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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

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 3-year follow-up.


Condition or disease Intervention/treatment Phase
Obesity Growth Sleep Behavioral: FAB Behavioral: Sleep Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Study Start Date : May 2009
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2017

Arm Intervention/treatment
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
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.

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 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.

Experimental: FAB + Sleep
combination of interventions used in arms 2 and 3
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.




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. 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

  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) ]
    PA measured using actical accelerometry over 5 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) ]
    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 ]
    Measured by dual-energy x-ray absorptiometry at follow-up only



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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892983


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

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barry Taylor, Professor, University of Otago
ClinicalTrials.gov Identifier: NCT00892983     History of Changes
Other Study ID Numbers: 105891.01.P.NH
HRC 08/374 ( Other Grant/Funding Number: NZ Health Research Council )
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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