Improving Sleep Health in Adults With Overweight or Obesity

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 21, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • TranS-C

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment rate
    • Time Frame: 6-months
    • Percentage of potential participants screened in order to enroll 10 participants
  • Attrition rate
    • Time Frame: 6-months
    • Percentage of enrolled participants completing the 8-week intervention
  • Completeness of questionnaire responses
    • Time Frame: 6-months
    • Percentage of completed responses

Secondary Measures

  • 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.
  • Change in sleep regularity
    • Time Frame: 8-weeks (baseline to post-intervention)
    • Change in standard deviation of actigraphic wake time.
  • 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)’.
  • 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.
  • Change in sleep timing
    • Time Frame: 8-weeks (baseline to post-intervention)
    • Change in mean actigraphic sleep midpoint.
  • Change in sleep efficiency
    • Time Frame: 8-weeks (baseline to post-intervention)
    • Change in mean actigraphic sleep efficiency.
  • Change in sleep duration
    • Time Frame: 8-weeks (baseline to post-intervention)
    • Change in mean actigraphic sleep duration.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher Imes, Assistant Professor – University of Pittsburgh
  • Overall Official(s)
    • Christopher C Imes, PhD, Principal Investigator, University of Pittsburgh

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