Prevention of Overweight in Infancy
- Conditions
- SleepGrowthObesity
- Interventions
- Behavioral: FABBehavioral: Sleep
- Registration Number
- NCT00892983
- Lead Sponsor
- University of Otago
- 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:
1. 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.
2. 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.
3. That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
4. That intervention 2 will lead to lower rates of maternal depression and increased family well being.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 802
- Mothers booked for delivery in Dunedin, New Zealand
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Food Activity Breast feeding support FAB FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity Sleep Sleep Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months FAB + Sleep FAB combination of interventions used in arms 2 and 3 FAB + Sleep Sleep combination of interventions used in arms 2 and 3
- Primary Outcome Measures
Name Time Method BMI z score Follow-up at 11 years of age BMI z score derived from height and weight and using WHO reference data
- Secondary Outcome Measures
Name Time Method Dietary intake 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
Physical activity (PA) 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
Parental depression score Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up) Edinburgh Postnatal Depression questionnaire
Television viewing 24 months (end of intervention) and 60 months (end of follow-up) Hours of screen use by parental questionnaire
Sleep 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
Major/ Moderate sleep problems 24 months (end of intervention) Parents indicate presence of sleep problems in child
Duration of exclusive and any breast feeding 24 months Measured by repeated questionnaire
Number of night awakenings 24 months (end of intervention) and 60 months (end of follow-up) Measured by questionnaire and accelerometry at multiple timepoints
Self-regulation 42 and 60 months Measured by questionnaire and laboratory based measures at follow-up only
Body composition 60 months and 11 years (further follow-up) Measured by dual-energy x-ray absorptiometry at follow-up only
Trial Locations
- Locations (1)
University of Otago
🇳🇿Dunedin, South Island, New Zealand