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

Study Protocol

Anne-Louise M. Heath¹  Rachael W. Taylor²  Kim Meredith-Jones²  Blair Lawley³  Gerald W. Tannock³  Andrew R. Gray⁴  Dione Healey⁵  Rachel M. Sayers⁶  Barry J. Taylor⁶  Barbara C. Galland⁶  Burt Hatch⁶  Sonya L. Cameron⁶  Maha Hanna⁶  Julie A. Lawrence⁶ 

[1] Department of Human Nutrition, University of Otago, Dunedin, New Zealand;Department of Medicine, University of Otago, PO Box 56, 9054, Dunedin, New Zealand;Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand;Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand;Department of Psychology, University of Otago, Dunedin, New Zealand;Department of Women’s and Children’s Health, University of Otago, Dunedin, New Zealand;

关键词: Infant;    Child;    Obesity;    Prevention;    Sleep;    Diet;    Physical activity;    Self-regulation;   

DOI  :  10.1186/s12889-016-3383-4

 received in 2016-07-01, accepted in 2016-07-27,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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/designWe 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).DiscussionOur 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 registrationClinicalTrials.gov number NCT00892983.

【 授权许可】

CC BY   
© The Author(s). 2016