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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | TranS-C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TranS-C | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher C Imes, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Nursing | Pittsburgh | Pennsylvania | 15213 | United States |
Final data sets from the proposed research may be shared.
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Publications are complete.
A Limited Dataset (LDS) may be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |