Primary care program to improve children's lifelong heart health
Official title: Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial
Run by Arizona State University · NCT06526312 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | July 5, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT06526312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI at or above 85 percentile for age and gender. Exclusion Criteria: * N/A
Where it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.