Recruiting

BHF & PHM

Sponsor:

Paul Estabrooks

Code:

NCT07479498

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Text Message-based recruitment

Active outreach follow-up

Study Details

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

Study ID

NCT07479498

Start date

Sep 30, 2024

Status verified date

Mar, 2026

Completion date

Sep 29, 2029

Anticipated

Primary completion date

Sep 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

  • Reach: Enrollment in the Building Healthy Families Program [ Time Frame: Up to 3 months after initial outreach ]
  • Program Attendance (Participant Retention) [ Time Frame: 12 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

More Information

Sponsor

Paul Estabrooks

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Paul Estabrooks on 2026-03-18.