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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
802
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.
University of Otago
Dunedin, South Island, New Zealand
BMI z score
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
Time frame: 24 months (end of intervention)
BMI z score
BMI z score derived from ht and weight and using WHO growth standards
Time frame: 60 months of age (followup at 5 years of age)
BMI z score
BMI z score derived from height and weight and using WHO reference data
Time frame: Follow-up at 11 years of age
Dietary intake
Dietary information (foods, food groups, nutrients) via food frequency questionnaire
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Television viewing
Hours of screen use by parental questionnaire
Time frame: 24 months (end of intervention) and 60 months (end of follow-up)
Major/ Moderate sleep problems
Parents indicate presence of sleep problems in child
Time frame: 24 months (end of intervention)
Physical activity (PA)
PA measured using actical accelerometry over 5-7 days
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Duration of exclusive and any breast feeding
Measured by repeated questionnaire
Time frame: 24 months
Parental depression score
Edinburgh Postnatal Depression questionnaire
Time frame: Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
Sleep
Measured by questionnaire and accelerometry at multiple timepoints
Time frame: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Number of night awakenings
Measured by questionnaire and accelerometry at multiple timepoints
Time frame: 24 months (end of intervention) and 60 months (end of follow-up)
Self-regulation
Measured by questionnaire and laboratory based measures at follow-up only
Time frame: 42 and 60 months
Body composition
Measured by dual-energy x-ray absorptiometry at follow-up only
Time frame: 60 months and 11 years (further follow-up)
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