Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

Part of paid clinical trials in State College, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT07147387
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular (CV) Risk

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lion Hearts Family-Based Physical Activity Program — BEHAVIORAL
    The Lion Hearts Family-Based Physical Activity Program is a 12-week, community-based intervention designed to improve cardiovascular health and physical activity behaviors among mother-child dyads. The program consists of twice-weekly, 60-minute group exercise sessions delivered at local CrossFit affiliates. Each session includes scalable functional movement exercises, strength training, cardiovascular conditioning, and flexibility activities appropriate for both adults and children. In addition to physical activity, sessions incorporate goal-setting, family teamwork activities, and health education components to promote sustainable behavior change. The program was co-designed with community members during earlier study phases and is tailored to support engagement, feasibility, and family bonding.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: (Control): Waitlist (Delayed Lion Hearts Program)
    Participants in this group will serve as a waitlist control and will not receive the intervention during the initial study period. They will continue with their usual activities and will be offered the Lion Hearts program after the completion of the trial.
  • Experimental: Lion Hearts Physical Activity Program
    Participants in this group will take part in Lion Hearts, a community-based physical activity program delivered in partnership with local CrossFit affiliates. The program uses high-intensity functional training (HIFT) and family-based co-design strategies to promote cardiovascular health and increase moderate-to-vigorous physical activity among mothers and their children.

Primary Outcome Measure

Moderate-to-vigorous physical activity - FitBit [ Time Frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State UniversityState CollegePennsylvania16802
Janette Watkins Dr
[email protected]
502-321-9683

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By research site
Penn State University· State College, PA

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