Behavioral Weight Loss and Sleep Health Intervention

NCT07255287 | Active Not Recruiting

• 2 other identifiers: 23-13171K24HL169755
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obese Adults

Keywords

overweight; obese; sleep; weight loss

Outcome Measures

Primary Outcomes (4)

• Feasibility of enrollment

  Feasibility of enrollment will be assessed by whether the study team can enroll the target sample size of n=20 individuals in the study over a 3-4 month period.

  Baseline

• Feasibility of Outcome Measure Completion

  Outcome measure completion will be calculated by dividing the number of participants who complete outcome measures at each timepoint by the total number enrolled.

  6 months

• Intervention Acceptability

  Intervention acceptability will be assessed using validated questionnaires that assess acceptability of intervention components on a 1-5 scale.

  6 months

• Retention

  Retention will be assessed by dividing the number of participants completing the 6-month study by the total number that were enrolled.

  6 months

Secondary Outcomes (2)

• Weight change (kg)

  Baseline (0) - 6 Months

• Composite sleep health score

  Baseline (0) - 6 Months

Study Arms (1)

Behavioral Weight Loss Program Plus Sleep Health Intervention

EXPERIMENTAL

Participants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.

Behavioral: BWL+Sleep

Interventions

BWL+Sleep BEHAVIORAL

Participants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.

Behavioral Weight Loss Program Plus Sleep Health Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Own or willing to purchase a smartphone, willing to download and use the Oura Ring and/or Headspace App if randomized to these components. (Data from the Pew Research Center 2024 Mobile Fact Sheet suggests \>95% of adults in our target age range own a smartphone)
• Have a primary care physician (or are willing to establish care prior to study enrollment) to address any medical issues which may arise during screening procedures or study interventions.
• No contraindications to exercise or limitations on ability to be physically active.
• Agree to refrain from use of anti-obesity medications (AOMs) agents during the 6-month pilot study.
• For Females:
• Not currently pregnant or lactating,
• Not pregnant within the past 6 months,
• Not planning to become pregnant in the next 12 months. Sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception.
• Diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
• Diabetes (fasting glucose greater than or equal to 126 mg/dL or Hemoglobin A1C greater than or equal to 6.5%) as measured during the screening visit.
• Undiagnosed hypo- or hyper-thyroid (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
• Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit.
• Triglycerides \>400 mg/dL as measured on the screening visit.
• LDL cholesterol \>200 mg/dL as measured on the screening visit.
• Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Victoria Catenacci, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: December 1, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data that can be shared will be made available at the time of associated publication(s) (data underlying peer- reviewed journal articles). Data that can be shared will be available for 3 years after the last publication.
• Access Criteria: Data will be shared in a generalist repository as controlled access. Our institutional IRB currently does not allow public (open access) sharing of individual participant data. Repository access will be granted to qualified individuals within the scientific community who request access to validate and replicate the published research findings or to perform analyses that align with the research aims outlined in the approved protocol. Data users also agree not to share or redistribute any data downloads. Any publications or presentations resulting from the use of the shared dataset must appropriately acknowledge the data source, appropriately list authors (approved by Study PI), and cite the associated publications. The requester's institutional IRB or equivalent body must approve the requested use of the data. To gain access, data requestors will need to sign a data transfer agreement outlining agreement with the above conditions.

Locations

US (1)