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

NCT ID: NCT07176234

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2029-08-10

Brief Summary

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

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Comprehensive Health Education

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

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: OTHER

Attention Control Comparator

Intervention Arm

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

Group Type: EXPERIMENTAL

Treatment

Intervention Type: 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).

Interventions

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 (self-affirmation), and positive parenting practices (parent support, nurturance, family routines).

Intervention Type: BEHAVIORAL

Health Education

Attention Control Comparator

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Dawn Wilson

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Carolina

Columbia, South Carolina, United States

Site Status: RECRUITING

M.H. Newton Family Life Enrichment Center

Sumter, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dawn K. Wilson, Ph.D.

Role: CONTACT

wilsondk@mailbox.sc.edu

803-777-4137

Facility Contacts

Dawn K Wilson, PhD

Role: primary

8039787500

Barney Gadson

Role: primary

barneygadson@yahoo.com

803 934 0022

Other Identifiers

R01MD019714

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00135549

Identifier Type: -

Identifier Source: org_study_id