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Completed

NCT Number: NCT04990206

Improving Sleep Health in Adults With Overweight or Obesity

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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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 6-months

    Percentage of potential participants screened in order to enroll 10 participants

  2. Attrition rate

    Time frame: 6-months

    Percentage of enrolled participants completing the 8-week intervention

  3. Completeness of questionnaire responses

    Time frame: 6-months

    Percentage of completed responses

Secondary outcomes

  1. Change in composite sleep health score

    Time frame: 8-weeks (baseline to post-intervention)

    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.

  2. Change in sleep regularity

    Time frame: 8-weeks (baseline to post-intervention)

    Change in standard deviation of actigraphic wake time.

  3. Change in sleep satisfaction

    Time frame: 8-weeks (baseline to post-intervention)

    Change in Pittsburgh Sleep Quality Index (PSQI) sleep quality item. Item score ranges from 'very good (0)' to 'very bad (3)'.

  4. Change in alertness

    Time frame: 8-weeks (baseline to post-intervention)

    Change in Epworth Sleepiness Scale (ESS). Total score ranges from 0-24. Scores equal to or greater than 10 represent excessive daytime sleepiness.

  5. Change in sleep timing

    Time frame: 8-weeks (baseline to post-intervention)

    Change in mean actigraphic sleep midpoint.

  6. Change in sleep efficiency

    Time frame: 8-weeks (baseline to post-intervention)

    Change in mean actigraphic sleep efficiency.

  7. Change in sleep duration

    Time frame: 8-weeks (baseline to post-intervention)

    Change in mean actigraphic sleep duration.

  8. Change in body mass index

    Time frame: 8-weeks (baseline to post-intervention)

    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.

  9. Change in systolic and diastolic blood pressure (BP)

    Time frame: 8-weeks (baseline to post-intervention)

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

  10. Change in waist circumference

    Time frame: 8-weeks (baseline to post-intervention)

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2021
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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