Scaling up Building Healthy Families

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Obesity, Child

Treatments: Behavioral: Building Healthy Families Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07404839

00188809

R01DK142843 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Building Healthy Families (BHF) Program Resources Package Only (BHF-PO)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Building Healthy Families Program

Building Healthy Families Learning Collaborative (BHF-LC).

Experimental group

Description:

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.

Treatment:

Behavioral: Building Healthy Families Program