Improving Sleep Health in Adults With Overweight or Obesity

Not Applicable

Completed

• Conditions: Sleep Wake Disorders; Sleep Disturbance; Sleep Disorder

• 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.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-04
• Study Start: 2021-10-07
• Status Verified: 2022-09
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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