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

NCT07176234 | Recruiting DMC

• 2 other identifiers: Pro00135549R01MD019714
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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

Keywords

physical activity, stress management, adolescent, intervention, African American

Outcome Measures

Primary Outcomes (1)

• daily minutes of moderate to vigorous physical activity

  7-day accelerometer estimates using actigraph

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Comprehensive Health Education

ACTIVE COMPARATOR

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

Other: Health Education

Intervention Arm

EXPERIMENTAL

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

Behavioral: Treatment

Interventions

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).

Intervention Arm

Health Education OTHER

Attention Control Comparator

Comprehensive Health Education

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

M.H. Newton Family Life Enrichment Center

Sumter, South Carolina, 29150, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Dawn K. Wilson, Ph.D.

CONTACT

803-777-4137; wilsondk@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All measurement staff are blind to conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Randomized group cohort study design

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: January 25, 2025
• Primary Completion (Estimated): August 10, 2029
• Study Completion (Estimated): August 10, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the trial has been completed and published we will make the data available.
• Access Criteria: Data Preservation, Access, and Associated Timeline The study data will be submitted to a repository that is participating in the NIH Generalist Repository Initiative. We will submit metadata associated with the datasets to Vivli. Scientific data will be shared as soon as possible. Access, Distribution and Reuse The study datasets will be collected following informed consent as set by the NIH and IRB at the University of South Carolina. To protect research participants' privacy and confidentiality, data submitted to the repository will not include personal identifiable information such as names or addresses.

Locations

US (2)