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Improving Sleep Health in Adults With Overweight or Obesity

Primary Purpose

Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TranS-C

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

TranS-C

Outcomes

Primary Outcome Measures

Recruitment rate

Percentage of potential participants screened in order to enroll 10 participants

Attrition rate

Percentage of enrolled participants completing the 8-week intervention

Completeness of questionnaire responses

Percentage of completed responses

Secondary Outcome Measures

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.

Change in sleep regularity

Change in standard deviation of actigraphic wake time.

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)'.

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.

Change in sleep timing

Change in mean actigraphic sleep midpoint.

Change in sleep efficiency

Change in mean actigraphic sleep efficiency.

Change in sleep duration

Change in mean actigraphic sleep duration.

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.

Change in systolic and diastolic blood pressure (BP)

Average of two blood pressure readings at least two minutes apart.

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.

Full Information

NCT ID

NCT04990206

First Posted

July 15, 2021

Last Updated

September 28, 2022

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT04990206

Brief Title

Improving Sleep Health in Adults With Overweight or Obesity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 7, 2021 (Actual)

Primary Completion Date

September 21, 2022 (Actual)

Study Completion Date

September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance, Sleep Wake Disorders, Sleep Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

TranS-C

Intervention Type

Behavioral

Intervention Name(s)

TranS-C

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment rate

Description

Percentage of potential participants screened in order to enroll 10 participants

Time Frame

6-months

Title

Attrition rate

Description

Percentage of enrolled participants completing the 8-week intervention

Time Frame

6-months

Title

Completeness of questionnaire responses

Description

Percentage of completed responses

Time Frame

6-months

Secondary Outcome Measure Information:

Title

Change in composite sleep health score

Description

Time Frame