Prevention of Overweight in Infancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial

Conditions
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Obesity, Growth, Sleep

Intervention / Treatment
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* Behavioral: FAB
* Behavioral: Sleep


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard well child care<br>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: Food Activity Breast feeding support<br>FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity | Behavioral: FAB<br>* 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.<br>|
| Experimental: Sleep<br>Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months | Behavioral: Sleep<br>* 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.<br>|
| Experimental: FAB + Sleep<br>combination of interventions used in arms 2 and 3 | Behavioral: FAB<br>* 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.<br>Behavioral: Sleep<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z score | BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards | 24 months (end of intervention) | 
| BMI z score | BMI z score derived from ht and weight and using WHO growth standards | 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 | Follow-up at 11 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake | Dietary information (foods, food groups, nutrients) via food frequency questionnaire | 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 | 24 months (end of intervention) and 60 months (end of follow-up) | 
| Major/ Moderate sleep problems | Parents indicate presence of sleep problems in child | 24 months (end of intervention) | 
| Physical activity (PA) | PA measured using actical accelerometry over 5-7 days | 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 | 24 months | 
| Parental depression score | Edinburgh Postnatal Depression questionnaire | 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 | 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 | 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 | 42 and 60 months | 
| Body composition | Measured by dual-energy x-ray absorptiometry at follow-up only | 60 months and 11 years (further follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Sleep, Physical activity, Breast feeding, Depression