Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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+)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: (Control): Waitlist (Delayed Lion Hearts Program)No intervention 0 interventions
Group B: Lion Hearts Physical Activity ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Moderate-to-vigorous physical activity - FitBit

Physical activity behavior will be assessed using Fitbit wearable activity monitors for 7 days pre-intervention and 7 days post-intervention. Fitbits use accelerometry and heart rate sensors to estimate daily time spent in different intensity categories. The primary outcome will be minutes of moderate-to-vigorous physical activity (MVPA) per day, derived from Fitbit activity intensity classifications. Secondary measures include total step counts and sedentary time.

Time frame
Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).
2

Retention rate of program

percentage of eligible participants enrolled

Time frame
Immediately post-intervention (within 1 week after completing the 12-week program).
3

Implementation fidelity of program

percentage of planned sessions delivered, based on facilitator checklists

Time frame
Immediately post-intervention (within 1 week after completing the 12-week program).
4

Participant adherence to program

percentage of study requirements completed, based on attendance logs and completion of assessments

Time frame
Immediately post-intervention (within 1 week after completing the 12-week program).

Secondary outcomes

1

submaximal cycle ergometer test - cardiovascular fitness

Aerobic capacity will be assessed using a submaximal cycle ergometer test. Participants complete a graded exercise protocol on a stationary bicycle, during which workload and heart rate responses are recorded. Using validated prediction equations, these data are used to estimate maximal oxygen uptake (VO₂ max), a gold-standard indicator of cardiorespiratory fitness.

Time frame
Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).
2

Exercise Regulations Questionnaire - BREQ-3

The Exercise Regulations Questionnaire (BREQ-3) is a validated self-report instrument designed to assess behavioral regulations for exercise based on Self-Determination Theory. The BREQ-3 measures the degree to which individuals are motivated to engage in physical activity across a continuum from amotivation to intrinsic motivation. The 24-item questionnaire includes six subscales: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation. Each item is scored on a 5-point Likert scale ranging from 0 ("Not true for me") to 4 ("Very true for me"). Subscale scores are calculated as the mean of relevant items, and higher scores indicate stronger endorsement of that form of regulation.

Time frame
Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).
3

Barriers to Being Active Quiz

The Barriers to Being Active Quiz is a standardized instrument developed by the Centers for Disease Control and Prevention (CDC) to identify perceived barriers that may prevent individuals from engaging in regular physical activity. The 21-item questionnaire assesses seven categories of barriers: lack of time, social influence, lack of energy, lack of willpower, fear of injury, lack of skill, and lack of resources. Each category is represented by three items, and responses are scored on a 4-point Likert scale ranging from 0 ("Very unlikely") to 3 ("Very likely").

Time frame
Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).
4

Anxiety and Depression: Patient Health Questionnaire-4

The Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief screening tool designed to assess core symptoms of anxiety and depression. It combines the two-item Generalized Anxiety Disorder scale (GAD-2) and the two-item Patient Health Questionnaire depression scale (PHQ-2) into a four-item measure. Each item is rated on a 4-point Likert scale from 0 ("Not at all") to 3 ("Nearly every day"), with total scores ranging from 0 to 12.

Time frame
Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).

Other outcomes

Sponsors and contacts

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