Preventing Childhood Obesity

Starting Early: The Baby Milk Trial

Raj LakshmanMRC Epidemiology Unit24th January 2012

Outline

• Infant feeding in obesity prevention

• The Baby Milk Trial

- Rationale

- Development

- Design

- Outcomes

- Policy implications

• Over 1 in 5 children overweight (13%) or obese (10%) NCMP 2009/10

• Early intervention is a National priority Foresight, HWHL

• Evidence of programming

- Appetite

- Flavour

- Metabolic

Why infant feeding is important?

6 kg in 1st year

Distance between 2 lines 0.67SDS

Druet et al 2011 Paediatric and Perinatal Epidemiology

2 fold higher risk

Ekelund et al 2006 AJCNLeunissen et al 2009 JAMA

Crossing 1 centile line (0.67 SDS) from 0-6 mo

Fat

mass

at

17

yrs

FAO/WHO/UNU 2005, SACN 2011

40% in first weeks

FAO/WHO/UNU 2005

Ong et al 2002 Paediatric Research

Age in years

Weig

ht

SD

S

Breast feeding statistics (UK)

81% start BUTby 6 weeks only 21% exclusively breastfeeding

How we designed the intervention and evaluation

Campbell et al 2007 BMJ Framework for complex interventions

• Determinants

• Systematic Reviews

• Qualitative studies

• Questionnaires

• Multi-disciplinary team

• Aim: to understand determinants of non-recommended feeding practices

• 78 studies, 48 determinants

• Early Weaning- young maternal age, low education, low SES, smoking, short breastfeeding, lack of information and advice from Healthcare providers

JADA 2010

• Aim: how parents decide on how much and how often to feed their babies?

• 23 studies• No literature on this

• Inadequate information and support• Negative emotions- guilt, worry, sense of failure• Mistakes in feed preparation• Frequent formula-feed changes

In Press: Lakshman R, Landsbaugh J, Schiff A, Cohn C, Griffin S, Ong KK

• Interviews, Focus groups• Mothers, Healthcare providers

• ‘I had no advice on bottle feeding and he was crying so much that I was feeding him every ten minutes…..’

• ‘He drank for six and a half hours and he was swallowing for six and a half hours. He would drink about two and a half bottles. …..sometimes he’d have nine bottles a day.’

• 57-item questionnaire• Energy intake• Maternal attitudes• Face validity, Criterion validity, Test-retest reliability

• Almost half the mothers who prepared formula-milk from powder, tightly packed the scoops

IJBNPA 2011

What is the Baby Milk intervention?

• Optimise energy intake

• Infant satiety cues

• Non-hunger related fussiness

• Feedback on growth

• Rapid weight gain

• Weaning

The components of the Baby Milk intervention

Coping Planning

Motivation

ActionPlanning

Communication skills

TechniquesTechniques

Techniques

I intend to follow the Baby Milk Feeding Guidelines

This is how I plan to put the Baby Milk Feeding Guidelines into action

This is how I will stick to the Baby Milk Feeding Guidelines when the going gets tough

Baby Milk Trial

• Explanatory RCT to examine efficacy of the Baby Milk intervention

• Primary Outcome change in weight sds from birth-1yr

• Trial and cohort analyses

700 Mothers who start formula feeds within 14 weeks of birth

Baseline visit at 2-14weeks

Intervention group

Baby’s age 6-7 months-End of intervention

Baby’s age 8 months- 4 Day-Diet Diary

Baby’s age 12 months-Outcome measurements

Control group

Behavioural intervention Standard advice

2 mo

3 mo

4 mo

5 mo

6 mo

5 mo

4 mo

3 mo

2 mo

6 mo

Behavioural Determinants

Behaviour

Growth

Health/Disease Outcomes

Modelling long term outcomes, cost-effectiveness analyses, long term follow-up

Anthropometry at baseline, 6 and 12 months, USS and skin-folds at 12 months

Milk feeding – questionnaire at baseline, 3,4, 5, 6 months, Diet diary at 8 months

Attitudes, beliefs, intentions, self-efficacy, outcome-expectancy- Questionnaires at

baseline and 6-months

Soci

o-ec

onom

ic, c

ultu

ral,

ante

nata

l and

ge

netic

fac

tors

Evaluation: Causal modelling

Baseline

Questionnaire measures

Pregnancy, Demography, Lifestyle etc I,C

Milk feeds (also at 3,4,5 mo) I,C

Feeding and maternal attitudes I,C

Temperament, sleep, eating behaviour I,C

4-day diet diary

Health service utilisation

Maternal QoL I,C

Intervention evaluation

Anthropometry

Parents’ anthropometry I,C

Baby’s anthropometry I,C

6 mo

I,C

I,C

I,C

I,C

I,C

I

I,C

I,C

8 mo

I,C

12 mo

I,C

I,C

I

I,C

I,C

Study Measures

I- Intervention, C- Control group

Policy implications

• Inform future infant feeding guidelines

• Health Visitor practice and Healthy Child Programme

• NPRI Scientific Committee

‘A powerful intervention that has potential to provide valuable evidence in an important and changing policy environment’

Thank You

CEDAR support Rebecca Strafford Research Manager, CEDARAnnie Schiff Study Co-ordinator, CEDARAlvaro Ullrich Data Manager, CEDARIntervention Facilitators Paediatric Research Nurses, University of Cambridge

MRC Epidemiology Unit supportJames Sylvester Research Manager, MRCMeasurement Team Research Assistants, MRC

Investigators Ken Ong Programme Leader, MRCSimon Griffin Assistant Director, MRCWendy Hardeman Senior Research Associate, IPHSimon Cohn Senior Lecturer, IPH Marc Suhrcke Prof Health Economics, UEAEd Wilson Lecturer Health Economics, UEA

CollaboratorsDavid Vickers Medical Director, CCS NHS TrustAlison LennoxPrincipal Investigator Scientist, MRC HNR

ACKNOWLEDGEMENT

This work was undertaken by the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence.

Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged.