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Completed

NCT Number: NCT00892983

Prevention of Overweight in Infancy

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.

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Key information

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Otago

Dunedin, South Island, 9013, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAB

Behavioral

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.

sleep

Behavioral

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.

Primary outcomes

  1. BMI z score

    Time frame: 24 months (end of intervention)

    BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards

  2. BMI z score

    Time frame: 60 months of age (followup at 5 years of age)

    BMI z score derived from ht and weight and using WHO growth standards

  3. BMI z score

    Time frame: Follow-up at 11 years of age

    BMI z score derived from height and weight and using WHO reference data

Secondary outcomes

  1. Dietary intake

    Time frame: 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

  2. Television viewing

    Time frame: 24 months (end of intervention) and 60 months (end of follow-up)

    Hours of screen use by parental questionnaire

  3. Major/ Moderate sleep problems

    Time frame: 24 months (end of intervention)

    Parents indicate presence of sleep problems in child

  4. Physical activity (PA)

    Time frame: 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

  5. Duration of exclusive and any breast feeding

    Time frame: 24 months

    Measured by repeated questionnaire

  6. Parental depression score

    Time frame: Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)

    Edinburgh Postnatal Depression questionnaire

  7. Sleep

    Time frame: 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

  8. Number of night awakenings

    Time frame: 24 months (end of intervention) and 60 months (end of follow-up)

    Measured by questionnaire and accelerometry at multiple timepoints

  9. Self-regulation

    Time frame: 42 and 60 months

    Measured by questionnaire and laboratory based measures at follow-up only

  10. Body composition

    Time frame: 60 months and 11 years (further follow-up)

    Measured by dual-energy x-ray absorptiometry at follow-up only

Sponsors and collaborators

Lead sponsor

University of Otago

Other

Collaborators

  • Health Research Council of NZ

Registry information

Official study title

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

Acronym: POInz

Important dates

Study start
2009
Primary completion
2016
Study completion
2017
First posted
May 5, 2009
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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