Behavioral Weight Loss and Sleep Health Intervention (NCT07255287) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Behavioral Weight Loss and Sleep Health Intervention
United States25 participantsStarted 2025-12-10
Plain-language summary
This is a 6-month single-arm pilot and feasibility study designed to examine if a behavioral weight loss (BWL) intervention with an added sleep health program (BWL+SLEEP) can achieve clinically meaningful weight loss and improvements in a composite sleep health score. The investigators will also evaluate the feasibility of recruitment and retention of study participants and will obtain feedback from participants to improve the program's incorporation of strategies to improve sleep health.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Body Mass Index 25-40 kg/m2
* Suboptimal sleep defined as: 1) short sleep duration (actigraphy total sleep time \<6.5 hrs/night), 2) sleep irregularity (actigraphy standard deviation, SD of wake time, bed time or sleep duration \>60 min), 3) poor sleep satisfaction/quality (Pittsburgh Sleep Quality Index, PSQI single item sleep quality question response of "fairly bad" or "very bad"), 4) suboptimal sleep timing (actigraphy sleep midpoint before 2 AM or after 4 AM), 5) daytime sleepiness (Epworth Sleepiness Scale, ESS \>10) and/or 6) suboptimal sleep efficiency (actigraphy sleep efficiency \<85%).
* Physically Inactive: defined as \<150 minutes per week of exercise at moderate intensity or greater and \<60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months.
* No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, pulmonary, gastrointestinal disorders, and orthopedic problems in particular).
* No plans to relocate within the next 12 months.
* No plans for extended travel (\>2 weeks) within the next 12 months.
* Live or work within 30 minutes of the AHWC (exceptions may be made at the discretion of the Study PI).
* Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment.
* Own or willing to purchase a smartphone, willing to download and use the Oura Ring and/or Headsp…