Improving Sleep Health in Adults With Overweight or Obesity
- Conditions
- Sleep Wake DisordersSleep DisturbanceSleep Disorder
- Interventions
- Behavioral: TranS-C
- Registration Number
- NCT04990206
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
- Score > 32 on the Eating Habits Checklist, an eating disorder scale
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention TranS-C TranS-C
- Primary Outcome Measures
Name Time Method Completeness of questionnaire responses 6-months Percentage of completed responses
Recruitment rate 6-months Percentage of potential participants screened in order to enroll 10 participants
Attrition rate 6-months Percentage of enrolled participants completing the 8-week intervention
- Secondary Outcome Measures
Name Time Method Change in body mass index 8-weeks (baseline to post-intervention) Calculated by dividing weight in pounds by height in inches squared and multiplying by a conversion factor of 703. Weight will be measured a with Tanita Scale and Body Fat Analyzer. Height will be measured in with a stadiometer.
Change in sleep timing 8-weeks (baseline to post-intervention) Change in mean actigraphic sleep midpoint.
Change in sleep efficiency 8-weeks (baseline to post-intervention) Change in mean actigraphic sleep efficiency.
Change in sleep duration 8-weeks (baseline to post-intervention) Change in mean actigraphic sleep duration.
Change in composite sleep health score 8-weeks (baseline to post-intervention) Change in composite measure of sleep health which is the sum of scores on 6 sleep dimensions. Each dimension will be dichotomized as either 'good (1)' or 'poor (0)' based on clinically and scientifically relevant rationales and added together. Score will range from 0-6 with higher scores representing better sleep health.
Change in sleep regularity 8-weeks (baseline to post-intervention) Change in standard deviation of actigraphic wake time.
Change in sleep satisfaction 8-weeks (baseline to post-intervention) Change in Pittsburgh Sleep Quality Index (PSQI) sleep quality item. Item score ranges from 'very good (0)' to 'very bad (3)'.
Change in alertness 8-weeks (baseline to post-intervention) Change in Epworth Sleepiness Scale (ESS). Total score ranges from 0-24. Scores equal to or greater than 10 represent excessive daytime sleepiness.
Change in systolic and diastolic blood pressure (BP) 8-weeks (baseline to post-intervention) Average of two blood pressure readings at least two minutes apart.
Change in waist circumference 8-weeks (baseline to post-intervention) Measured with a Gulick II measuring tape above the right iliac crest. Will include two measurements to the nearest 0.1 cm. If the two values are within 2 cm of each other, a mean with be calculated; if not, the measurements will be repeated until they are within 2 cm of each other.
Trial Locations
- Locations (1)
University of Pittsburgh School of Nursing
🇺🇸Pittsburgh, Pennsylvania, United States