Overview

This trial is active, not recruiting.

Conditions obesity, growth, sleep
Treatments fab, sleep
Sponsor University of Otago
Start date May 2009
End date April 2013
Trial size 800 participants
Trial identifier NCT00892983, 105891.01.P.NH, HRC 08/374

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
Standard Well Child Care (SWCC) - 8 Core visits at 2-4 weeks, 6 weeks, 3, 5, 8-10 and 15 months, 2 and 3 years.
(Experimental)
8 extra parent contacts for augmented education and support around breast feeding, food and activity
fab
Standard well child care plus 8 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, 3-4, 6, 12, 15, 18, and 21 months post-partum.
(Experimental)
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
sleep
Standard well child care plus 5 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), sleep problem prevention starting at 3 weeks and then sleep problem intervention starting at 6 months or if problems emerge upto 2 years 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.
(Experimental)
combination of interventions used in arms 2 and 3
fab
Standard well child care plus 8 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, 3-4, 6, 12, 15, 18, and 21 months post-partum.
sleep
Standard well child care plus 5 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), sleep problem prevention starting at 3 weeks and then sleep problem intervention starting at 6 months or if problems emerge upto 2 years 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.

Primary Outcomes

Measure
Anthropometric measures - weight velocity 0 - 12 months, 12 - 24 months and 24 to 36 months as well as BMI z score and abdominal circumference at 24 and 36 months.
time frame: 1, 2 and 3 years

Secondary Outcomes

Measure
Energy and nutrient content of diet
time frame: 12, 24 and 36 months
Amount of small screen viewing
time frame: 12, 24 and 36 months
Major/ Moderate sleep problems
time frame: 4,6,12,24 and 36 months
Physical activity (using actical accelerometry over 5 days)
time frame: 24 and 36 months
Duration of exclusive and any breast feeding
time frame: 2 years
Parental depression score
time frame: 6 and 12 months
Duration of sleep
time frame: 4,6,12, 24 and 36 months
Number of night awakenings
time frame: 4,6, 12, 24 and 36 months

Eligibility Criteria

Male or female participants from 15 years up to 55 years old.

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.

Additional Information

Official title Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Principal investigator Barry J Taylor, FRACP
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 TV 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Otago.