Primary care program to improve children's lifelong heart health
Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial
This project tests whether adding text messages and clinician fidelity support to the Family Check‑Up 4 Health program in primary care helps children with BMI at or above the 85th percentile improve health behaviors and lower BMI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06526312 on ClinicalTrials.gov |
What this trial studies
This is a hybrid type 3 cluster-randomized factorial implementation trial that focuses on testing implementation strategies for the Family Check‑Up 4 Health (FCU4Health) program in primary care. About 900–1,200 families receiving care at Denova Integrated Healthcare will all get FCU4Health services while care teams (11–12 clusters) are randomized to combinations of SMS engagement and fidelity monitoring tools (Lyssn and COACH). The protocol integrates these technology supports with the electronic health record and collects parent/caregiver and child measures at baseline, 6, 12, and 18 months to track fidelity, engagement, and child health behaviors. Secondary work includes cost-effectiveness analyses and examining links between behavior change trajectories and BMI across age, race/ethnicity, language, and gender subgroups.
Who should consider this trial
Good fit: Ideal candidates are families receiving care at Denova Integrated Healthcare with children aged 2–17 who have a BMI at or above the 85th percentile for age and sex.
Not a fit: Families whose children have BMI below the 85th percentile, who are not patients at Denova, or who cannot engage with the in-person or digital components may be unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the approach could boost family engagement, improve parenting around health behaviors, and reduce child BMI and future cardiovascular risk at scale.
How similar studies have performed: Previous randomized trials of the Family Check‑Up have shown improvements in parenting and child health behaviors and some BMI effects, though combining EHR-integrated text messaging and Lyssn fidelity support in primary care is a newer approach with limited prior implementation data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI at or above 85 percentile for age and gender. Exclusion Criteria: * N/A
Where this trial is running
Phoenix, Arizona
- Denova Integrated Healthcare — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Cady Berkel, Ph.D. — Arizona State University
- Study coordinator: Michele M Porter, Ph.D.
- Email: michele.porter@asu.edu
- Phone: 4802037550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.