Improving Sleep Health in Adults With Overweight or Obesity

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990206
• Other study ID #: STUDY21050043
• Status: Completed
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: September 21, 2022

Study information

• Verified date: September 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• TranS-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.

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Nursing	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Percentage of potential participants screened in order to enroll 10 participants	6-months
Primary	Attrition rate	Percentage of enrolled participants completing the 8-week intervention	6-months
Primary	Completeness of questionnaire responses	Percentage of completed responses	6-months
Secondary	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)
Secondary	Change in sleep regularity	Change in standard deviation of actigraphic wake time.	8-weeks (baseline to post-intervention)
Secondary	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)
Secondary	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)
Secondary	Change in sleep timing	Change in mean actigraphic sleep midpoint.	8-weeks (baseline to post-intervention)
Secondary	Change in sleep efficiency	Change in mean actigraphic sleep efficiency.	8-weeks (baseline to post-intervention)
Secondary	Change in sleep duration	Change in mean actigraphic sleep duration.	8-weeks (baseline to post-intervention)
Secondary	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)
Secondary	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)
Secondary	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)