The LEADS Trial (Linking Exericise for Advancing Daily Stress Management)

Официальное название

Linking Exericise for Advancing Daily Stress (LEADS) Management and Resilience in African American Families

Обзор

Chronic stressors have wide-reaching harmful effects on the physical, social, and psychological well-being of many African American (AA) families. These stressors place some AA adolescents, who already experience low rates of physical activity (PA) and high rates of obesity, at even greater risk for developing chronic diseases. Previous family-based interventions have targeted PA, diet, and sedentary behaviors to prevent and manage overweight and obesity, but few have been successful for AA adolescents. The investigators propose that this may be because chronic stressors are a major challenge to engagement in health promotion efforts, which has been significantly overlooked in previous interventions for AA families. Resilience-based interventions that empower youth to cope with daily stressors have shown improvements across a broad range of outcomes including mental health, academic achievement, and risk-taking behaviors. However, no previous study has evaluated a family-based stress and coping plus positive parenting intervention on improving engagement in PA in AA families. The Linking Exercise for Advancing Daily Stress (LEADS) Management intervention integrates a family-based intervention to address chronic stressors to promote behavioral skills for increasing PA in overweight AA adolescents and their parents. Based on Lazarus and Folkman's Stress and Coping Model, Family Systems, and Social Cognitive Theories, the proposed intervention integrates components that build coping skills (mindfulness, deep breathing, active coping, cognitive reframing), self-esteem (self-affirmation), and positive parenting practices (parent support, nurturance, family routines). The investigators propose that these protective factors as integrated into the LEADS intervention will buffer the negative effects of chronic stressors, which will lead to greater improvements in PA. The investigators pilot research indicates that the LEADS family-based intervention was feasible and acceptable and led to increased moderate-to-vigorous PA (MVPA) for adolescents. Thus, the primary aim of this study is 1) to evaluate the efficacy of the LEADS intervention on increasing MVPA from baseline to post-intervention, and maintenance at a 6-month follow-up in overweight AA adolescents. Secondary aims will examine 2) the effect of the LEADS intervention on light PA, dietary intake, family mealtime, body mass index, waist circumference, and blood pressure outcomes, 3) the effects of the intervention on parent outcomes, as well as examining 4) mediators of the intervention effect on changes in PA.

Вмешательства

• Поведенческое Treatment
  The Linking Exercise for Advancing Daily Stress (LEADS) Management intervention integrates a family-based intervention to address chronic stressors to promote behavioral skills for increasing PA in overweight AA adolescents and their parents. Based on Lazarus and Folkman's Stress and Coping Model, Family Systems, and Social Cognitive Theories, the proposed intervention integrates components that build coping skills (mindfulness, deep breathing, active coping, cognitive reframing), self-esteem (s
• Другое Health Education
  Attention Control Comparator

Первичные конечные точки

• daily minutes of moderate to vigorous physical activity [Срок оценки: baseline, post-10 week group session, 6-month follow-up]

Вторичные конечные точки (5)

• daily minuties of light physical activity [Срок оценки: baseline, post-10 week group session, 6-month follow up]
• body mass index [Срок оценки: baseline, post-10 week group session, 6 month follow-up]
• Adolescent Self-Regulation [Срок оценки: baseline, post 10 week group session, 6 month follow up]
• Wellbeing [Срок оценки: baseline, post 10 week group session, 6 month follow up]
• Coping with Stress [Срок оценки: Baseline, post 10 week group session, 6 month follow up]

Критерии участия

Критерии включения

• adolescent BMI greater than or equal 70th percentile;
• self-identified African American or Black adolescents 11-16 years;
• at least one parent/caregiver participating;
• not currently in a structured physical activity, weight loss program or stress management program
• access to the internet in his/her home.

Критерии исключения

• having limitations that would prevent physical activity, and for caregivers,
• criteria will include having a cardiovascular or orthopedic condition that would limit physical activity
• uncontrolled blood pressure.

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of South Carolina — Columbia
• M.H. Newton Family Life Enrichment Center — Sumter

Идентификаторы

NCT: NCT07176234 · Pro00135549 · R01MD019714

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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