NCT07176234: LEADS

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

Recruiting now NA Last updated 14 October 2025

What this trial tests

NA trial testing Treatment in Obesity, Childhood in 330 participants. Currently enrolling.

Timeline

25 January 2025

Primary endpoint
10 August 2029

10 August 2029

Quick facts

Lead sponsor	University of South Carolina
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	330
Start date	25 January 2025
Primary completion	10 August 2029
Estimated completion	10 August 2029
Sites	2 locations across United States

Drugs / interventions tested

• Treatment — full drug profile →
• Health Education

Conditions studied

• Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

University of South Carolina

Who can join

Adults 11 to 16, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.