Preventing Childhood Obesity Starting Early: The Baby Milk Trial Raj Lakshman

1. Preventing Childhood Obesity Starting Early: The Baby Milk Trial Raj Lakshman MRC Epidemiology Unit 24th January 2012

2. Outline Infant feeding in obesity prevention The Baby Milk Trial Rationale Development Design Outcomes Policy implications

3. 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?

4. 6 kg in 1st year

5. Distance between 2 lines 0.67SDS

6. 2 fold higher risk Druet et al 2011 Paediatric and Perinatal Epidemiology

8. Fat mass at 17yrs Crossing 1 centile line (0.67 SDS) from 0-6 mo Ekelund et al 2006 AJCN Leunissen et al 2009 JAMA

9. 40% in first weeks FAO/WHO/UNU 2005, SACN 2011

10. FAO/WHO/UNU 2005

11. Weight SDS Age in years Ong et al 2002 Paediatric Research

12. Breast feeding statistics (UK) 81% start BUT by 6 weeks only 21% exclusively breastfeeding

13. How we designed the intervention and evaluation • Determinants • Systematic Reviews • Qualitative studies • Questionnaires • Multi-disciplinary team Campbell et al 2007 BMJ Framework for complex interventions

14. JADA 2010 • 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

15. 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

17. 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.’

18. IJBNPA 2011 • 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

19. What is the Baby Milk intervention? Optimise energy intake Infant satiety cues Non-hunger related fussiness Feedback on growth Rapid weight gain Weaning

20. The components of the Baby Milk intervention Action Planning Motivation Techniques Techniques Coping Planning Techniques Communication skills 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

21. 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

22. 700 Mothers who start formula feeds within 14 weeks of birth Baseline visit at 2-14weeks 2 mo 2 mo Intervention group Control group 3 mo 3 mo 4 mo Behavioural intervention Standard advice 4 mo 5 mo 5 mo Baby’s age 6-7 months-End of intervention 6 mo 6 mo Baby’s age 8 months- 4 Day-Diet Diary Baby’s age 12 months-Outcome measurements

23. Evaluation: Causal modelling Behavioural Determinants 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 Behaviour Socio-economic, cultural, antenatal and genetic factors Anthropometry at baseline, 6 and 12 months, USS and skin-folds at 12 months Growth Modelling long term outcomes, cost-effectiveness analyses, long term follow-up Health/Disease Outcomes

24. Study Measures I- Intervention, C- Control group

25. 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’

26. Thank You CEDAR support Rebecca Strafford Research Manager, CEDAR Annie Schiff Study Co-ordinator, CEDAR Alvaro Ullrich Data Manager, CEDAR Intervention Facilitators Paediatric Research Nurses, University of Cambridge MRC Epidemiology Unit support James Sylvester Research Manager, MRC Measurement Team Research Assistants, MRC Investigators Ken Ong Programme Leader, MRC Simon Griffin Assistant Director, MRC Wendy Hardeman Senior Research Associate, IPH Simon Cohn Senior Lecturer, IPH Marc Suhrcke Prof Health Economics, UEA Ed Wilson Lecturer Health Economics, UEA Collaborators David Vickers Medical Director, CCS NHS Trust Alison Lennox Principal Investigator Scientist, MRC HNR

27. 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.