Scaling up Building Healthy Families (NCT07404839) | Clinical Trial Compass
RecruitingNot Applicable
Scaling up Building Healthy Families
United States150 participantsStarted 2025-11-01
Plain-language summary
Evidence-based interventions for childhood obesity (EBI-CO) can improve children's weight status, but families in rural areas and small cities have limited access to the interdisciplinary healthcare teams recommended to deliver EBI-CO. To address this issue, the investigators adapted an EBI-CO, Building Healthy Families (BHF), which includes all materials and training resources necessary for rural program implementation. The pilot study found that when paired with opportunities to learn from the program developers and other community implementation teams, the packaged program led to effective delivery across 4 rural communities. This scale-up study will compare packaged BHF Resources with and without a learning collaborative facilitation strategy, examining outcomes including reach, effectiveness, implementation, and potential for sustainability in rural areas.
Who can participate
Age range
5 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.
Communities must respond to a call for proposals by submitting a letter of intent and a brief narrative describing the local need for BHF and readiness for implementation. Community eligibility for this trial includes:
* Any community is eligible to apply for the competitive BHF RFA process;
* BHF RFA scoring prioritizes community narratives that meet the following criteria: (1)Childhood obesity prevention and treatment are a priority health concern; (2) Communities and community-based organizations located in rural, frontier, or micropolitan areas, and/or that provide services to families from these areas; (3) Communities and community-based organizations that provide services or reach families in other low-resource contexts, such as areas with limited access to evidence-based health promotion and disease prevention/treatment interventions.
* The community is willing to be randomized to either study condition.
* The community is willing to form a Community Implementation Team (CIT) to implement BHF.
Eligibility for Community Implementation Teams (CIT) includes:
* Adults, age 18 years or older
* Employed by or affiliated with the community-based organizations that applied and were selected through the bundled adoption strategy (i.e., LOI/RFA) process.
BHF Program Family Eligibility:
* Must have at least one child between the ages of 5 and 13 years with a BMI at or above the 85th percentile;
* One parent or caregiver must agree to attend BHF sessions with the child.
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
Implementation Fidelity (community level)
Timeframe: From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.