ArticlePilot and feasibility studies2025
An internet-assisted sleep, dietary, and physical activity intervention to support weight-loss among postpartum people (Sleep GOALS): protocol for a pilot randomized controlled trial.
Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05942326 (Sleep GOALS), which is not on this map. Not yet cited in PubMed.
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Sleep GOALS (Goal-focused Online Access to Lifestyle Support), an Internet Assisted Diet, Physical Activity, and Sleep Weight Loss Intervention for Postpartum Women
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Abstract
backgroundPostpartum weight retention and maternal obesity are associated with short- and long-term maternal morbidity and mortality risk. Most weight-loss interventions among postpartum individuals follow evidence-based lifestyle recommendations but have produced only modest effects and have had substantial heterogeneity. We developed a novel internet-assisted weight management intervention for postpartum people that integrates concepts for improving sleep health within a diet and physical activity-focused intervention. We describe the intervention protocol and discuss how the pilot study's findings will inform future development and evaluation.
methodsWe will recruit 40 postpartum individuals with overweight or obesity from Western Pennsylvania to participate in a single-blind, parallel-arm, randomized controlled trial design. Participants will be randomized at a 1:1 ratio to the Sleep GOALS (Goal-focused Online Access to Lifestyle Support) intervention or education control group. The Sleep GOALS intervention includes interactive lessons addressing sleep, diet, physical activity, behavioral self-monitoring tools, and a lifestyle coach to provide accountability, encouragement, and personalized support. The education control group will receive brochures from the American Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women), SNAP education connection (e.g., family-friendly activities, meal planning), and the U.S. Department of Health and Human Services (e.g., physical activity promotion during and after pregnancy). Primary study outcomes include the intervention feasibility (i.e., recruitment, enrollment, attrition rates, intervention engagement) and acceptability (i.e., participant ratings of the intervention delivery, curricula, approach to behavioral self-monitoring, action plans, intervention platform, and coaching). Secondary outcomes include weight loss and retention of pregnancy and postpartum weight gain. DISCUSSION: Incorporating a holistic approach that addresses sleep health alongside diet and physical activity, the Sleep GOALS intervention aims to not only facilitate weight loss but also enhance overall maternal well-being. Pilot testing will help us identify and refine factors related to the conduct of the planned larger, definitive trial and estimate the change in secondary outcomes.
trial registrationNCT05942326.
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