Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care (NCT06810557) | Clinical Trial Compass
RecruitingNot Applicable
Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
United States50 participantsStarted 2025-05-15
Plain-language summary
The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.
Who can participate
Age range
6 Years – 11 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:
* Patient at Temple Pediatrics
* Child age 6-11 years
* Child time in bed of less than 9 hours per night on most days per week
* Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile
* Understanding of and ability to complete the protocol
* Parent age at least 18 years and primary caregiver
* Willingness to be randomized to either condition
Exclusion Criteria:
* Diagnosed sleep disorder
* Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status
* Current or planned treatment for weight control
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
Achievement of enrollment goal
Timeframe: baseline
2
The number of providers who participate and refer to the intervention
Timeframe: baseline
3
Average family attendance at intervention sessions
Timeframe: baseline to 6 months
4
Nurse percent fidelity/accuracy in delivering the intervention
Timeframe: baseline to 6 months
5
Percent of families who are retained in the study at both follow-up time points
Timeframe: baseline to 6 months
6
Family assessment of the intervention's acceptability