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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07176234
Acronym
LEADS
Enrollment
330
Registered
2025-09-16
Start date
2025-01-25
Completion date
2029-08-10
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Physical Activity

Keywords

stress management, adolescents, resilience, African Americans, family intervention

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.

Interventions

BEHAVIORALTreatment

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).

OTHERHealth Education

Attention Control Comparator

Sponsors

University of South Carolina
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

All measurement staff are blind to conditions.

Intervention model description

Randomized group cohort study design

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
daily minutes of moderate to vigorous physical activitybaseline, post-10 week group session, 6-month follow-up7-day accelerometer estimates using actigraph

Secondary

MeasureTime frameDescription
daily minuties of light physical activitybaseline, post-10 week group session, 6-month follow up7-day accelerometer estimates using actigraph
body mass indexbaseline, post-10 week group session, 6 month follow-upweight (kg)/ height (m)2
Adolescent Self-Regulationbaseline, post 10 week group session, 6 month follow upSelf-Regulation self report scale ranging from 7-35 (higher values are more positive)
Wellbeingbaseline, post 10 week group session, 6 month follow upPsychological wellbeing scale ranging from 24-120 (with higher values being more positive)
Coping with StressBaseline, post 10 week group session, 6 month follow upBrief Cope Scale is a self report scale ranging from 10-40 (with higher scores being more positive)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026