Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lion Hearts Family-Based Physical Activity Program.
- Who it may be relevant to
- Registry conditions: Cardiovascular (CV) Risk. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- 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).]
- Retention rate of program [Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Implementation fidelity of program [Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Participant adherence to program [Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Recruitment rate of program [Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Bioelectrical Impedance Analysis (BIA) [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
Secondary outcome measures (8)
- submaximal cycle ergometer test - cardiovascular fitness [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Exercise Regulations Questionnaire - BREQ-3 [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Barriers to Being Active Quiz [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Anxiety and Depression: Patient Health Questionnaire-4 [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Social Support and Exercise Survey [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Body Appreciation Scale-2 (BAS-2) [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Multidimensional Assessment of Interoceptive Awareness [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
- Basic Psychological Needs Satisfaction and Frustration Scale [Time frame: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
Eligibility criteria
Inclusion criteria
- Mother-child dyad willing to participate together in the full 12-week intervention and assessment activities
- Child aged 10-17 years old
- Mother (or female caregiver)
- Both mother and child must be able to safely engage in moderate-to-vigorous physical activity, as determined by pre-participation health screening (e.g., PAR-Q+)
- Access to transportation to attend twice-weekly exercise sessions at a local CrossFit affiliate
Exclusion criteria
- Presence of a medical condition that would make participation in moderate-to-vigorous physical activity unsafe, as determined by health screening or medical provider (e.g., uncontrolled hypertension, cardiovascular disease, severe orthopedic limitations)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Penn State University — State College
Identifiers
NCT: NCT07147387 · STUDY00027631