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

Enrolling by invitation · Not applicable

Conditions studied: Physical Activity, Childhood Obesity

In brief

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.

Key facts

Study ID

NCT07176234

Run by

University of South Carolina

People needed

330

Starts

2025-01-25

Expected to finish

2029-08-10

Last updated by the study team

2026-06-09

Who can join

Age: 11 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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