Background Postpartum 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 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.

Methods We 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 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.

Over the past three years, Dr. Daniel Buysse has been a paid or unpaid consultant to Sleep Number, Idorsia, and Eisai. All consulting agreements have been for less than $5000 per year from any single entity. Dr. Daniel Buysse is an author of the Pittsburgh Sleep Quality Index, Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A), Brief Pittsburgh Sleep Quality Index (B-PSQI), Daytime Insomnia Symptoms Scale, Pittsburgh Sleep Diary, Insomnia Symptom Questionnaire, and RU_SATED (copyrights held by the University of Pittsburgh). These instruments have been licensed to commercial entities for fees. He is also co-author of the Consensus Sleep Diary (copyright held by Ryerson University), which is licensed to commercial entities for a fee. He has received grant support from NIH, PCORI, AHRQ, and the VA. Dr. Esa Davis is a member of the United States Preventive Services Task Force (USPSTF). Dr. Judy Chang is a member of the National Academies of Science, Engineering, and Medicine (NASEM) standing committee on Reproductive Health, Equity, and Society. This article does not necessarily represent the views and policies of the USPSTF or NASEM.

NCT05942326

The National Heart Lung Blood Institute 1K01 HL161439-01 funded this study

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The University of Pittsburgh Institutional Review Board approved this studys protocol on April 19th 2023. All participants will be required to provide consent prior to enrollment and baseline assessments.

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