NCT07479498 Mountain West Prevention Research Center Core Research Project
| NCT ID | NCT07479498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paul Estabrooks |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2029-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-09-30 with a primary completion date of 2029-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Paul A Estabrooks, PhD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT07479498 clinical trial?
This trial is open to participants of all sexes, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479498 currently recruiting?
Yes, NCT07479498 is actively recruiting participants. Contact the research team at madeleine.french@utah.edu for enrollment information.
Where is the NCT07479498 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07479498 clinical trial?
NCT07479498 is sponsored by Paul Estabrooks. The principal investigator is Paul A Estabrooks, PhD at University of Utah. The trial plans to enroll 600 participants.
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