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Enrolling by Invitation

NCT Number: NCT07176234

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

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.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina, Columbia, South Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Treatment

Behavioral

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).

Health education

Other

Attention Control Comparator

Primary outcomes

  1. daily minutes of moderate to vigorous physical activity

    Time frame: baseline, post-10 week group session, 6-month follow-up

    7-day accelerometer estimates using actigraph

Secondary outcomes

  1. daily minuties of light physical activity

    Time frame: baseline, post-10 week group session, 6-month follow up

    7-day accelerometer estimates using actigraph

  2. body mass index

    Time frame: baseline, post-10 week group session, 6 month follow-up

    weight (kg)/ height (m)2

  3. Adolescent Self-Regulation

    Time frame: baseline, post 10 week group session, 6 month follow up

    Self-Regulation self report scale ranging from 7-35 (higher values are more positive)

  4. Wellbeing

    Time frame: baseline, post 10 week group session, 6 month follow up

    Psychological wellbeing scale ranging from 24-120 (with higher values being more positive)

  5. Coping with Stress

    Time frame: Baseline, post 10 week group session, 6 month follow up

    Brief Cope Scale is a self report scale ranging from 10-40 (with higher scores being more positive)

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: LEADS

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 16, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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