establishing a healthy growth trajectory from birth the baby milk trial 14 th february 2011...

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Establishing a healthy growth Establishing a healthy growth trajectory from birth trajectory from birth The Baby Milk Trial 14 th February 2011 Institute of Public Health, Cambridge

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Establishing a healthy growth trajectory Establishing a healthy growth trajectory

from birthfrom birth

The Baby Milk Trial

14th February 2011

Institute of Public Health, Cambridge

• Over 1 in 5 children in England are already overweight (13%) or obese (10%) when they start school

• Early intervention is a National priority

• Evidence of ‘programming effect’

- Appetite

- Metabolic

Why intervene early?

Why intervene early?

• Infancy is a period of rapid growth, hence obesity prevention may be most effective

• Recent systematic reviews have shown that rapid weight gain during infancy is associated with later obesity

Ong Acta Paediatrica 2006

• Energy deposition as %TER-40% at 1 month, 1-2% at 1yr WHO/FAO/UNU Report

Why intervene early?

• Rapid weight gain in infancy predicts fat mass in young adults Ekelund U et al 2006 AJCN

• Rapid (>0.67 SDS) weight gain in the first 3 months associated with several determinants of CVD and type 2 diabetes in adults Leunissen R et al 2009 JAMA

• Childhood BMI is related to CHD in adulthood Baker J el al 2007 NEJM

Why the Baby Milk intervention?

• 1985 recommendations based on ‘energy intake’ using ‘indirect calorimetry’

• 2001 recommendations based on ‘energy expenditure’ using ‘doubly labelled water’

• Previous recommendations overestimated energy requirements by 15-20%

• Formula fed babies likely to be overfed

What are the components of the Baby Milk intervention?

What is the Baby Milk Trial?

• Explanatory RCT to examine the feasibility, acceptability and efficacy of the Baby Milk intervention

- Prevent excess weight gain

during infancy

- Reduce formula milk intake

• Understand the underlying psychological mediators

Trial Design

Intervention group• 3 face-to-face contacts• 2 telephone contacts

Control group• Same number of contacts

Primary outcome• Difference in weight sds• % rapid weight gain

Measurements

Behavioural Determinants

Behaviour

Growth

Health/disease outcomes

Attitudes, beliefs, intentions, self-efficacy, outcome-expectancy- Questionnaires at baseline and 6-months

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

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

Link to National Child Measurement Programme, modelling long term outcomes, cost-effectiveness

analyses, long term follow-up, Soci

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The Baby Milk Team and collaborators

The ScientistsRaj Lakshman-MRC HSHP Fellowship Ken Ong-Programme Leader, MRCSimon Griffin-Assistant Director, MRCWendy Hardeman-Senior Research Associate,

PHPCSimon Cohn–Senior Lecturer, IPH Marc Suhrcke-Prof Health Economics, UEAEd Wilson-Lecturer Health Economics, UEA

Intervention FacilitatorsAnne-Marie WardellKaren ForbesSuzanne SmithWith help from

Annie Schiff Wendy Hardeman

Measurement TeamEsther FakeyeRichard PowellRuth WatsonWith help from

Ema De Lucia Rolfe

Study ManagementAnnie SchiffAlvaro UllrichWith help from

James SylvesterNick BarkerAnthony Wright

Any questions?

Thank you for your time