Cardiovascular (CV) RiskNCT07147387
Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
A study testing Lion Hearts Family-Based Physical Activity Program in people with Cardiovascular (CV) Risk, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk
- What is being tested?
- Lion Hearts Family-Based Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Penn State University
State College, Pennsylvania, 16802
About this study
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.
Read the 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.
- Conditions
- Cardiovascular (CV) Risk
- Being tested
- Lion Hearts Family-Based Physical Activity Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lion Hearts Family-Based Physical Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| (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. Receives: Behavioral: Lion Hearts Family-Based Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately post-intervention (within 1 week after completing the 12-week program).
Recruitment rate of program
percentage of eligible participants enrolled
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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").
Measured: 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
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.
Measured: 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
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").
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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").
Measured: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Oct 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janette Watkins, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147387
- Sponsor's protocol ID
- STUDY00027631
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small-scale pilot feasibility trial, and the dataset is not sufficiently powered or generalizable for meaningful secondary analyses. In addition, the dataset contains sensitive family- and health-related information, which poses a risk of re-identification even with standard de-identification procedures.
Publications
Watkins J, Goss J, Mehls K, Marshall A, Dlugonski D, Downs DS. Lion Hearts: applying implementation mapping to plan the delivery of a family-based physical activity intervention in community CrossFit affiliates. Front Public Health. 2026 Oct 6;14:1970725. doi: 10.3389/fpubh.2026.1970725. eCollection 2026.
PubMed 42903273
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT07147387
- Acronym / sponsor ID
- STUDY00027631
- Conditions
- Cardiovascular (CV) Risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| (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 | Behavioral: Lion Hearts Family-Based Physical Activity ProgramParticipants 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lion Hearts Family-Based Physical Activity ProgramThe 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. | Behavioural | Lion Hearts Physical Activity Program |
Primary outcome
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).
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
Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).
percentage of eligible participants enrolled
Implementation fidelity of program
Time frame: 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
Time frame: 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
Time frame: Immediately post-intervention (within 1 week after completing the 12-week program).
percentage of eligible participants enrolled
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).
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.
8 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 42903273Watkins J, Goss J, Mehls K, Marshall A, Dlugonski D, Downs DS. Lion Hearts: applying implementation mapping to plan the delivery of a family-based physical activity intervention in community CrossFit affiliates. Front Public Health. 2026 Oct 6;14:1970725. doi: 10.3389/fpubh.2026.1970725. eCollection 2026.
- Individual participant dataSharing planned: No. This is a small-scale pilot feasibility trial, and the dataset is not sufficiently powered or generalizable for meaningful secondary analyses. In addition, the dataset contains sensitive family- and health-related information, which poses a risk of re-identification even with standard de-identification procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lion Hearts Family-Based Physical Activity Program in people with Cardiovascular (CV) Risk, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.