Actively Recruiting

Phase Not Applicable
Age: 11Years - 16Years
All Genders
Healthy Volunteers
NCT07176234

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

Led by University of South Carolina · Updated on 2025-10-14

330

Participants Needed

2

Research Sites

236 weeks

Total Duration

On this page

Sponsors

U

University of South Carolina

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 11Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescent BMI greater than or equal to the 70th percentile
  • Self-identified African American or Black adolescents aged 11 to 16 years
  • At least one parent or caregiver participating
  • Not currently in a structured physical activity, weight loss, or stress management program
  • Access to the internet in the home
Not Eligible

You will not qualify if you...

  • Limitations preventing physical activity
  • For caregivers, cardiovascular or orthopedic conditions limiting physical activity
  • Uncontrolled blood pressure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of South Carolina

Columbia, South Carolina, United States, 29208

Actively Recruiting

2

M.H. Newton Family Life Enrichment Center

Sumter, South Carolina, United States, 29150

Actively Recruiting

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Research Team

D

Dawn K. Wilson, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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