Scaling up Building Healthy Families
ConditionObesity, Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Building Healthy Families Program
BehavioralBuilding 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Building Healthy Families (BHF) Program Resources Package Only (BHF-PO)Active comparator 1 intervention
Group B: Building Healthy Families Learning Collaborative (BHF-LC).Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
From BHF session initiation to the end of sessions (~ 12 months) for one cohort in each enrolled community.Secondary outcomes
1
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).
Time frame
3 months2
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.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov