Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00892983




Registration number
NCT00892983
Ethics application status
Date submitted
3/05/2009
Date registered
5/05/2009
Date last updated
8/07/2020

Titles & IDs
Public title
Prevention of Overweight in Infancy
Scientific title
Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Secondary ID [1] 0 0
HRC 08/374
Secondary ID [2] 0 0
105891.01.P.NH
Universal Trial Number (UTN)
Trial acronym
POInz
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Growth 0 0
Sleep 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - FAB
Behaviour - Sleep

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

Experimental: Sleep - Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months

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


Behaviour: 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.

Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BMI z score
Timepoint [1] 0 0
24 months (end of intervention)
Primary outcome [2] 0 0
BMI z score
Timepoint [2] 0 0
60 months of age (followup at 5 years of age)
Primary outcome [3] 0 0
BMI z score
Timepoint [3] 0 0
Follow-up at 11 years of age
Secondary outcome [1] 0 0
Dietary intake
Timepoint [1] 0 0
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary outcome [2] 0 0
Television viewing
Timepoint [2] 0 0
24 months (end of intervention) and 60 months (end of follow-up)
Secondary outcome [3] 0 0
Major/ Moderate sleep problems
Timepoint [3] 0 0
24 months (end of intervention)
Secondary outcome [4] 0 0
Physical activity (PA)
Timepoint [4] 0 0
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary outcome [5] 0 0
Duration of exclusive and any breast feeding
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Parental depression score
Timepoint [6] 0 0
Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
Secondary outcome [7] 0 0
Sleep
Timepoint [7] 0 0
24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary outcome [8] 0 0
Number of night awakenings
Timepoint [8] 0 0
24 months (end of intervention) and 60 months (end of follow-up)
Secondary outcome [9] 0 0
Self-regulation
Timepoint [9] 0 0
42 and 60 months
Secondary outcome [10] 0 0
Body composition
Timepoint [10] 0 0
60 months and 11 years (further follow-up)

Eligibility
Key inclusion criteria
- Mothers booked for delivery in Dunedin, New Zealand
Minimum age
16 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
South Island

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council of NZ
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00892983
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Barry J Taylor, FRACP
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00892983