Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity (NCT05107726) | Clinical Trial Compass
CompletedNot Applicable
Piloting a Family-Based Intervention of Time-Restricted Eating to Treat Obesity
United States36 participantsStarted 2022-03-30
Plain-language summary
This study will test whether managing the hours during which people eat, called time restricted eating, might help them to lose weight. For this study, one parent and a child will enroll as a group (called a dyad).
The dyads will be assigned at random to practice time restricted eating (within 10-12 hours per day) but will be able to eat whatever they would like or to limit portion size and increase fruit, vegetable and lean protein intake and limit sugar sweetened beverages and undergo . Both groups will receive dietary counseling, Bluetooth toothbrushes and scales to help monitor their progress.
The study will last for 12 weeks and will have one survey four weeks after the last in person visit. There will be 2 in person visits, 7 virtual visits, 2 phone visits and daily time logs.
Who can participate
Age range
3 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:
* BMI \>/= 30 kg/m2 for the parent
* BMI \> 95th percentile for the child
* Age 3-9 years for the child
* Age \>/= 18 years old for the parent
Exclusion Criteria:
* Concurrent participation in another weight loss study
* Taking any medications for weight loss
* Pregnancy or anticipation of pregnancy in next 6 months (for the parent)
* 3+ on Eating Disorder Survey
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
Change in BMI for Pediatric Participants
Timeframe: Change from baseline to 12 weeks. Table contains CHILDREN only.