A Behavioral Intervention to Improve the Sleep Health of Adults With Obesity: A Feasibility and Acceptability Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disturbance
- Sponsor
- University of Pittsburgh
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Completeness of questionnaire responses
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.
Detailed Description
Aim 1 (Primary): Examine the feasibility and acceptability of TranS-C among adults with poor sleep health and excess weight. Aim 2 (Exploratory): Explore the effect of TranS-C on the sleep health of adults with poor sleep and excess weight. Aim 3 (Exploratory): Explore the effect of TranS-C on the cardiometabolic health of adults with poor sleep and excess weight.
Investigators
Christopher Imes
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Currently own and regularly use a smart phone
- •Body mass index \>27 and ≤ 43
- •Poor sleep health on one or more of the sleep health dimensions
Exclusion Criteria
- •Presence of an unstable condition requiring physician-supervised diet and exercise
- •Physical limitations precluding ability to engage in moderate-intensity physical activity
- •Pregnant or intention to become pregnant during study
- •Current treatment for a serious mental illness
- •Being a current shift worker
- •Reported alcohol intake \> 4 drinks/day for males and \> 3 drinks/day for females
- •Current participation in a formal weight loss program, loss of ≥ 5% weight in past 6 months, or current use of weight loss medication
- •History of bariatric surgery
- •Planned extended vacations, absences, or relocation during study
- •Another member of household is a participant in the study
Outcomes
Primary Outcomes
Completeness of questionnaire responses
Time Frame: 6-months
Percentage of completed responses
Recruitment rate
Time Frame: 6-months
Percentage of potential participants screened in order to enroll 10 participants
Attrition rate
Time Frame: 6-months
Percentage of enrolled participants completing the 8-week intervention
Secondary Outcomes
- Change in body mass index(8-weeks (baseline to post-intervention))
- Change in sleep timing(8-weeks (baseline to post-intervention))
- Change in sleep efficiency(8-weeks (baseline to post-intervention))
- Change in sleep duration(8-weeks (baseline to post-intervention))
- Change in composite sleep health score(8-weeks (baseline to post-intervention))
- Change in sleep regularity(8-weeks (baseline to post-intervention))
- Change in sleep satisfaction(8-weeks (baseline to post-intervention))
- Change in alertness(8-weeks (baseline to post-intervention))
- Change in systolic and diastolic blood pressure (BP)(8-weeks (baseline to post-intervention))
- Change in waist circumference(8-weeks (baseline to post-intervention))