Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk

NCT07147387 | Not Yet Recruiting

• 1 other identifier: STUDY00027631
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular (CV) Risk

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  percentage of eligible participants enrolled

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

• Implementation fidelity of program

  percentage of planned sessions delivered, based on facilitator checklists

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

• Participant adherence to program

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

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

• Recruitment rate of program

  percentage of eligible participants enrolled

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

• Bioelectrical Impedance Analysis (BIA)

  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.

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

Secondary Outcomes (8)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

(Control): Waitlist (Delayed Lion Hearts Program)

NO INTERVENTION

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.

Lion Hearts Physical Activity Program

EXPERIMENTAL

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.

Behavioral: Lion Hearts Family-Based Physical Activity Program

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.

Lion Hearts Physical Activity Program

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: Mother (or female caregiver) Any gender child
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

State College, Pennsylvania, 16802, United States

Location

Central Study Contacts

Janette Watkins M Dr, PhD

CONTACT

502-321-9683; jjw71102@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This study uses a two-arm, parallel-group design with a waitlist control. Mother-child dyads are allocated to either the immediate intervention group or a waitlist control group. The intervention group participates in a 12-week family-based physical activity program, delivered in community CrossFit affiliate settings. Sessions occur twice weekly and include functional strength and cardiovascular training, flexibility exercises, goal-setting, and family-oriented health education. The waitlist control group receives the same 12-week intervention following completion of all post-assessments. Both groups complete baseline, mid-intervention, post-intervention, and 3-month follow-up assessments to evaluate physical activity, health behaviors, cardiovascular fitness, and psychosocial outcomes. This design allows for evaluation of feasibility, acceptability, and preliminary effectiveness of the intervention while ensuring all participants have access to the program.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 29, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)