University of Otago
Dunedin, South Island, 9013, New Zealand
NCT Number: NCT00892983
Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.
This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.
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Notify Me16 year–55 year
All sexes
Interventional
Not applicable
Dunedin, South Island, 9013, New Zealand
We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard well child care plus 7 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, and 3, 4, 7, 9, 13, and 18 months post-partum.
Standard well child care plus 2 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), and sleep problem prevention at 3 weeks. A sleep problem intervention starting at 6 months was possible for those indicating their child had a sleep problem at 6 months of age. Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months. Intervention after 6 months uses preferentially a technique called "parental presence", and if this does not fit family a technique called "camping out" and finally, if neither of the first two fit family, controlled crying.
Time frame: 24 months (end of intervention)
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
Time frame: 60 months of age (followup at 5 years of age)
BMI z score derived from ht and weight and using WHO growth standards
Time frame: Follow-up at 11 years of age
BMI z score derived from height and weight and using WHO reference data
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Dietary information (foods, food groups, nutrients) via food frequency questionnaire
Time frame: 24 months (end of intervention) and 60 months (end of follow-up)
Hours of screen use by parental questionnaire
Time frame: 24 months (end of intervention)
Parents indicate presence of sleep problems in child
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
PA measured using actical accelerometry over 5-7 days
Time frame: 24 months
Measured by repeated questionnaire
Time frame: Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
Edinburgh Postnatal Depression questionnaire
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Measured by questionnaire and accelerometry at multiple timepoints
Time frame: 24 months (end of intervention) and 60 months (end of follow-up)
Measured by questionnaire and accelerometry at multiple timepoints
Time frame: 42 and 60 months
Measured by questionnaire and laboratory based measures at follow-up only
Time frame: 60 months and 11 years (further follow-up)
Measured by dual-energy x-ray absorptiometry at follow-up only
University of Otago
Other
Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Acronym: POInz
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