Contemporary clinical trials · 2026
Overview of the Linking Exercise for Advancing Daily Stress (LEADS) Management and Resilience Randomized Controlled Trial in African American Families.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Wilson Dawn K, Martin Pamela, Sweeney Allison M, White Taylor, Wood Vashti, Gantt Miriam, Quattlebaum Mary, Grieco Alexandra, Yang Chih-Hsiang, Zarrett Nicole, Gadson Barney, Van Horn M Lee
Аннотация
BACKGROUND: Chronic stressors place African American (AA) adolescents at greater risk for developing chronic diseases. Resilience-based interventions that empower youth to cope with daily chronic stressors have shown improvements across a broad range of outcomes, however, no previous study has evaluated a family-based resilience-stress and coping plus positive parenting intervention on improving physical activity (PA) in AA families.
OBJECTIVE: To describe the design and methodology of the Linking Exercise for Advancing Daily Stress (LEADS) Management and Resilience trial, for evaluating the efficacy of a family-based intervention to address chronic stressors and promote behavioral skills for increasing PA in overweight AA adolescents.
METHODS: The LEADS trial uses a randomized group cohort design and will involve 330 AA adolescents with a BMI percentile ≥70% and a caregiver. The trial tests the efficacy of a 10-week online family-based intervention (vs. health education) and draws from Stress and Coping, Family Systems, and Social Cognitive Theories to integrate components that build coping skills for engaging in PA. The primary outcome is change in daily minutes of moderate-to-vigorous PA (MVPA) at post-intervention and 6-month follow-up among adolescents. Secondary outcomes include changes at post-intervention and 6-month follow-up in MVPA in caregivers, as well as changes in light PA (LPA), dietary intake, family mealtime, body mass index, waist circumference, and blood pressure in adolescents and caregivers.
CONCLUSION: This trial will evaluate an online family-based resilience-stress and coping plus positive parenting intervention and is expected to inform best practices for promoting health among AA families.
OBJECTIVE: To describe the design and methodology of the Linking Exercise for Advancing Daily Stress (LEADS) Management and Resilience trial, for evaluating the efficacy of a family-based intervention to address chronic stressors and promote behavioral skills for increasing PA in overweight AA adolescents.
METHODS: The LEADS trial uses a randomized group cohort design and will involve 330 AA adolescents with a BMI percentile ≥70% and a caregiver. The trial tests the efficacy of a 10-week online family-based intervention (vs. health education) and draws from Stress and Coping, Family Systems, and Social Cognitive Theories to integrate components that build coping skills for engaging in PA. The primary outcome is change in daily minutes of moderate-to-vigorous PA (MVPA) at post-intervention and 6-month follow-up among adolescents. Secondary outcomes include changes at post-intervention and 6-month follow-up in MVPA in caregivers, as well as changes in light PA (LPA), dietary intake, family mealtime, body mass index, waist circumference, and blood pressure in adolescents and caregivers.
CONCLUSION: This trial will evaluate an online family-based resilience-stress and coping plus positive parenting intervention and is expected to inform best practices for promoting health among AA families.