Mountain West Prevention Research Center Core Research Project

NCT07479498 | Recruiting DMC

• 2 other identifiers: U48DP0067891 U48DP006789-01-00
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity

Keywords

Family Healthy Weight Program; Population Health Management; Rural; Reach; Engagement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Child BMI z-score

  Baseline, 3 months, and 12 months after enrollment.

• Change in parent/caregiver weight

  Baseline, 3 months, and 12 months after enrollment

• Number of Communities Adopting Building Healthy Families

  Up to 4 years

• Direct observation of Implementation fidelity

  Up to 12 months after program initiation

• Number of Communities Maintaining BHF delivery

  Up to 24 months after program initiation.

Study Arms (4)

TM-Single

EXPERIMENTAL

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

TM-Single-AO

EXPERIMENTAL

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; Behavioral: Active outreach follow-up

TM-Repeat

EXPERIMENTAL

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

TM-Repeat-AO

EXPERIMENTAL

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; Behavioral: Active outreach follow-up

Interventions

Text Message-based recruitment BEHAVIORAL

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.

TM-Repeat; TM-Repeat-AO; TM-Single; TM-Single-AO

Active outreach follow-up BEHAVIORAL

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.

TM-Repeat-AO; TM-Single-AO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Estabrooks: lead

Study Sites (1)

The University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul A Estabrooks, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine L French, MS

CONTACT

6166175034; madeleine.french@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean of Community Engagement, College of Health and Professor in the Department of Health & Kinesiology

Model Details: This hybrid type 3 effectiveness-implementation, sequential multiple assignment randomized trial (HEI-SMART) will test the impact of integrating PHM via text messaging and direct enrollment in Building Healthy Families (BHF) for lower-income families with a child (6-12 years) who has obesity, identified through community health center electronic health record data.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 18, 2026
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 6/1/2030 to 5/30/2037
• 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.

Locations

US (1)