NCT07404839 · University of Utah
Scaling up Building Healthy Families
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Building Healthy Families Program
Building Healthy Families (BHF) is an evidence-based, family-based weight management program designed for children aged 5-13 who are overweight or obese and their parents or caregivers. Family-based weight management programs focus on creating a supportive, positive environment for lifestyle behavior change that promotes healthy growth and development. BHF is a group-based program, and education sessions focus on healthy eating, physical activity, and lifestyle modification for the entire family. The BHF Program consists of 12 weekly education sessions (\~2 hours each) and 6 relapse-prevention refresher sessions over 1 year (12 months total). The BHF program meets the current recommendations for intensive health behavior and lifestyle treatment (IHBLT) programs from professional groups, and BHF is a recommended program for community adoption and implementation.
Primary outcome measures
Implementation Fidelity (community level)
Time frame: From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.
The primary implementation-fidelity outcome will be measured by direct observation and is defined as the number of session activities completed by the number of sessions delivered.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Salt Lake City, Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations