Clinical trial NCT04990206: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Wake Disorders
Sleep Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6-months
measure: Attrition rate
timeFrame: 6-months
measure: Completeness of questionnaire responses
timeFrame: 6-months
Secondary outcomes:
measure: Change in composite sleep health score
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in sleep regularity
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in sleep satisfaction
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in alertness
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in sleep timing
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in sleep efficiency
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in sleep duration
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in body mass index
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in systolic and diastolic blood pressure (BP)
timeFrame: 8-weeks (baseline to post-intervention)
measure: Change in waist circumference
timeFrame: 8-weeks (baseline to post-intervention)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Christopher C Imes, PhD
role: PRINCIPAL_INVESTIGATOR
References: