Clinical Trial

Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-21.
Trial Details
NCT Number NCT07147387
Lead Sponsor Penn State University
Conditions Cardiovascular (CV) Risk
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-02