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
  Purpose

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.


Condition Intervention
Obesity
Growth
Sleep
Behavioral: FAB
Behavioral: Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Otago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
Study Start Date: May 2009
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Experimental: Sleep
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
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.
Experimental: FAB + Sleep
combination of interventions used in arms 2 and 3
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.

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 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.
  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892983

Locations
New Zealand
University of Otago
Dunedin, South Island, New Zealand, 9013
Sponsors and Collaborators
University of Otago
Investigators
Principal Investigator: Barry J Taylor, FRACP University of Otago
Principal Investigator: Rachael Taylor, PhD University of Otago
  More Information

Additional Information:
No publications provided by University of Otago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Barry J Taylor, University of Otago
ClinicalTrials.gov Identifier: NCT00892983     History of Changes
Other Study ID Numbers: 105891.01.P.NH, HRC 08/374
Study First Received: May 3, 2009
Last Updated: August 2, 2011
Health Authority: New Zealand: Health Research Council

Keywords provided by University of Otago:
Obesity
Sleep
Physical activity
Breast feeding
Depression

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014