Scaling up Building Healthy Families

NCT07404839 | Active Not Recruiting

• 2 other identifiers: 00188809R01DK142843
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Child

Keywords

rural; implementation strategies; family based program; dissemination and implementation science; lifestyle change intervention; family based programs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in child weight status

  3 months

• Costs

  Up to 24 months

Study Arms (2)

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.

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.

Behavioral: Building Healthy Families Program

Interventions

Building Healthy Families Program BEHAVIORAL

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.

Also known as: BHF Program

Building Healthy Families (BHF) Program Resources Package Only (BHF-PO); Building Healthy Families Learning Collaborative (BHF-LC).

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennie Hill, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Hybrid type three effectiveness-implementation community-level randomized control trial in which communities will be recruited and assigned to one of two study conditions.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 12, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.

Locations

US (1)