NCT07479498 · Paul Estabrooks
Mountain West Prevention Research Center Core Research Project
(MW-PRCCRP)
What this study is about
This hybrid type 3 effectiveness-implementation sequential multiple assignment randomly assigned 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Reach: Enrollment in the Building Healthy Families Program
Time frame: Up to 3 months after initial outreach
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.
Program Attendance (Participant Retention)
Time frame: 12 months after enrollment
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations