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.


Background: 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.

Methods/design: 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).

Discussion: 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.

Trial registration: number NCT00892983 .

Keywords: Child; Diet; Infant; Obesity; Physical activity; Prevention; Self-regulation; Sleep.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Body Composition
  • Body Weight
  • Breast Feeding
  • Child, Preschool
  • Diet / methods
  • Diet / psychology*
  • Exercise*
  • Feeding Behavior / psychology
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Male
  • Overweight / prevention & control*
  • Pediatric Obesity / prevention & control
  • Preventive Health Services / methods*
  • Program Evaluation
  • Sleep*
  • Surveys and Questionnaires
  • Weight Gain

Associated data