Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Moderate-to-vigorous physical activity - FitBit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
(Control): Waitlist (Delayed Lion Hearts Program)
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
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.
干预措施: Lion Hearts Family-Based Physical Activity Program (Behavioral)
结局指标
主要结局
Moderate-to-vigorous physical activity - FitBit
时间窗: 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
时间窗: Immediately post-intervention (within 1 week after completing the 12-week program).
percentage of eligible participants enrolled
Implementation fidelity of program
时间窗: 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
时间窗: 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
时间窗: Immediately post-intervention (within 1 week after completing the 12-week program).
percentage of eligible participants enrolled
Bioelectrical Impedance Analysis (BIA)
时间窗: 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.
次要结局
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
研究者
Janette Watkins
Assistant professor
Penn State University