Prevention of Overweight in Infancy

Obesity Clinical Trial

— POInz  

Official title:

Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892983
• Other study ID #: 105891.01.P.NH
• Secondary ID: HRC 08/374
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: April 2017

Study information

• Verified date: July 2020
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Growth
• Obesity
• Sleep

Intervention

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.
• 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.

Locations

Country	Name	City	State
New Zealand	University of Otago	Dunedin	South Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Otago	Health Research Council of NZ

Country where clinical trial is conducted

New Zealand, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 May 6. doi: 10.1111/ijpo.12650. [Epub ahead of print] — View 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). pii: e20162037. doi: 10.1542/pe — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z score	BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards	24 months (end of intervention)
Primary	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)
Primary	BMI z score	BMI z score derived from height and weight and using WHO reference data	Follow-up at 11 years of age
Secondary	Dietary intake	Dietary information (foods, food groups, nutrients) via food frequency questionnaire	24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary	Television viewing	Hours of screen use by parental questionnaire	24 months (end of intervention) and 60 months (end of follow-up)
Secondary	Major/ Moderate sleep problems	Parents indicate presence of sleep problems in child	24 months (end of intervention)
Secondary	Physical activity (PA)	PA measured using actical accelerometry over 5-7 days	24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary	Duration of exclusive and any breast feeding	Measured by repeated questionnaire	24 months
Secondary	Parental depression score	Edinburgh Postnatal Depression questionnaire	Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
Secondary	Sleep	Measured by questionnaire and accelerometry at multiple timepoints	24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
Secondary	Number of night awakenings	Measured by questionnaire and accelerometry at multiple timepoints	24 months (end of intervention) and 60 months (end of follow-up)
Secondary	Self-regulation	Measured by questionnaire and laboratory based measures at follow-up only	42 and 60 months
Secondary	Body composition	Measured by dual-energy x-ray absorptiometry at follow-up only	60 months and 11 years (further follow-up)

External Links

•   University of Otago