Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 14, 2020
Date Accepted: Nov 3, 2020
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Long-term follow-up of a randomized controlled trial to reduce excessive weight gain in infancy: protocol for the POI 11-year-old follow-up study
ABSTRACT
Background:
The Prevention of Overweight in Infancy (POI) randomized controlled trial (RCT) assessed the effect of a more conventional food, physical activity and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment and retention was 86% at age 2, and 77% and 69% at age 3.5 and 5 year respectively. Children who received the brief sleep intervention in infancy had just half the risk of obesity at two years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age.
Objective:
The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep.
Methods:
We will seek renewed consent from all 734 of the original 802 POI families who have expressed interest in further involvement. Children and parent(s) will attend two clinics and one home appointments to obtain measures of: anthropometry and body composition (DXA scan), 24-hour movement patterns (sleep, sedentary time and physical activity using AX3 accelerometer), mental health and wellbeing, and family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires).
Results:
This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council (HRC) of New Zealand (grant 19/346). Data collection commenced in June 2020 and first results are expected to be submitted for publication in 2022.
Conclusions:
Long term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now pre-teen population will provide much-needed evidence regarding the long term effectiveness of sleep interventions in infancy as an obesity prevention approach. Clinical Trial: ClinicalTrials.gov number NCT00892983
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