title: 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.
abstract: The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship.
  
  
  
  We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment).
  
  
  
  Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention.
  
  
  
  ClinicalTrials.gov number NCT00892983 .
authors: Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. rachael.taylor@otago.ac.nz.
authors: Rachael W
authors: RW
authors: Taylor
authors: Department of Human Nutrition, University of Otago, Dunedin, New Zealand.
authors: Anne-Louise M
authors: AL
authors: Heath
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Barbara C
authors: BC
authors: Galland
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Sonya L
authors: SL
authors: Cameron
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Julie A
authors: JA
authors: Lawrence
authors: Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.
authors: Andrew R
authors: AR
authors: Gray
authors: Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand.
authors: Gerald W
authors: GW
authors: Tannock
authors: Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand.
authors: Blair
authors: B
authors: Lawley
authors: Department of Psychology, University of Otago, Dunedin, New Zealand.
authors: Dione
authors: D
authors: Healey
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Rachel M
authors: RM
authors: Sayers
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Maha
authors: M
authors: Hanna
authors: Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand.
authors: Kim
authors: K
authors: Meredith-Jones
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Burt
authors: B
authors: Hatch
authors: Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors: Barry J
authors: BJ
authors: Taylor
mesh_terms: D001823:Body Composition; D001835:Body Weight; D001942:Breast Feeding; D002675:Child, Preschool; D004032:Diet / Q000379:methods / Q000523:psychology*; D015444:Exercise; D005247:Feeding Behavior / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D050177:Overweight / Q000517:prevention & control*; D063766:Pediatric Obesity / Q000517:prevention & control; D011314:Preventive Health Services / Q000379:methods*; D015397:Program Evaluation; D012890:Sleep; D011795:Surveys and Questionnaires; D015430:Weight Gain
keywords: Child; Diet; Infant; Obesity; Physical activity; Prevention; Self-regulation; Sleep