Obesity, ChildNCT07404839
Scaling up Building Healthy Families
A study testing Building Healthy Families Program in people with Obesity, Child, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Obesity, Child
- What is being tested?
- Building Healthy Families Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Grace Youn, (801) 581-7642, grace.youn@hsc.utah.edu
About this study
Official title: Scaling up Building Healthy Families in Rural Areas and Small Towns
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.
Read the detailed description
The investigators propose a community-level randomized controlled trial to determine the relative utility of providing an online training and resource package to support the planning, implementation, and sustainability of an evidence-based childhood obesity treatment intervention (EBI-CO), with and without participation in a systems-based action learning collaborative, to improve reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) in rural areas, small towns, or other low-resourced communities.
Twenty percent of the U.S. population lives in micropolitan (cities <50,000) and rural areas, where access to preventive health services and behavioral programs to address obesity is limited. Although EBI-COs exist, few have been translated into micropolitan and rural settings. A related issue is the potential mismatch between the resources and expertise used to deliver research- and hospital-based EBI-COs in urban areas and those available in micropolitan and rural areas. To address these issues, the investigators piloted the development and implementation of the Building Healthy Families (BHF) Online Training Resources and Program Package (BHF Program Resources), along with an implementation blueprint, to address childhood obesity in micropolitan and rural areas. The BHF Program Resources include an online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams.
The pilot study demonstrated that (1) a bundled fund, contract, and network-weaving strategy to increase BHF adoption successfully recruited micropolitan communities to deliver BHF, (2) a systems-based learning collaborative (BHF-LC) implementation strategy was feasible and showed potential for superior implementation fidelity and sustainability compared with receiving the BHF Resources Package Only (BHF-PO), (3) community implementation teams that participated in the BHF-LC reported more positive perceptions of contextual factors, facilitation, and BHF characteristics than those that did not, and (4) community implementation teams needed additional support related to program reach.
This trial proposes to expand the pilot into a fully powered hybrid Type 3 effectiveness-implementation, community-level RCT to test the utility of BHF-LC in improving BHF reach, effectiveness, implementation, and maintenance compared with communities receiving the BHF Resources Package Only (BHF-PO). The investigators will scale up the bundled adoption strategy to engage 30 micropolitan and rural communities. The research team will initiate community recruitment across the 6-state region served by the Huntsman Cancer Institute (Idaho, Montana, Nevada, New Mexico, Wyoming, Utah; see Letters of Support) and expand to rural, frontier, and other low-resourced settings in all states as needed. Communities will be randomly assigned to either the BHF-PO (n = 15) or the BHF-LC (n = 15) study condition to achieve the following aims:
Specific Aim 1: Determine whether community implementation teams (a) deliver BHF with higher implementation fidelity (primary outcome), (b) achieve higher reach, and (c) have an increased likelihood of sustainability based on assignment to BHF PO or BHF LC.
Specific Aim 2: Determine the effectiveness of BHF in reducing and maintaining child weight status based on community assignment to BHF LC versus BHF PO.
Specific Aim 3: Conduct a cost evaluation and cost-effectiveness analysis comparing communities that participate in the BHF LC to those that receive the BHF Program Resources (BHF PO) alone.
- Conditions
- Obesity, Child
- Being tested
- Building Healthy Families Program
- Keywords
- rural, implementation strategies, family based program, dissemination and implementation science, lifestyle change intervention, family based programs
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Healthy Families ProgramBehavioural
Also called BHF 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.
| Study group | Role | What they receive |
|---|---|---|
| Building Healthy Families (BHF) Program Resources Package Only (BHF-PO) | Active comparator | The BHF Program Resources include an online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams. Communities randomized to the BHF Program Resources Package Only (BHF-PO) study condition will have access to the online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams. Community-based implementation teams (CITs) will use the BHF Program Resources to train and deliver the BHF Program to families in their community. Receives: Behavioral: Building Healthy Families Program |
| Building Healthy Families Learning Collaborative (BHF-LC). | Experimental | Communities randomized to the BHF-LC study condition have access to BHF Program Resources and enhanced training through the learning collaborative facilitation strategy. Community Implementation Team (CIT) members in this study condition will participate in the learning collaborative, which consists of quarterly virtual learning sessions (8 total), over a two-year period. In between learning sessions, each BHF-LC CIT will have a 1-hour 1:1 action period meeting with the research team.
Community-based implementation teams (CITs) will use the BHF Program Resources to train and deliver the BHF Program to families in their community. Receives: Behavioral: Building Healthy Families Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Fidelity (community level)
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.
Measured: From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.
Secondary outcomes (2)
Change in child weight status
Child participant height, weight, age, and gender data recorded by CITs at baseline and 3 months will be used to calculate the change in weight status (i.e., BMI z-score).
Measured: 3 months
Costs
The cost of program adoption and implementation for communities will be tracked over the study using time-tracking methods to capture the time spent on program activities by implementation staff.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Nov 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type three effectiveness-implementation community-level randomized control trial in which communities will be recruited and assigned to one of two study conditions.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennie Hill, University of Utah
- Investigators
- Jennie Hill, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404839
- Sponsor's protocol ID
- 00188809
- Other IDs
- R01DK142843
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified raw and scored summary datasets for the primary outcome (implementation fidelity by site) and secondary outcome (effectiveness-child weight status) will be created for data analysis. Codebooks, programming code for data cleaning and storage, and preliminary and final output tables created during the analysis will also be stored. Family-level data from the BHF Resources are accessible only to the study team, and raw data or data with potential family or child-level identifiers cannot be shared. Deidentified summary data may be shared after all potentially revealing information is removed.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Building Healthy Families in Rural Areas and Small Towns
- ClinicalTrials.gov ID
- NCT07404839
- Acronym / sponsor ID
- 00188809
- Conditions
- Obesity, Child
- Keywords
- rural, implementation strategies, family based program, dissemination and implementation science, lifestyle change intervention, family based programs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose a community-level randomized controlled trial to determine the relative utility of providing an online training and resource package to support the planning, implementation, and sustainability of an evidence-based childhood obesity treatment intervention (EBI-CO), with and without participation in a systems-based action learning collaborative, to improve reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) in rural areas, small towns, or other low-resourced communities.
Twenty percent of the U.S. population lives in micropolitan (cities <50,000) and rural areas, where access to preventive health services and behavioral programs to address obesity is limited. Although EBI-COs exist, few have been translated into micropolitan and rural settings. A related issue is the potential mismatch between the resources and expertise used to deliver research- and hospital-based EBI-COs in urban areas and those available in micropolitan and rural areas. To address these issues, the investigators piloted the development and implementation of the Building Healthy Families (BHF) Online Training Resources and Program Package (BHF Program Resources), along with an implementation blueprint, to address childhood obesity in micropolitan and rural areas. The BHF Program Resources include an online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams.
The pilot study demonstrated that (1) a bundled fund, contract, and network-weaving strategy to increase BHF adoption successfully recruited micropolitan communities to deliver BHF, (2) a systems-based learning collaborative (BHF-LC) implementation strategy was feasible and showed potential for superior implementation fidelity and sustainability compared with receiving the BHF Resources Package Only (BHF-PO), (3) community implementation teams that participated in the BHF-LC reported more positive perceptions of contextual factors, facilitation, and BHF characteristics than those that did not, and (4) community implementation teams needed additional support related to program reach.
This trial proposes to expand the pilot into a fully powered hybrid Type 3 effectiveness-implementation, community-level RCT to test the utility of BHF-LC in improving BHF reach, effectiveness, implementation, and maintenance compared with communities receiving the BHF Resources Package Only (BHF-PO). The investigators will scale up the bundled adoption strategy to engage 30 micropolitan and rural communities. The research team will initiate community recruitment across the 6-state region served by the Huntsman Cancer Institute (Idaho, Montana, Nevada, New Mexico, Wyoming, Utah; see Letters of Support) and expand to rural, frontier, and other low-resourced settings in all states as needed. Communities will be randomly assigned to either the BHF-PO (n = 15) or the BHF-LC (n = 15) study condition to achieve the following aims:
Specific Aim 1: Determine whether community implementation teams (a) deliver BHF with higher implementation fidelity (primary outcome), (b) achieve higher reach, and (c) have an increased likelihood of sustainability based on assignment to BHF PO or BHF LC.
Specific Aim 2: Determine the effectiveness of BHF in reducing and maintaining child weight status based on community assignment to BHF LC versus BHF PO.
Specific Aim 3: Conduct a cost evaluation and cost-effectiveness analysis comparing communities that participate in the BHF LC to those that receive the BHF Program Resources (BHF PO) alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type three effectiveness-implementation community-level randomized control trial in which communities will be recruited and assigned to one of two study conditions.
| Arm | Type | Receives |
|---|---|---|
| Building Healthy Families (BHF) Program Resources Package Only (BHF-PO) | Active comparator | Behavioral: Building Healthy Families ProgramThe BHF Program Resources include an online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams. Communities randomized to the BHF Program Resources Package Only (BHF-PO) study condition will have access to the online train-the-trainer system, program materials, and a data portal for use by community-based implementation teams. Community-based implementation teams (CITs) will use the BHF Program Resources to train and deliver the BHF Program to families in their community. |
| Building Healthy Families Learning Collaborative (BHF-LC). | Experimental | Behavioral: Building Healthy Families ProgramCommunities randomized to the BHF-LC study condition have access to BHF Program Resources and enhanced training through the learning collaborative facilitation strategy. Community Implementation Team (CIT) members in this study condition will participate in the learning collaborative, which consists of quarterly virtual learning sessions (8 total), over a two-year period. In between learning sessions, each BHF-LC CIT will have a 1-hour 1:1 action period meeting with the research team. Community-based implementation teams (CITs) will use the BHF Program Resources to train and deliver the BHF Program to families in their community. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Healthy Families ProgramAlso: BHF ProgramBuilding 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. | Behavioural | Building Healthy Families (BHF) Program Resources Package Only (BHF-PO), Building Healthy Families Learning Collaborative (BHF-LC). |
Primary outcome
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.
2 secondary outcomes
Change in child weight status
Time frame: 3 months
Costs
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified raw and scored summary datasets for the primary outcome (implementation fidelity by site) and secondary outcome (effectiveness-child weight status) will be created for data analysis. Codebooks, programming code for data cleaning and storage, and preliminary and final output tables created during the analysis will also be stored. Family-level data from the BHF Resources are accessible only to the study team, and raw data or data with potential family or child-level identifiers cannot be shared. Deidentified summary data may be shared after all potentially revealing information is removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennie Hill, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Healthy Families Program in people with Obesity, Child, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BHF Program Coordinator (308.520.7580, bhf@nebraska.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Fidelity (community level) (time frame: From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.