Prevention of Overweight in Infancy

NCT00892983 | Completed DMC

• 2 other identifiers: 105891.01.P.NHHRC 08/374
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Growth; Sleep

Keywords

Obesity; Sleep; Physical activity; Breast feeding; Depression

Outcome Measures

Primary Outcomes (3)

• BMI z score

  BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards

  24 months (end of intervention)

• BMI z score

  BMI z score derived from ht and weight and using WHO growth standards

  60 months of age (followup at 5 years of age)

• BMI z score

  BMI z score derived from height and weight and using WHO reference data

  Follow-up at 11 years of age

Secondary Outcomes (10)

• Dietary intake

  24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)

• Television viewing

  24 months (end of intervention) and 60 months (end of follow-up)

• Major/ Moderate sleep problems

  24 months (end of intervention)

• Physical activity (PA)

  24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)

• Duration of exclusive and any breast feeding

  24 months

Study Arms (4)

Standard well child care

NO INTERVENTION

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.

Food Activity Breast feeding support

EXPERIMENTAL

FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity

Behavioral: FAB

Sleep

EXPERIMENTAL

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

Behavioral: Sleep

FAB + Sleep

EXPERIMENTAL

combination of interventions used in arms 2 and 3

Behavioral: FAB; Behavioral: Sleep

Interventions

FAB BEHAVIORAL

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.

FAB + Sleep; Food Activity Breast feeding support

Sleep BEHAVIORAL

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.

FAB + Sleep; Sleep

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mothers booked for delivery in Dunedin, New Zealand

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Otago: lead
• Health Research Council of NZ: collaborator

Study Sites (1)

University of Otago

Dunedin, South Island, 9013, New Zealand

Location

Related Publications (22)

• 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.

  PMID: 27514714 BACKGROUND

• 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.

  PMID: 28238299 BACKGROUND

• 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.

  PMID: 28576897 BACKGROUND

• 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.

  PMID: 27471782 BACKGROUND

• 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.

  PMID: 26224299 BACKGROUND

• 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.

  PMID: 25995280 BACKGROUND

• 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.

  PMID: 29717271 BACKGROUND

• 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.

  PMID: 30477518 BACKGROUND

• 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.

  PMID: 30101329 BACKGROUND

• 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.

  PMID: 31122876 BACKGROUND

• 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.

  PMID: 31711093 BACKGROUND

• 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.

  PMID: 31477783 BACKGROUND

• 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.

  PMID: 32026653 BACKGROUND

• 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.

  PMID: 32372572 BACKGROUND

• 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.

  PMID: 28242860 RESULT

• Taylor RW, Haszard JJ, Meredith-Jones KA, Azeem AA, Galland BC, Heath AM, Taylor BJ, Healey D. Associations between activity, sedentary and sleep behaviours and psychosocial health in young children: a longitudinal compositional time-use study. J Act Sedentary Sleep Behav. 2023 Jan 3;2(1):3. doi: 10.1186/s44167-022-00011-3.

  PMID: 40217436 DERIVED

• Taylor RW, Galland BC, Heath AM, Gray AR, Meredith-Jones KA, Fortune SA, Sullivan TA, Adebowale T, McIntosh D, Jackson RF, Taylor BJ. Long-term follow-up of the impact of brief sleep and lifestyle interventions in infancy on BMI z-score at 11 years of age: The POI randomized controlled trial. Pediatr Obes. 2025 Mar;20(3):e13204. doi: 10.1111/ijpo.13204. Epub 2025 Jan 17.

  PMID: 39821586 DERIVED

• 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.

  PMID: 34433476 DERIVED

• 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.

  PMID: 33500114 DERIVED

• 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.

  PMID: 33252344 DERIVED

• 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.

  PMID: 30308224 DERIVED

• 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.

  PMID: 22182309 DERIVED

Related Links

• University of Otago

MeSH Terms

Conditions

Obesity; Motor Activity; Breast Feeding; Depression

Interventions

Sleep

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Barry J Taylor, FRACP

  University of Otago

  PRINCIPAL INVESTIGATOR

• Rachael Taylor, PhD

  University of Otago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2009
• First Posted: May 5, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

NZ (1)