Prevention of Overweight in Infancy (POInz)
Primary Purpose
Obesity, Growth, Sleep
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
FAB
Sleep
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Sleep, Physical activity, Breast feeding, Depression
Eligibility 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.
Sites / Locations
- University of Otago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Standard well child care
Food Activity Breast feeding support
Sleep
FAB + Sleep
Arm Description
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.
FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
combination of interventions used in arms 2 and 3
Outcomes
Primary Outcome Measures
BMI z score
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
BMI z score
BMI z score derived from ht and weight and using WHO growth standards
BMI z score
BMI z score derived from height and weight and using WHO reference data
Secondary Outcome Measures
Dietary intake
Dietary information (foods, food groups, nutrients) via food frequency questionnaire
Television viewing
Hours of screen use by parental questionnaire
Major/ Moderate sleep problems
Parents indicate presence of sleep problems in child
Physical activity (PA)
PA measured using actical accelerometry over 5-7 days
Duration of exclusive and any breast feeding
Measured by repeated questionnaire
Parental depression score
Edinburgh Postnatal Depression questionnaire
Sleep
Measured by questionnaire and accelerometry at multiple timepoints
Number of night awakenings
Measured by questionnaire and accelerometry at multiple timepoints
Self-regulation
Measured by questionnaire and laboratory based measures at follow-up only
Body composition
Measured by dual-energy x-ray absorptiometry at follow-up only
Full Information
NCT ID
NCT00892983
First Posted
May 3, 2009
Last Updated
July 6, 2020
Sponsor
University of Otago
Collaborators
Health Research Council of NZ
1. Study Identification
Unique Protocol Identification Number
NCT00892983
Brief Title
Prevention of Overweight in Infancy
Acronym
POInz
Official Title
Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Otago
Collaborators
Health Research Council of NZ
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 follow-ups at 3.5, 5 and 11 years of age.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Growth, Sleep
Keywords
Obesity, Sleep, Physical activity, Breast feeding, Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
802 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard well child care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Food Activity Breast feeding support
Arm Type
Experimental
Arm Description
FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity
Arm Title
Sleep
Arm Type
Experimental
Arm Description
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
Arm Title
FAB + Sleep
Arm Type
Experimental
Arm Description
combination of interventions used in arms 2 and 3
Intervention Type
Behavioral
Intervention Name(s)
FAB
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep
Intervention Description
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 Measure Information:
Title
BMI z score
Description
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
Time Frame
24 months (end of intervention)
Title
BMI z score
Description
BMI z score derived from ht and weight and using WHO growth standards
Time Frame
60 months of age (followup at 5 years of age)
Title
BMI z score
Description
BMI z score derived from height and weight and using WHO reference data
Time Frame
Follow-up at 11 years of age
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Dietary information (foods, food groups, nutrients) via food frequency questionnaire
Time Frame
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Title
Television viewing
Description
Hours of screen use by parental questionnaire
Time Frame
24 months (end of intervention) and 60 months (end of follow-up)
Title
Major/ Moderate sleep problems
Description
Parents indicate presence of sleep problems in child
Time Frame
24 months (end of intervention)
Title
Physical activity (PA)
Description
PA measured using actical accelerometry over 5-7 days
Time Frame
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Title
Duration of exclusive and any breast feeding
Description
Measured by repeated questionnaire
Time Frame
24 months
Title
Parental depression score
Description
Edinburgh Postnatal Depression questionnaire
Time Frame
Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
Title
Sleep
Description
Measured by questionnaire and accelerometry at multiple timepoints
Time Frame
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Title
Number of night awakenings
Description
Measured by questionnaire and accelerometry at multiple timepoints
Time Frame
24 months (end of intervention) and 60 months (end of follow-up)
Title
Self-regulation
Description
Measured by questionnaire and laboratory based measures at follow-up only
Time Frame
42 and 60 months
Title
Body composition
Description
Measured by dual-energy x-ray absorptiometry at follow-up only
Time Frame
60 months and 11 years (further follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry J Taylor, FRACP
Organizational Affiliation
University of Otago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachael Taylor, PhD
Organizational Affiliation
University of Otago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Otago
City
Dunedin
State/Province
South Island
ZIP/Postal Code
9013
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
27514714
Citation
Taylor RW, Heath AL, Galland BC, Cameron SL, Lawrence JA, Gray AR, Tannock GW, Lawley B, Healey D, Sayers RM, Hanna M, Meredith-Jones K, Hatch B, Taylor BJ. Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study. BMC Public Health. 2016 Aug 11;16(1):771. doi: 10.1186/s12889-016-3383-4.
Results Reference
background
PubMed Identifier
28238299
Citation
Taylor RW, Iosua E, Heath AM, Gray AR, Taylor BJ, Lawrence JA, Hanna M, Cameron SL, Sayers R, Galland B. Eating frequency in relation to BMI in very young children: a longitudinal analysis. Public Health Nutr. 2017 Jun;20(8):1372-1379. doi: 10.1017/S1368980017000143. Epub 2017 Feb 27.
Results Reference
background
PubMed Identifier
28576897
Citation
Galland BC, Sayers RM, Cameron SL, Gray AR, Heath AM, Lawrence JA, Newlands A, Taylor BJ, Taylor RW. Anticipatory guidance to prevent infant sleep problems within a randomised controlled trial: infant, maternal and partner outcomes at 6 months of age. BMJ Open. 2017 Jun 2;7(5):e014908. doi: 10.1136/bmjopen-2016-014908.
Results Reference
background
PubMed Identifier
27471782
Citation
Moir C, Meredith-Jones K, Taylor BJ, Gray A, Heath AM, Dale K, Galland B, Lawrence J, Sayers RM, Taylor RW. Early Intervention to Encourage Physical Activity in Infants and Toddlers: A Randomized Controlled Trial. Med Sci Sports Exerc. 2016 Dec;48(12):2446-2453. doi: 10.1249/MSS.0000000000001055.
Results Reference
background
PubMed Identifier
26224299
Citation
Fangupo LJ, Heath AL, Williams SM, Somerville MR, Lawrence JA, Gray AR, Taylor BJ, Mills VC, Watson EO, Galland BC, Sayers RM, Hanna MB, Taylor RW. Impact of an early-life intervention on the nutrition behaviors of 2-y-old children: a randomized controlled trial. Am J Clin Nutr. 2015 Sep;102(3):704-12. doi: 10.3945/ajcn.115.111823. Epub 2015 Jul 29.
Results Reference
background
PubMed Identifier
25995280
Citation
Cameron SL, Heath AL, Gray AR, Churcher B, Davies RS, Newlands A, Galland BC, Sayers RM, Lawrence JA, Taylor BJ, Taylor RW. Lactation Consultant Support from Late Pregnancy with an Educational Intervention at 4 Months of Age Delays the Introduction of Complementary Foods in a Randomized Controlled Trial. J Nutr. 2015 Jul;145(7):1481-90. doi: 10.3945/jn.114.202689. Epub 2015 May 20.
Results Reference
background
PubMed Identifier
29717271
Citation
Meredith-Jones K, Haszard J, Moir C, Heath AL, Lawrence J, Galland B, Taylor B, Gray A, Sayers R, Taylor R. Physical activity and inactivity trajectories associated with body composition in pre-schoolers. Int J Obes (Lond). 2018 Sep;42(9):1621-1630. doi: 10.1038/s41366-018-0058-5. Epub 2018 Mar 15.
Results Reference
background
PubMed Identifier
30477518
Citation
Taylor RW, Haszard JJ, Meredith-Jones KA, Galland BC, Heath AM, Lawrence J, Gray AR, Sayers R, Hanna M, Taylor BJ. 24-h movement behaviors from infancy to preschool: cross-sectional and longitudinal relationships with body composition and bone health. Int J Behav Nutr Phys Act. 2018 Nov 26;15(1):118. doi: 10.1186/s12966-018-0753-6.
Results Reference
background
PubMed Identifier
30101329
Citation
Taylor RW, Gray AR, Heath AM, Galland BC, Lawrence J, Sayers R, Healey D, Tannock GW, Meredith-Jones KA, Hanna M, Hatch B, Taylor BJ. Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. Am J Clin Nutr. 2018 Aug 1;108(2):228-236. doi: 10.1093/ajcn/nqy090.
Results Reference
background
PubMed Identifier
31122876
Citation
Hatch B, Galland BC, Gray AR, Taylor RW, Sayers R, Lawrence J, Taylor B. Consistent use of bedtime parenting strategies mediates the effects of sleep education on child sleep: secondary findings from an early-life randomized controlled trial. Sleep Health. 2019 Oct;5(5):433-443. doi: 10.1016/j.sleh.2019.03.002. Epub 2019 May 20.
Results Reference
background
PubMed Identifier
31711093
Citation
Leong C, Haszard JJ, Heath AM, Tannock GW, Lawley B, Cameron SL, Szymlek-Gay EA, Gray AR, Taylor BJ, Galland BC, Lawrence JA, Otal A, Hughes A, Taylor RW. Using compositional principal component analysis to describe children's gut microbiota in relation to diet and body composition. Am J Clin Nutr. 2020 Jan 1;111(1):70-78. doi: 10.1093/ajcn/nqz270.
Results Reference
background
PubMed Identifier
31477783
Citation
Meredith-Jones K, Galland B, Haszard J, Gray A, Sayers R, Hanna M, Taylor B, Taylor R. Do young children consistently meet 24-h sleep and activity guidelines? A longitudinal analysis using actigraphy. Int J Obes (Lond). 2019 Dec;43(12):2555-2564. doi: 10.1038/s41366-019-0432-y. Epub 2019 Sep 2.
Results Reference
background
PubMed Identifier
32026653
Citation
Askie LM, Espinoza D, Martin A, Daniels LA, Mihrshahi S, Taylor R, Wen LM, Campbell K, Hesketh KD, Rissel C, Taylor B, Magarey A, Seidler AL, Hunter KE, Baur LA. Interventions commenced by early infancy to prevent childhood obesity-The EPOCH Collaboration: An individual participant data prospective meta-analysis of four randomized controlled trials. Pediatr Obes. 2020 Jun;15(6):e12618. doi: 10.1111/ijpo.12618. Epub 2020 Feb 6.
Results Reference
background
PubMed Identifier
32372572
Citation
Roy M, Haszard JJ, Savage JS, Yolton K, Beebe DW, Xu Y, Galland B, Paul IM, Mindell JA, Mihrshahi S, Wen LM, Taylor B, Richards R, Te Morenga L, Taylor RW. Bedtime, body mass index and obesity risk in preschool-aged children. Pediatr Obes. 2020 Sep;15(9):e12650. doi: 10.1111/ijpo.12650. Epub 2020 May 6.
Results Reference
background
PubMed Identifier
28242860
Citation
Taylor BJ, Gray AR, Galland BC, Heath AM, Lawrence J, Sayers RM, Cameron S, Hanna M, Dale K, Coppell KJ, Taylor RW. Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCT. Pediatrics. 2017 Mar;139(3):e20162037. doi: 10.1542/peds.2016-2037.
Results Reference
result
PubMed Identifier
34433476
Citation
Taylor RW, Haszard JJ, Healey D, Meredith-Jones KA, Taylor BJ, Galland BC. Adherence to 24-h movement behavior guidelines and psychosocial functioning in young children: a longitudinal analysis. Int J Behav Nutr Phys Act. 2021 Aug 25;18(1):110. doi: 10.1186/s12966-021-01185-w.
Results Reference
derived
PubMed Identifier
33500114
Citation
Fangupo LJ, Haszard JJ, Taylor BJ, Gray AR, Lawrence JA, Taylor RW. Ultra-Processed Food Intake and Associations With Demographic Factors in Young New Zealand Children. J Acad Nutr Diet. 2021 Feb;121(2):305-313. doi: 10.1016/j.jand.2020.08.088. Epub 2020 Oct 21.
Results Reference
derived
PubMed Identifier
33252344
Citation
Adebowale TO, Taylor BJ, Gray AR, Galland BC, Heath AM, Fortune S, Meredith-Jones KA, Sullivan T, McIntosh D, Brosnan B, Taylor RW. Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years. JMIR Res Protoc. 2020 Nov 30;9(11):e24968. doi: 10.2196/24968.
Results Reference
derived
PubMed Identifier
30308224
Citation
Haszard JJ, Russell CG, Byrne RA, Taylor RW, Campbell KJ. Early maternal feeding practices: Associations with overweight later in childhood. Appetite. 2019 Jan 1;132:91-96. doi: 10.1016/j.appet.2018.10.008. Epub 2018 Oct 9.
Results Reference
derived
PubMed Identifier
22182309
Citation
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.
Results Reference
derived
Links:
URL
http://www.otago.ac.nz
Description
University of Otago
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Prevention of Overweight in Infancy
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