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Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Start date changed from estimate of Aug 1, 2026 to Oct 1, 2026 · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 8 of 8 entries · 1 more Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site contact updated
  2. Start date: Sep 1, 2025 to Aug 1, 2026 Primary completion date: Dec 1, 2026 to May 1, 2027 · Completion date: Apr 1, 2027 to Dec 1, 2027v2 Show 2 more changesShow less
    • Primary completion date: Dec 1, 2026 to May 1, 2027
    • Completion date: Apr 1, 2027 to Dec 1, 2027
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of Lion Hearts, a community-based, family-centered physical activity intervention designed to improve cardiovascular health among mother-child dyads. Developed through community co-design, the 12-week intervention is delivered in local CrossFit affiliates and includes twice-weekly fitness sessions incorporating functional movement, goal setting, teamwork, and health education. The study aims to assess changes in physical activity, fitness, and cardiovascular health markers, as well as family dynamics and motivation for physical activity. Participants complete baseline, mid-, post-, and 3-month follow-up assessments, including surveys, fitness testing, accelerometry, and optional lab work. Findings will inform the refinement of the intervention for future large-scale trials.
Trial Details
NCT Number NCT07147387
Lead Sponsor Penn State University
Conditions Cardiovascular (CV) Risk
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov