Improving Sleep Health in Adults With Overweight or Obesity

NCT04990206 | Completed

• 1 other identifier: STUDY21050043
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Sleep Wake Disorders; Sleep Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in composite sleep health score

  8-weeks (baseline to post-intervention)

• Change in sleep regularity

  8-weeks (baseline to post-intervention)

• Change in sleep satisfaction

  8-weeks (baseline to post-intervention)

• Change in alertness

  8-weeks (baseline to post-intervention)

• Change in sleep timing

  8-weeks (baseline to post-intervention)

Study Arms (1)

Intervention

EXPERIMENTAL

TranS-C

Behavioral: TranS-C

Interventions

TranS-C 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher C Imes, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 4, 2021
• Study Start: October 7, 2021
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Publications are complete.
• 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.

Locations

US (1)