Mountain West Prevention Research Center Core Research Project

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Paul Estabrooks
Study ID
NCT07479498
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Mar 2026
Primary completion
Sep 29, 2029
Completion
Sep 29, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Reach: Enrollment in the Building Healthy Families Program [ Time Frame: Up to 3 months after initial outreach ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of UtahSalt Lake CityUtah84112
Madeleine L French, MS
[email protected]
6166175034

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The University of Utah· Salt Lake City, UT

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