Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese … (NCT04236882) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sleep and Physical Activity Intervention for Increasing Physical Activity in Overweight or Obese and Sedentary African Americans
United States28 participantsStarted 2019-10-04
Plain-language summary
This trial studies how well sleep and physical activity interventions work in increasing the physical activity of overweight or obese and sedentary African Americans. Sleep and physical activity interventions may help to increase physical activity among overweight and obese African American adults who do not get enough exercise.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sedentary (not meeting Physical Activity Guidelines)
* Overweight and/or obese adults (body mass index range: 25.0 or greater)
* Average habitual sleep duration of =\< 6 hours
* Access to internet
* Self-identify as black or African American
* Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if endorsing any items on the PAR-Q
Exclusion Criteria:
* Pre-existing sleep disorder (i.e., insomnia, sleep apnea, restless leg syndrome, narcolepsy, and sleep walking disorder via self-report)
* High risk for obstructive sleep apnea (i.e., STOP-BANG score \> 5)
* Psychiatric disorder (current risk of severe depression as measured by Center for Epidemiologic Studies Depression Scale \[CESD\] \> 15 with/without past history of diagnosed Diagnostic and Statistical Manual of Mental Disorders \[DSM-V\] disorder)
* Self-reported physician diagnosed thyroid condition that is not currently being treated
* Shift work or employment that requires weekly flights to a different time zone or overnight travel
* Enrolled in weight management program
* Excessive caffeine intake (\> 400 mg caffeine intake/day or the equivalent of \> 4 cups of coffee)
* Plans to change residence out of Houston within the next 3 months
* Self-reported pregnancy or less than 4 months postpartum
* Participated in formative focus groups/individual interv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the f easibility of a brief sleep intervention prior to or following a physical activity (PA) intervention
Timeframe: Up to 9 weeks
2
Satisfaction of a brief sleep intervention prior to or following a PA intervention