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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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.
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States
Recruitment rate
Percentage of potential participants screened in order to enroll 10 participants
Time frame: 6-months
Attrition rate
Percentage of enrolled participants completing the 8-week intervention
Time frame: 6-months
Completeness of questionnaire responses
Percentage of completed responses
Time frame: 6-months
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.
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep regularity
Change in standard deviation of actigraphic wake time.
Time frame: 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)'.
Time frame: 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.
Time frame: 8-weeks (baseline to post-intervention)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in sleep timing
Change in mean actigraphic sleep midpoint.
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep efficiency
Change in mean actigraphic sleep efficiency.
Time frame: 8-weeks (baseline to post-intervention)
Change in sleep duration
Change in mean actigraphic sleep duration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8-weeks (baseline to post-intervention)