A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy

Abstract

Childhood overweight and obesity is a worldwide public health issue. Our objective was to describe planned, ongoing and completed randomized controlled trials (RCTs) designed for the prevention of obesity in early childhood. Two databases (World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov) were searched to identify RCTs with the primary aim of preventing childhood obesity and at least one outcome related to child weight. Interventions needed to start in the first two years of childhood or earlier, continue for at least 6 months postnatally, include a component related to lifestyle or behaviours, and have a follow up time of at least 2 years. We identified 29 unique RCTs, implemented since 2008, with most being undertaken in high income countries. Interventions ranged from advice on diet, activity, sleep, emotion regulation, and parenting education through to individual home visits, clinic-based consultations, or group education sessions. Eleven trials published data on child weight-related outcomes to date, though most were not sufficiently powered to detect significant effects. Many trials detected improvements in practices such as breastfeeding, screen time, and physical activity in the intervention groups compared to the control groups. Further follow-up of ongoing trials is needed to assess longer-term effects.

A rapid review of the scalability of interventions targeting obesity prevention in infants

“…A total of 14 RCTs were identified from the review (16) and formed the basis of forward searching (listed in Supplementary Table 1). A total of 1929 citations were obtained and 624 citations remained after de-duplication and 185 relevant papers were included after title and abstract screen.…”

“…We undertook a rapid review using all prescale trials included in a recent review with published outcomes undertaken by Mihrshahi et al (16) summarizing the effect of RCTs targeting nutrition, physical activity and obesity prevention in 0-2 year old children. To be included as a candidate for potential scale-up, the intervention was required to have reported a statistically significant effect on at least one weight, physical activity, nutrition, or parental feeding outcome.…”

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

“…First, the POI sleep intervention was brief, consisting in most cases of only two perinatal parent contacts (group education session in late pregnancy and home visit at 3 weeks post‐partum). While it has been suggested that interventions of long duration may be necessary to create sustained change, 28 these findings indicate that there is potential for sleep interventions to be brief, economical, 29 and effective 12,14 . Second, while the mean difference in BMI z ‐score at age 2 years may be considered small at −0.15 (95% CI −0.28 to −0.01), it agrees with a recent review of RCTs for the prevention of obesity in infancy, which found that differences in BMI z ‐scores reported ranged from −0.01 to −0.30 28 .…”

“…While it has been suggested that interventions of long duration may be necessary to create sustained change, 28 these findings indicate that there is potential for sleep interventions to be brief, economical, 29 and effective 12,14 . Second, while the mean difference in BMI z ‐score at age 2 years may be considered small at −0.15 (95% CI −0.28 to −0.01), it agrees with a recent review of RCTs for the prevention of obesity in infancy, which found that differences in BMI z ‐scores reported ranged from −0.01 to −0.30 28 . It has been suggested that in early childhood obesity interventions, differences in mean BMI z ‐scores of as little as −0.12, if replicated widely, are enough to make important differences at a public health level 5 .…”

“… 12 , 14 Second, while the mean difference in BMI z ‐score at age 2 years may be considered small at −0.15 (95% CI −0.28 to −0.01), it agrees with a recent review of RCTs for the prevention of obesity in infancy, which found that differences in BMI z ‐scores reported ranged from −0.01 to −0.30. 28 It has been suggested that in early childhood obesity interventions, differences in mean BMI z ‐scores of as little as −0.12, if replicated widely, are enough to make important differences at a public health level. 5 This points to the success of the POI sleep intervention, and to a need to understand why, and for whom, the sleep intervention had a beneficial effect on obesity outcomes.…”