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Targeting sleep, food, and activity in infants for obesity prevention: an RCT [with consumer summary]
Taylor BJ, Gray AR, Galland BC, Heath A-LM, Lawrence J, Sayers RM, Cameron S, Hanna M, Dale K, Coppell KJ, Taylor RW
Pediatrics 2017 Mar;139(3):e20162037
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: The few existing early-life obesity prevention initiatives have concentrated on nutrition and physical activity, with little examination of sleep. METHODS: This community-based, randomized controlled trial allocated 802 pregnant women (>= 16 years, < 34 weeks' gestation) to: control, FAB (food, activity, and breastfeeding), sleep, or combination (both interventions) groups. All groups received standard well-child care. FAB participants received additional support (8 contacts) promoting breastfeeding, healthy eating, and physical activity (antenatal -- 18 months). Sleep participants received 2 sessions (antenatal, 3 weeks) targeting prevention of sleep problems, as well as a sleep treatment program if requested (6 to 24 months). Combination participants received both interventions (9 contacts). BMI was measured at 24 months by researchers blinded to group allocation, and secondary outcomes (diet, physical activity, sleep) were assessed by using a questionnaire or accelerometry at multiple time points. RESULTS: At 2 years, 686 women remained in the study (86%). No significant intervention effect was observed for BMI at 24 months (p = 0.086), but there was an overall group effect for the prevalence of obesity (p = 0.027). Exploratory analyses found a protective effect for obesity among those receiving the "sleep intervention" (sleep and combination compared with FAB and control odds ratio 0.54 (95% confidence interval 0.35 to 0.82)). No effect was observed for the "FAB intervention" (FAB and combination compared with sleep and control odds ratio 1.20 (95% confidence interval 0.80 to 1.81)). CONCLUSIONS: A well-developed food and activity intervention did not seem to affect children's weight status. However, further research on more intensive or longer running sleep interventions is warranted.
Reproduced with permission from Pediatrics. Copyright by the American Academy of Pediatrics.

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