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Investigating the moderators and mediators of an effective sleep intervention in the Prevention of Overweight in Infancy (POI) randomized controlled trial: Exploratory analyses.

ABSTRACT: The Prevention of Overweight in Infancy (POI) sleep intervention halved obesity risk at 2 years of age. However, the intervention mechanisms are unclear. Consequently, the objective of the current work was to use exploratory analyses to investigate potential moderators and mediators of the sleep intervention on obesity outcomes at age 2 years. Data were collected between 2009 and 2012. The effect of demographic and study design variables on body mass index z-score (BMI z-score) and obesity was compared in moderator subgroups at 2 years of age (n = 683, 85%). Mediating effects of child and parent-household variables assessed whether the sleep intervention resulted in meaningful changes in the mediating variable (defined as changes which were statistically significant [p < .05] or where the effect size was ≥0.15 SD), followed by assessing relationships with obesity outcomes. The sleep intervention appeared most effective in children in higher deprivation areas (effect on BMI z-score -0.25 [-0.53, 0.04], effect on obesity odds ratio [OR] 0.43 [0.16, 1.13]), and with mothers of non-European, non-Māori ethnicity (effect on BMI z-score -0.27 [-0.73, 0.20], effect on obesity OR 0.13 [95% confidence interval 0.01, 1.11]). This suggested moderation by deprivation and ethnicity. Aspects of sleep improved meaningfully in children after intervention but did not significantly relate to obesity outcomes, and other outcomes were not meaningfully affected by the sleep intervention. Thus, mediation was not indicated. Overall, the POI sleep intervention improved obesity outcomes at 2 years, and the current work identified some potential moderators, but no mediators.

SUBMITTER: Fangupo L

PROVIDER: S-EPMC9286685 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe Prevention of Overweight in Infancy (POI) randomized controlled trial 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 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 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.ObjectiveThe 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.MethodsWe will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires).ResultsThis 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 of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022.ConclusionsLong-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 preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach.Trial registrationClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf.International registered report identifier (irrid)DERR1-10.2196/24968.

Project description:BackgroundRapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care.Methods/designThis four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia.DiscussionInfancy is likely to be the most effective time to establish patterns of behaviour around food, activity and sleep that promote healthy child and adult weight. The POI.nz study will determine the extent to which sleep, food and activity interventions in infancy prevent the development of overweight.Trial registrationClinical Trials NCT00892983. Prospective meta-analysis registered on PROSPERO CRD420111188. Available from http://www.crd.york.ac.uk/PROSPERO.

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Investigating the moderators and mediators of an effective sleep intervention in the Prevention of Overweight in Infancy (POI) randomized controlled trial: Exploratory analyses.

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