Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder
Conditions
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.
Interventions
BEHAVIORALTranS-C
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.
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Completeness of questionnaire responses | 6-months | Percentage of completed responses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| Change in sleep duration | 8-weeks (baseline to post-intervention) | Change in mean actigraphic sleep duration. |
| 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)'. |
Countries
United States
Outcome results
None listed