Improving Sleep Health in Adults With Overweight or Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Behavioral Intervention to Improve the Sleep Health of Adults With Obesity: A Feasibility and Acceptability Study

Conditions
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Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder

Intervention / Treatment
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* Behavioral: TranS-C


Participation Criteria
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Eligibility Criteria
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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 Score > 32 on the Eating Habits Checklist, an eating disorder scale

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>TranS-C | Behavioral: TranS-C<br>* TranS-C will be provided in eight weekly, one-on-one 50-minute sessions delivered remotely by two-way video conferencing. Each week will include goal setting and homework assignments which will be reviewed in the following session. The sessions will include information on sleep and circadian rhythms, behavioral change and motivation, and goal setting. The topics covered in the sessions include establishing regular sleep-wake times, learning a wind-down route, learning a wake-up routine, improving daytime functioning, correcting unhelpful sleep-related beliefs, and maintenance of behavior change.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Percentage of potential participants screened in order to enroll 10 participants | 6-months | 
| Attrition rate | Percentage of enrolled participants completing the 8-week intervention | 6-months | 
| Completeness of questionnaire responses | Percentage of completed responses | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite sleep health score | 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. | 8-weeks (baseline to post-intervention) | 
| Change in sleep regularity | Change in standard deviation of actigraphic wake time. | 8-weeks (baseline to post-intervention) | 
| Change in sleep satisfaction | Change in Pittsburgh Sleep Quality Index (PSQI) sleep quality item. Item score ranges from 'very good (0)' to 'very bad (3)'. | 8-weeks (baseline to post-intervention) | 
| Change in alertness | Change in Epworth Sleepiness Scale (ESS). Total score ranges from 0-24. Scores equal to or greater than 10 represent excessive daytime sleepiness. | 8-weeks (baseline to post-intervention) | 
| Change in sleep timing | Change in mean actigraphic sleep midpoint. | 8-weeks (baseline to post-intervention) | 
| Change in sleep efficiency | Change in mean actigraphic sleep efficiency. | 8-weeks (baseline to post-intervention) | 
| Change in sleep duration | Change in mean actigraphic sleep duration. | 8-weeks (baseline to post-intervention) | 
| Change in body mass index | 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. | 8-weeks (baseline to post-intervention) | 
| Change in systolic and diastolic blood pressure (BP) | Average of two blood pressure readings at least two minutes apart. | 8-weeks (baseline to post-intervention) | 
| Change in waist circumference | 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. | 8-weeks (baseline to post-intervention) |