Scaling up Building Healthy Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Building Healthy Families Program.
- Who it may be relevant to
- Registry conditions: Obesity, Child. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Scaling up Building Healthy Families in Rural Areas and Small Towns
Overview
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.
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
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.]
Secondary outcome measures (2)
- Change in child weight status [Time frame: 3 months]
- Costs [Time frame: Up to 24 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Utah — Salt Lake City
Identifiers
NCT: NCT07404839 · 00188809 · R01DK142843