Mobile Integrated Care for Childhood Obesity (NCT05936385) | Clinical Trial Compass
CompletedNot Applicable
Mobile Integrated Care for Childhood Obesity
United States59 participantsStarted 2023-07-26
Plain-language summary
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.
Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.
The other group will be in our Healthy Lifestyle program for 6 months. This will include:
* Check-ins with lifestyle specialists and community health workers,
* A mobile app to help support a healthy lifestyle, and
* Access to community programs and activities.
The main questions the study aims to answer are:
* Do children in the Healthy Lifestyle program have better weight outcomes?
* Do more families in the Healthy Lifestyle program stay in the study?
* Does the Healthy Lifestyle program work better for families from certain communities?
Who can participate
Age range
4 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.
Caregiver and child dyads will be enrolled
Inclusion Criteria:
* Child 4-12 years of age
* Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
* Child has a BMI ≥ 95% for age and sex
* Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)
Exclusion Criteria:
* Caregiver not child's legal guardian
* Caregiver not proficient in English or Spanish
* Caregiver does not have a device and reliable internet
* Child has a genetic syndrome or endocrine disorder that predisposes to obesity
* Child is on a medication that impacts weight
* Child is already enrolled in a weight management program
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.