Prevention of Overweight in Infancy (POInz)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Otago
ClinicalTrials.gov Identifier:
NCT00892983
First received: May 3, 2009
Last updated: August 2, 2011
Last verified: May 2011

May 3, 2009
August 2, 2011
May 2009
April 2013   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00892983 on ClinicalTrials.gov Archive Site
  • Energy and nutrient content of diet [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Amount of small screen viewing [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Major/ Moderate sleep problems [ Time Frame: 4,6,12,24 and 36 months ] [ Designated as safety issue: No ]
  • Physical activity (using actical accelerometry over 5 days) [ Time Frame: 24 and 36 months ] [ Designated as safety issue: No ]
  • Duration of exclusive and any breast feeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Parental depression score [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Duration of sleep [ Time Frame: 4,6,12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Number of night awakenings [ Time Frame: 4,6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention of Overweight in Infancy
Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Growth
  • Sleep
  • Behavioral: 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.
  • Behavioral: 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.
  • No Intervention: Standard well child care
    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: FAB (Food Activity Breast feeding support)
    8 extra parent contacts for augmented education and support around breast feeding, food and activity
    Intervention: Behavioral: FAB
  • Experimental: Sleep
    Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
    Intervention: Behavioral: Sleep
  • Experimental: FAB + Sleep
    combination of interventions used in arms 2 and 3
    Interventions:
    • Behavioral: FAB
    • Behavioral: Sleep
Taylor BJ, Heath AL, Galland BC, Gray AR, Lawrence JA, Sayers RM, Dale K, Coppell KJ, Taylor RW. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth. BMC Public Health. 2011 Dec 19;11:942. doi: 10.1186/1471-2458-11-942.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
April 2017
April 2013   (final data collection date for primary outcome measure)

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.
Both
15 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00892983
105891.01.P.NH, HRC 08/374
Yes
Professor Barry J Taylor, University of Otago
University of Otago
Not Provided
Principal Investigator: Barry J Taylor, FRACP University of Otago
Principal Investigator: Rachael Taylor, PhD University of Otago
University of Otago
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP