跳至主要内容
临床试验/NCT07176234
NCT07176234Enrolling By Invitation不适用

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

University of South Carolina2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2025年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
330
试验地点
2
主要终点
daily minutes of moderate to vigorous physical activity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All measurement staff are blind to conditions.

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Comprehensive Health Education

Active Comparator

Includes a series of health education sessions, including hypertension, diabetes, cancer, sleep, social media advocacy, metabolism, financial literacy.

干预措施: Health Education (Other)

Intervention Arm

Experimental

Behavioral Intervention for reducing stress and increasing resilience for improve physical activity, healthy diet, and wellbeing

干预措施: Treatment (Behavioral)

结局指标

主要结局

daily minutes of moderate to vigorous physical activity

时间窗: baseline, post-10 week group session, 6-month follow-up

7-day accelerometer estimates using actigraph

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Wilson

Professor of Psychology

University of South Carolina

研究点 (2)

Loading locations...

相似试验