Mountain West Prevention Research Center Core Research Project (MW-PRCCRP)

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Text Message-based recruitment; Behavioral: Active outreach follow-up

Detailed Description

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:

1. Interfaces EHRs with a centralized cloud-based data warehouse
2. Enables rapid cohort identification and messaging campaigns with patient-level randomization and bilingual messaging
3. Supports bidirectional text messaging with single-touch response
4. 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)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeleine L French, MS; Phone Number: 6166175034; Email: madeleine.french@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • The University of Utah
      • Contact: Madeleine L French, MS; Phone Number: 6166175034; Email: madeleine.french@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TM-Single; Participants receive a single bidirectional text message from the research team with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program.	Behavioral: Text Message-based recruitment; Text 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.
Experimental: TM-Single-AO; Participants receive a single bidirectional text message from the research team with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team.	Behavioral: Text Message-based recruitment; Text 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.; Behavioral: Active outreach follow-up; Active 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.
Experimental: TM-Repeat; Participants receive repeated bidirectional text messages from the research team over a 3-month period, with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program. Participants may opt out of receiving messages at any time.	Behavioral: Text Message-based recruitment; Text 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.
Experimental: TM-Repeat-AO; Participants receive repeated bidirectional text messages from the research team over a 3-month period, with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team. Participants may opt out of receiving messages at any time.	Behavioral: Text Message-based recruitment; Text 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.; Behavioral: Active outreach follow-up; Active 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months after initial outreach
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.	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months, and 12 months after enrollment.
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.	Baseline, 3 months, and 12 months after enrollment
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.	Up to 4 years
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.	Up to 12 months after program initiation
Number of Communities Maintaining BHF delivery	Maintenance is defined as the continued delivery of BHF beyond the initial cohort of families, operationalized as the initiation of a second or third cohort of BHF participants by a community implementation team.	Up to 24 months after program initiation.

Collaborators and Investigators

• Sponsor: Paul Estabrooks
• Investigators: Principal Investigator: Paul A Estabrooks, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Engagement; Rural; Population Health Management; Reach; Family Healthy Weight Program
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: U48DP006789 (U.S. NIH Grant/Contract); 1 U48DP006789-01-00 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified, scored datasets for the primary outcome (reach) and secondary outcomes will be made available at the time of peer review publication and will be open access for 7 years following the end of the trial period.
• IPD Sharing Time Frame: 6/1/2030 to 5/30/2037
• IPD Sharing Access Criteria: De-identified individual participant data (IPD) and supporting documentation will be available to qualified researchers who provide a methodologically sound research proposal that is approved by the study investigators and the relevant institutional review board or ethics committee, as applicable. Available materials will include the analytic dataset underlying published results, data dictionary, study protocol, statistical analysis plan, and analytic code. Access will be provided through a controlled process following execution of a data use agreement that specifies conditions for data security, confidentiality, and appropriate use. Requests for access should be directed to the study team through the contact information provided in the trial record.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No