NCT07147387

Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Lion Hearts study is a three-phase, community-based research project designed to reduce multigenerational cardiovascular disease (CVD) risk through a family-centered physical activity intervention. This record describes Phase 3, a pilot trial evaluating the feasibility, acceptability, and preliminary effectiveness of the Lion Hearts intervention among mother-child dyads. The intervention was co-designed during Phase 2 using implementation mapping with mothers, children, certified fitness professionals, and community stakeholders. In Phase 3, the refined intervention will be delivered over 12 weeks in community fitness settings, specifically local CrossFit affiliates. The program consists of twice-weekly, 60-minute family fitness sessions, which include functional strength and cardiovascular exercises scaled appropriately for adults and children. Sessions also integrate components of goal setting, teamwork, and health education to foster family bonding and promote sustainable behavior change. Participants will complete comprehensive assessments at four time points: baseline (Weeks 1-2), mid-intervention (Week 6), post-intervention (Weeks 13-14), and 3-month follow-up. Assessments include: Surveys measuring physical activity, health behaviors, quality of life, and family functioning Fitness assessments (e.g., cardiovascular endurance, strength, flexibility) Physical health markers (e.g., height, weight, waist circumference, blood pressure) 7-day physical activity monitoring using accelerometers Optional laboratory bloodwork (e.g., lipid profiles, glucose levels) Semi-structured interviews and focus groups to evaluate participant experience and program acceptability The pilot trial will assess key implementation outcomes (feasibility, fidelity, satisfaction, and attendance), as well as preliminary signals of effectiveness on physical activity behavior, cardiovascular health, and psychosocial outcomes. The findings will guide further adaptation and inform the design of a larger randomized controlled trial.

Conditions

• Cardiovascular (CV) Risk

Interventions

Type	Name	Description
BEHAVIORAL	Lion Hearts Family-Based Physical Activity Program	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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2025-08-29
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States