Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular (CV) Risk

• Registration Number: NCT07147387
• Lead Sponsor: Penn State University

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Moderate-to-vigorous physical activity - FitBit	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	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.
Retention rate of program	Immediately post-intervention (within 1 week after completing the 12-week program).	percentage of eligible participants enrolled
Implementation fidelity of program	Immediately post-intervention (within 1 week after completing the 12-week program).	percentage of planned sessions delivered, based on facilitator checklists
Participant adherence to program	Immediately post-intervention (within 1 week after completing the 12-week program).	percentage of study requirements completed, based on attendance logs and completion of assessments
Recruitment rate of program	Immediately post-intervention (within 1 week after completing the 12-week program).	percentage of eligible participants enrolled
Bioelectrical Impedance Analysis (BIA)	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	Bioelectrical Impedance Analysis (BIA) is a non-invasive method used to estimate body composition, including fat mass, lean body mass, and total body water. The technique works by sending a safe, low-level electrical current through the body and measuring the resistance (impedance) encountered by the current. Because lean tissue contains more water and conducts electricity better than fat tissue, impedance values can be used to calculate body composition using validated prediction equations.

Secondary Outcome Measures

Name	Time	Method
Barriers to Being Active Quiz	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	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").
Anxiety and Depression: Patient Health Questionnaire-4	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	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.
Social Support and Exercise Survey	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	The Social Support and Exercise Survey is a validated instrument developed to measure the degree of support individuals perceive from family and friends for engaging in physical activity. The survey includes items that assess two domains of support: participation/encouragement (e.g., exercising together, offering reminders) and rewards/punishments (e.g., criticism or discouragement). Respondents indicate how often specific supportive or unsupportive behaviors occurred during the past three months using a 5-point Likert scale ranging from 1 ("None") to 5 ("Very often").
Body Appreciation Scale-2 (BAS-2)	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	The Body Appreciation Scale-2 (BAS-2) is a validated self-report measure designed to assess positive body image. The 10-item questionnaire captures individuals' acceptance, respect, and appreciation of their bodies, as well as their ability to resist unrealistic appearance ideals promoted in society. Items are rated on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Always"), with total scores calculated as the mean of all items.
submaximal cycle ergometer test - cardiovascular fitness	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	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.
Exercise Regulations Questionnaire - BREQ-3	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	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.
Multidimensional Assessment of Interoceptive Awareness	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a validated self-report questionnaire designed to measure multiple dimensions of interoceptive body awareness. The MAIA assesses how individuals perceive, interpret, and respond to bodily sensations across eight subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Items are rated on a 6-point Likert scale from 0 ("Never") to 5 ("Always"), with higher scores indicating stronger interoceptive awareness in each domain.
Basic Psychological Needs Satisfaction and Frustration Scale	Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).	The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) is a validated self-report instrument grounded in Self-Determination Theory. It assesses the extent to which individuals experience satisfaction and frustration of the three universal psychological needs: autonomy (feeling a sense of choice and control), competence (feeling effective and capable), and relatedness (feeling connected to others). The scale includes parallel subscales for both satisfaction and frustration, with items rated on a 5-point Likert scale ranging from 1 ("Not true at all") to 5 ("Completely true").

Trial Locations

Locations (1)

Penn State University; 🇺🇸 State College, Pennsylvania, United States