About this trial
This hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial will assess the impact of integrating population health management (PHM) strategies-text messaging and enrollment in Building Healthy Families (BHF)-for lower-income families with a child with obesity identified through electronic health record (EHR) data. BHF promotes family healthy eating, physical activity, and lifestyle behavior strategies to manage weight. The research team will partner with clinical sites (community health clinics, pediatric clinics, rural hospitals) and Community-Based Organizations (CBOs). Clinical partners will execute data-sharing agreements enabling the research team to identify eligible children and caregivers and conduct outreach via text messaging. CBO partners will deliver BHF and provide de-identified data for program evaluation. Community Implementation Teams (CITs) will complete training, surveys, interviews, learning collaborative activities, fidelity assessments, and time tracking as part of quality improvement. The BHF Action Learning Collaborative will use quarterly sessions and Plan-Do-Study-Act cycles to address recruitment, implementation, sustainability, social determinants of health, and team coordination. The research team will record sessions, conduct direct observations of BHF delivery, and take field notes to assess fidelity and adaptations. Families will be identified through EHR records and mailed a consent and authorization cover letter, postcard, QR code, and intervention information with opt-out options. Those who do not opt out will be randomized to bidirectional text messaging with one-touch response and enrollment opportunities, with or without active outreach (telephone or text) from the local CIT. Enrolled families will complete orientation, baseline assessment, and weekly group sessions with ongoing follow-up. Attendance, body weight, goals, and self-monitoring will be recorded in a CIT data portal. Families will be randomized to receive either simple text reminders or reminders with motivational and skill-building prompts matched to session topics. CITs will also connect families to food assistance programs and local resources. Each CIT will complete two cohorts over two years. The primary outcome is reach; secondary outcomes include session attendance, changes in child BMI-z scores, changes in parent or caregiver weight, and changes in adoption, implementation, and maintenance at the community level.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Text Message-based recruitment
BehavioralText messaging (TM) outreach delivered by the research team using bidirectional text messages sent to caregivers of eligible children identified through participating clinical organizations. Messages include a one-touch response option and a direct link to enroll in Building Healthy Families. Text messaging allows caregivers to respond directly to the community implementation team to express interest in enrollment. Participants may opt out of receiving messages at any time. Depending on the assigned study condition, participants may receive either a single outreach message or repeated outreach messages over a 3-month period.
Active outreach follow-up
BehavioralActive outreach (AO) consists of telephone or other follow-up contact with caregivers conducted by members of the local Community Implementation Team (CIT). During the call, CIT members provide information about the BHF, answer questions, and offer assistance with enrollment. Outreach scripts and approaches are adapted to the local community context to support engagement with eligible families. Active outreach represents a standard recruitment activity used by community partners to encourage participation in the program.
Treatment groups
Trial outcomes
Primary outcomes
Reach: Enrollment in the Building Healthy Families Program
Reach is defined as the proportion of eligible families who enroll in the Building Healthy Families program following outreach through population health management strategies. Enrollment is operationalized as completion of the BHF orientation session after responding to text messaging and/or active outreach recruitment strategies. Reach will be compared across randomized recruitment strategies that vary by text message frequency (single vs repeated outreach) and the presence or absence of active telephone outreach from the Community Implementation Team.
Program Attendance (Participant Retention)
Attendance is defined as the proportion of scheduled BHF sessions attended by enrolled families during the program delivery period. Attendance data will be captured through the BHF program data portal and reflects ongoing engagement with the intervention following enrollment.
Secondary outcomes
Child BMI z-score
Change in child BMI z-score measured from baseline to follow-up using anthropometric measurements collected during BHF program evaluation. BMI z-scores will be calculated based on standardized CDC growth charts for children.
Change in parent/caregiver weight
Change in parent or caregiver body weight measured from baseline to follow-up as part of the BHF program evaluation. Weight is collected during program sessions and recorded in the BHF data portal.
Number of Communities Adopting Building Healthy Families
Adoption is defined as the number and proportion of rural and micropolitan communities that agree to implement and initiate delivery of the BHF program following the partnership development grant and request for applications process.
Direct observation of Implementation fidelity
Implementation fidelity is defined as the proportion of required program activities completed during BHF sessions as reported by Community Implementation Team members and assessed using session fidelity checklists embedded in the BHF program package.
Sponsors and contacts
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Paul Estabrooks
Lead sponsor
University of Utah
Sponsor institution