% 176 198 228 272
85% 318 358 414 502
90% 948 1072 1240 1516
Power
% MET-S*
80% 85% 90% 95%
75% 116 130 150 180
80% 176 198 228 272
85% 318 358 414 502
90% 948 1072 1240 1516
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322004 Summer Institute on Behavior RCT Project PULSO
Data and Safety Monitoring Board
Psychologist, cardiologist, nutritionist, bioethicist
and biostatistician independent of study
Meet every 6 months, PI will submit reports to
the Board 2 weeks prior to the meeting
All adverse events will be reported according to
NIH guidelines
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332004 Summer Institute on Behavior RCT Project PULSO
Project Tasks and Timeline
Year 1 Year 2 Year 3 Year 4 Year 5
Training PersonnelTraining Personnel
Intervention and AssessmentIntervention and Assessment
DevelopingMaterial
DevelopingMaterial
Subject Recruitment and ScreeningSubject Recruitment and Screening
Data Analysis &Reporting
Data Analysis &Reporting
First Subject Enters Last Subject EntersLast Subject Completes
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342004 Summer Institute on Behavior RCT Project PULSO
Budget
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362004 Summer Institute on Behavior RCT Project PULSO
Special Thanks to….
Carlos Mendes De Leon, PhD
Bill Chapman, PhD
Nina Schooler, PhD
Karina Davidson, PhD