Improving Sleep Health in Adults With Overweight or Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2022-09-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Disturbance Sleep Wake Disorders Sleep Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

TranS-C

Group Type EXPERIMENTAL

TranS-C

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No