Sleep Timing, Eating and Activity Measurement Study (NCT04992611) | Clinical Trial Compass
CompletedNot Applicable
Sleep Timing, Eating and Activity Measurement Study
United States190 participantsStarted 2021-07-16
Plain-language summary
There is strong reason to believe that sleep promotion during adolescence could yield long-term health rewards; the investigators' data show that, when they get more sleep, Morning Larks have impressively reduced intake of overall calories and foods high in glycemic load that are linked to long-term health risk. Before that can be translated into major public health interventions, however, the field needs to understand why similar changes in sleep had no effect, or even an adverse effect, on adolescent Night Owls. This experimental study will clarify why there have been such discrepant effects across Morning Larks and Night Owls, with the goal of more broadly harnessing the promise of improved sleep in the prevention of obesity and long-term morbidity.
Who can participate
Age range
14 Years – 18 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.
Exclusion criteria
. Obesity, because findings are meant to inform obesity-prevention efforts
. Use of a psychiatric medication or other drug with known effects on sleep, weight, or dietary behaviors.
. Symptoms of insomnia, obstructive sleep apnea or periodic limb movement disorder, which could mask the effects of the sleep manipulation.
. Work or other obligations that require bedtime later than 9:30 pm or waking prior to 10 am (earliest bedtime and latest rise time possible during sleep extension) during the final week of the study, or other scheduling obligations that preclude participation.
. Daily consumption of \>1 coffee or "energy drink" or \>2 caffeinated sodas.
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
Overall Caloric Intake via 24-hr recall interviews using the United States Department of Agriculture (USDA) Multiple Pass Method
Timeframe: Through Study completion, up to 3 weeks for any given participant.
2
Glycemic load consumed, as measured via 24-hr recall interviews
Timeframe: Through Study completion, up to 3 weeks for any given participant.
Trial details
NCT IDNCT04992611
SponsorChildren's Hospital Medical Center, Cincinnati