Prevention of Overweight in Infancy
NCT00892983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802
Last updated 2020-07-08
Summary
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.
Conditions
- Obesity
- Growth
- Sleep
Interventions
- BEHAVIORAL
-
FAB
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.
- BEHAVIORAL
-
Sleep
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.
Sponsors & Collaborators
-
Health Research Council of NZ
collaborator UNKNOWN -
University of Otago
lead OTHER
Principal Investigators
-
Barry J Taylor, FRACP · University of Otago
-
Rachael Taylor, PhD · University of Otago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2016-04-30
- Completion
- 2017-04-30
Countries
- New Zealand
Study Locations
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