Improving Sleep Health in Adults With Overweight or Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Wake Disorders; Sleep Disorder; Sleep Disturbance
• Intervention / Treatment: Behavioral: TranS-C

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; TranS-C

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Christopher C Imes, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: STUDY21050043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Final data sets from the proposed research may be shared.
• IPD Sharing Time Frame: Publications are complete.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No