Skip to content

Prevention of Overweight in Infancy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00892983
Acronym
POInz
Enrollment
802
Registered
2009-05-05
Start date
2009-05-31
Completion date
2017-04-30
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Obesity, Sleep

Keywords

Obesity, Sleep, Physical activity, Breast feeding, Depression

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.

Interventions

BEHAVIORALFAB

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.

BEHAVIORALSleep

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.

Sponsors

Health Research Council of NZ
CollaboratorUNKNOWN
University of Otago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
BMI z score24 months (end of intervention)BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards

Secondary

MeasureTime frameDescription
Television viewing24 months (end of intervention) and 60 months (end of follow-up)Hours of screen use by parental questionnaire
Major/ Moderate sleep problems24 months (end of intervention)Parents indicate presence of sleep problems in child
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
Duration of exclusive and any breast feeding24 monthsMeasured by repeated questionnaire
Dietary intake24 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
Sleep24 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
Number of night awakenings24 months (end of intervention) and 60 months (end of follow-up)Measured by questionnaire and accelerometry at multiple timepoints
Self-regulation42 and 60 monthsMeasured by questionnaire and laboratory based measures at follow-up only
Body composition60 months and 11 years (further follow-up)Measured by dual-energy x-ray absorptiometry at follow-up only
Parental depression scoreMeasured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)Edinburgh Postnatal Depression questionnaire

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026