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Primary Care Evidence-based Approach for Improving Lifelong Health

Study acronym: PREVAIL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 52% 840 → 400 participants
See other at-risk trials from Arizona State University

Record History

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  1. Enrollment reduced: 840 → 400 participantsv7 Show 4 more changesShow less
    • Primary and study completion dates: Jul 2028 to Jul 31, 2028
    • Start date: Jun 9, 2025 to Jul 5, 2025
    • Secondary endpoints: details revised at 16 of 18 entries
    • Study description shortened, about 2 words
  2. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Enrollment target: 1200 to 840
    • Start date changed from estimate of Jun 30, 2025 to Jun 9, 2025
    • Interventions: Family Check-Up 4 Health (FCU4Health) (Behavioral), Fidelity Monitoring System (Lyssn) (Behavioral), SMS/Text (CAMPI) (Behavioral) to Family Check-Up 4 Health (FCU4Health) (Behavioral), Fidelity Monitoring (Lyssn and COACH) (Behavioral), SMS/Text (CAMPI) (Behavioral)
    • Site details revised
  3. Start date: Apr 1, 2025 to Jun 30, 2025v5
  4. Start date: Feb 1, 2025 to Apr 1, 2025v4
  5. Start date: Sep 15, 2024 to Feb 1, 2025v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing cardiovascular disease risk in children. Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records, the study aims to enhance intervention fidelity and engagement. Results will inform scalable approaches to promote child and family health behaviors, improve parenting skills, and potentially reduce child BMI, contributing to significant public health impacts in addressing cardiovascular health disparities.
Trial Details
NCT Number NCT06526312
Lead Sponsor Arizona State University
Collaborators: Northwestern University, University of Oregon, University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Clinical Trial
Related terms Health Behavior
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov