preventing childhood obesity starting early: the baby milk trial raj lakshman mrc epidemiology unit...
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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.