Mountain West Prevention Research Center Core Research Project

The researchers propose a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (HEI-SMART) to determine the impact of integrating population health management (PHM) via text messaging and direct enrollment in Building Healthy Families (BHF) for lower-income families with a child aged 5-12 years with obesity identified through clinical partner (community health clinics, pediatric clinics, rural hospitals) electronic health record data. The sequential randomization design focuses on both initial recruitment (primary outcome) and retention in BHF sessions by randomly assigning enrolled families to text-only or text plus motivational retention messages.

BHF is a community-delivered evidence-based intervention to prevent and treat childhood obesity. The intervention educates families about healthy eating, physical activity, and healthy habits and facilitates goal setting and self-monitoring to improve lifestyle behaviors and manage weight. BHF includes a standard program evaluation conducted by community-based organizations (CBOs) to support quality improvement. The initial procedures describe activities undertaken by the research team to facilitate BHF delivery.

Identifying Community Partners An interdisciplinary network across the Mountain West region will provide infrastructure for applied research addressing obesity-related disparities among low-income families in rural and micropolitan communities in Idaho, Montana, Nevada, Utah, Wyoming, and surrounding states. This network will identify clinical organizations and CBOs to partner in identifying eligible patients and delivering BHF.

Clinical Organizations Participating clinical organizations will complete data-sharing agreements enabling PHM strategies to identify eligible children and caregivers through EHRs and conduct outreach via text messaging. Agreements permit study procedures to be conducted by the University of Utah research team, reducing burden on clinical partners.

The PHM strategy:

• Interfaces EHRs with a centralized cloud-based data warehouse
• Enables rapid cohort identification and messaging campaigns with patient-level randomization and bilingual messaging
• Supports bidirectional text messaging with single-touch response
• Provides a web-based dashboard for monitoring responses and supporting outreach The system is designed for potential use by other organizations with records of eligible families.

Community-Based Organizations CBO partners in corresponding geographic areas will deliver BHF. Enrolled families will be connected to local CBO programs. Data-sharing agreements will allow access to de-identified program evaluation data for secondary analysis.

Up to eight communities will be enrolled, adding two every six months beginning late in Year 1, through a standardized Request for Applications (RFA) process. Informational webinars disseminated through regional networks will describe BHF and application procedures. Communities will be selected based on:

• Demonstrated local need
• Capacity to deliver BHF
• Sustainability plans
• Likelihood of successful recruitment and implementation

Communities lacking required partnerships may apply for a partnership development award ($3,000) to build clinical collaborations, followed by a brief report and Organizational Readiness for Change survey after six months.

Community Implementation Teams Each CBO will establish a Community Implementation Team (CIT) including program, nutrition, physical activity, and lifestyle coordinators plus volunteers. Team composition is determined locally.

CIT members will receive access to the online BHF program platform and will complete electronic consent for evaluation activities including surveys, interviews, learning collaborative participation, lightning reports, and direct observations. BHF delivery follows the existing packaged intervention without modification.

Semi-Annual Surveys Surveys assessing training resources, facilitation, and context will be completed every six months beginning shortly after program access and continuing through six months after completion of a second cohort.

Program Package Engagement The package includes materials, training modules, knowledge checks, fidelity assessments, and a data portal, as well as screening for social needs. The Action Learning Collaborative will support development of community-specific plans addressing social determinants of health, particularly food insecurity.

Knowledge checks and fidelity assessments are embedded within the program, with de-identified aggregated data available to the research team.

Time Tracking CIT members will track activities associated with dissemination and implementation strategies using a web- or app-based system.

BHF Action Learning Collaborative CITs will participate in quarterly learning sessions and action periods following Plan-Do-Study-Act cycles addressing recruitment, readiness, engagement, implementation quality, sustainability, effectiveness, maintenance, social determinants of health, and coordination with clinical partners. Activities include synchronous sessions, on-demand support, and mid-quarter lightning reports to review progress and address barriers. Rapid qualitative analysis will inform action plans returned to CITs for ongoing improvement.

Sessions and technical interactions will be recorded, transcribed, and analyzed.

Direct Observations Observers will attend BHF sessions (1-18 per community) to assess fidelity using standardized checklists, attendance counts, and documentation of adaptations. Observers will minimize interaction and clarify that observations evaluate program delivery rather than individual performance.

Key Informant Interviews Semi-structured interviews with CIT members will assess strategies affecting RE-AIM outcomes and i-PARIHS constructs, including innovation characteristics, recipient factors, facilitation, and contextual influences.

Recruitment Procedures Text messaging content will be developed through iterative user-centered design with caregivers and community partners to ensure cultural and regional appropriateness and reduce stigma.

Participating clinical organizations will identify eligible families (child aged 5-12 years with BMI ≥85th percentile, recent clinical encounter, valid contact information, and permission for text contact). Families will receive mailed study information with multiple opt-out options including postcard, QR code form, telephone, or email.

Families not opting out within two weeks will be randomized to one of four outreach conditions:

• Single text invitation
• Single text plus active outreach
• Repeated texts over six months
• Repeated texts plus active outreach Messages will be bidirectional with one-touch response and enrollment links. Active outreach will consist of telephone contact from local CIT members.

Family Participation Interested families will enroll in BHF through local CBOs and complete orientation, consent, and baseline assessments including anthropometric measures, behavioral factors, and social determinants of health. Data will be stored in the BHF program portal.

Families will attend weekly two-hour group sessions for 12 weeks followed by ongoing sessions up to one year. Attendance, body weight, physical activity, nutrition, and self-monitoring will be recorded. Individual-level data will be obtained at 3, 6, and 12 months.

As part of the sequential design, enrolled families will be randomized to:

• Standard reminder texts
• Reminder texts plus motivational and skill-building messages Enhanced messages will target social cognitive theory constructs such as outcome expectations and self-efficacy and will align with session topics.

Resource Connection CITs will identify and connect families with community resources based on screening for needs, particularly food insecurity, using established guidance such as the PRAPARE toolkit. Strategies may include assistance with school meal programs, SNAP eligibility, and local food support services.

Each CBO will implement two cohorts over two years.

Outcomes The primary outcome is reach, defined as the proportion of interested families completing the BHF orientation session. Primary hypotheses compare recruitment effectiveness between single versus repeated text outreach.

Secondary outcomes include:

• Session attendance at 12 months
• Changes in child BMI-z scores
• Changes in parent or caregiver weight
• Adoption (number and proportion of communities delivering BHF)
• Implementation (proportion of activities completed by CITs)
• Maintenance (initiation of a third cohort)

Inclusion criteria

Families

Parent or legal caregiver and at least one child aged 5 to 12 years

Child identified through electronic health record data from a participating clinical organization

Child has had at least one clinical encounter at the participating site within the past 12 months

Child has body mass index (BMI) at or above the 85th percentile for age and sex

Caregiver has not opted out of receiving text communication from the clinic

Valid mailing address and telephone number listed in the electronic health record

Parents and/or Caregivers

Parent or legal caregiver of an eligible child

Responsible for the child's care and able to provide consent for program participation

Children

Aged 5 to 12 years at time of identification

Meet all criteria listed above

Exclusion criteria

Child has a medical condition or contraindication that precludes participation in moderate physical activity

Child has severe cognitive or physical impairment that would prevent participation in the intervention

Child or family is currently participating in another structured weight management or obesity treatment program

Family opts out of receiving study-related communications