Lions Hearts: A Community Approach to Multigenerational Cardiovascular Disease Risk
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lion Hearts Family-Based Physical Activity Program.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular (CV) Risk. Базовые параметры: от 10 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Lion Hearts Family-Based Physical Activity Program
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
Первичные конечные точки
- Moderate-to-vigorous physical activity - FitBit [Срок оценки: 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 [Срок оценки: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Implementation fidelity of program [Срок оценки: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Participant adherence to program [Срок оценки: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Recruitment rate of program [Срок оценки: Immediately post-intervention (within 1 week after completing the 12-week program).]
- Bioelectrical Impedance Analysis (BIA) [Срок оценки: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
Вторичные конечные точки (8)
- submaximal cycle ergometer test - cardiovascular fitness [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (within 1 week prior to intervention start) and immediately post-intervention (within 1 week after completing the 12-week program).]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Penn State University — State College
Идентификаторы
NCT: NCT07147387 · STUDY00027631