Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Otago
- Enrollment
- 802
- Locations
- 2
- Primary Endpoint
- BMI z score
Study Overview
Brief 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.
Detailed Description
We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:
- That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood.
- That anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain.
- That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
- That intervention 2 will lead to lower rates of maternal depression and increased family well being.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mothers booked for delivery in Dunedin, New Zealand
Exclusion Criteria
- •Women booked after 34 weeks gestation,
- •Identified congenital abnormality likely to affect feeding and/or growth
- •Home address outside of metropolitan Dunedin or Invercargill,
- •Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
- •Unable to communicate in English or te reo Maori.
Outcomes
Primary Outcomes
BMI z score
Time Frame: Follow-up at 11 years of age
BMI z score derived from height and weight and using WHO reference data
Secondary Outcomes
- Dietary intake(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Physical activity (PA)(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Parental depression score(Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up))
- Television viewing(24 months (end of intervention) and 60 months (end of follow-up))
- Sleep(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Major/ Moderate sleep problems(24 months (end of intervention))
- Duration of exclusive and any breast feeding(24 months)
- Number of night awakenings(24 months (end of intervention) and 60 months (end of follow-up))
- Self-regulation(42 and 60 months)
- Body composition(60 months and 11 years (further follow-up))
Investigators
Barry Taylor
Professor
University of Otago