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

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT07176234
Status
Enrolling By Invitation

Conditions

  • Childhood Obesity
  • Physical Activity

Eligibility Criteria

Sex
ALL
Age
11 Years - 16 Years
Healthy Volunteers
Accepted

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).
  • Health Education — OTHER
    Attention Control Comparator

Study Details

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.

Key Dates

Start date
Jan 25, 2025
Status verified
Jun 2026
Primary completion
Aug 10, 2029
Completion
Aug 10, 2029

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Comprehensive Health Education
    Includes a series of health education sessions, including hypertension, diabetes, cancer, sleep, social media advocacy, metabolism, financial literacy.
  • Experimental: Intervention Arm
    Behavioral Intervention for reducing stress and increasing resilience for improve physical activity, healthy diet, and wellbeing

Primary Outcome Measure

daily minutes of moderate to vigorous physical activity [ Time Frame: baseline, post-10 week group session, 6-month follow-up ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208-
M.H. Newton Family Life Enrichment CenterSumterSouth Carolina29150-

Find similar trials in Columbia, SC

By research site
University of South Carolina· Columbia, SCM.H. Newton Family Life Enrichment Center· Sumter, SC

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