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