Overweight and Obese Adults
Conditions
Keywords
overweight, obese, sleep, weight loss
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.
Interventions
BEHAVIORALBWL+Sleep
Participants will receive a 6-month group-based behavioral weight loss intervention that incorporates strategies to improve sleep health.
Sponsors
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of enrollment | Baseline | 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. |
| Feasibility of Outcome Measure Completion | 6 months | Outcome measure completion will be calculated by dividing the number of participants who complete outcome measures at each timepoint by the total number enrolled. |
| Intervention Acceptability | 6 months | Intervention acceptability will be assessed using validated questionnaires that assess acceptability of intervention components on a 1-5 scale. |
| Retention | 6 months | Retention will be assessed by dividing the number of participants completing the 6-month study by the total number that were enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change (kg) | Baseline (0) - 6 Months | Body weight will be measured using a digital scale, accurate to =/-0.1 kg, in the morning in a fasted state, at baseline, 3, and 6 months. The primary outcome will be change in weight from baseline to 6 months. |
| Composite sleep health score | Baseline (0) - 6 Months | The Composite Multidimensional Sleep Health Score will be assessed at baseline, 3, and 6 months. Scores range from 0-6, with a higher score indicating better sleep. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Catenacci, MD
University of Colorado, Denver
Outcome results
None listed