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Prevention of Overweight in Infancy (POInz)

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ClinicalTrials.gov Identifier: NCT00892983
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Health Research Council of NZ
Information provided by (Responsible Party):
Barry Taylor, University of Otago

May 3, 2009
May 5, 2009
February 16, 2018
May 2009
April 2016   (Final data collection date for primary outcome measure)
  • 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
  • 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
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 ]
Complete list of historical versions of study NCT00892983 on ClinicalTrials.gov Archive Site
  • Dietary intake [ Time Frame: 24 months (end of intervention) and 60 months (end of follow-up) ]
    Dietary information (foods, food groups, nutrients) via food frequency questionnaire
  • Television viewing [ Time Frame: 24 months (end of intervention) and 60 months (end of follow-up) ]
    Hours of screen use by parental questionnaire
  • Major/ Moderate sleep problems [ Time Frame: 24 months (end of intervention) ]
    Parents indicate presence of sleep problems in child
  • Physical activity (PA) [ Time Frame: 24 months (end of intervention) and 60 months (end of follow-up) ]
    PA measured using actical accelerometry over 5 days
  • Duration of exclusive and any breast feeding [ Time Frame: 24 months ]
    Measured by repeated questionnaire
  • 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
  • Sleep [ Time Frame: 24 months (end of intervention) and 60 months (end of follow-up) ]
    Measured by questionnaire and accelerometry at multiple timepoints
  • 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
  • Self-regulation [ Time Frame: 42 and 60 months ]
    Measured by questionnaire and laboratory based measures at follow-up only
  • Body composition [ Time Frame: 60 months ]
    Measured by dual-energy x-ray absorptiometry at follow-up only
  • Energy and nutrient content of diet [ Time Frame: 12, 24 and 36 months ]
  • Amount of small screen viewing [ Time Frame: 12, 24 and 36 months ]
  • Major/ Moderate sleep problems [ Time Frame: 4,6,12,24 and 36 months ]
  • Physical activity (using actical accelerometry over 5 days) [ Time Frame: 24 and 36 months ]
  • Duration of exclusive and any breast feeding [ Time Frame: 2 years ]
  • Parental depression score [ Time Frame: 6 and 12 months ]
  • Duration of sleep [ Time Frame: 4,6,12, 24 and 36 months ]
  • Number of night awakenings [ Time Frame: 4,6, 12, 24 and 36 months ]
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.

This is a two-year intervention with 3-year follow-up.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Growth
  • Sleep
  • Behavioral: FAB
    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.
  • Behavioral: Sleep
    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.
  • 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: Food Activity Breast feeding support
    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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
802
800
April 2017
April 2016   (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.
Sexes Eligible for Study: All
16 Years to 55 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
 
NCT00892983
105891.01.P.NH
HRC 08/374 ( Other Grant/Funding Number: NZ Health Research Council )
Yes
Not Provided
Not Provided
Barry Taylor, University of Otago
University of Otago
Health Research Council of NZ
Principal Investigator: Barry J Taylor, FRACP University of Otago
Principal Investigator: Rachael Taylor, PhD University of Otago
University of Otago
February 2018

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