Lion Hearts: A Family Program for Cardiovascular Health
This study, called "Lion Hearts," is testing a 12-week family-based physical activity program to improve heart health in mothers and their children (ages 10-17). The program involves twice-weekly, 60-minute group exercise sessions at local CrossFit gyms. Researchers want to see if this program helps families become more physically active and if they enjoy and stick with the program. They will measure physical activity using FitBit devices and check how many families complete the program. You and your child must be able to safely do moderate-to-vigorous physical activity to join. This is a pilot study to see if the program is practical and effective before larger studies are done.
- Study design
- This is an interventional study with 100 planned participants. It is a pilot trial evaluating the feasibility, acceptability, and preliminary effectiveness of the Lion Hearts intervention.
- What's involved
- You and your child would participate in a 12-week program with twice-weekly, 60-minute group exercise sessions. You would also complete assessments at baseline, mid-intervention, post-intervention, and a 3-month follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for 3 months after the intervention ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
At a glance
Conditions
NCT07147387
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Penn State University
State College, Pennsylvaniastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Moderate-to-vigorous physical activity - FitBitBaseline (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 programImmediately post-intervention (within 1 week after completing the 12-week program).
percentage of eligible participants enrolled
- Implementation fidelity of programImmediately post-intervention (within 1 week after completing the 12-week program).
percentage of planned sessions delivered, based on facilitator checklists
- Participant adherence to programImmediately 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 programImmediately 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.