Scaling up Building Healthy Families

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Child
• Intervention / Treatment: Behavioral: Building Healthy Families Program

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Building Healthy Families (BHF) Program Resources Package Only (BHF-PO); 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.	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.; Other Names: BHF Program
Experimental: Building Healthy Families Learning Collaborative (BHF-LC).; 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.	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.; Other Names: BHF Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jennie Hill, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rural; implementation strategies; family based program; dissemination and implementation science; lifestyle change intervention; family based programs
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 00188809; R01DK142843 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Deidentified scored datasets for the primary outcome (implementation fidelity by site) will be available at the time of peer review publication and will be available open access for seven years following the end of the trial period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No