Physical ActivityLEADSNCT07176234
The LEADS Trial (Linking Exericise for Advancing Daily Stress Management)
A study testing Treatment and Health Education in people with Physical Activity and Childhood Obesity, run by University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Childhood Obesity
- What is being tested?
- Treatment and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2025to 10 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of South Carolina
Columbia, South Carolina, 29208
M.H. Newton Family Life Enrichment Center
Sumter, South Carolina, 29150
About this study
Official title: Linking Exericise for Advancing Daily Stress (LEADS) Management and Resilience in African American Families
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
- Physical Activity, Childhood Obesity
- Being tested
- Treatment, Health Education
- Keywords
- stress management, adolescents, resilience, African Americans, family intervention
- Medical subject headings
- Motor Activity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentBehavioural
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 EducationOther
Attention Control Comparator
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Health Education | Active comparator | Includes a series of health education sessions, including hypertension, diabetes, cancer, sleep, social media advocacy, metabolism, financial literacy. Receives: Other: Health Education |
| Intervention Arm | Experimental | Behavioral Intervention for reducing stress and increasing resilience for improve physical activity, healthy diet, and wellbeing Receives: Behavioral: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily minutes of moderate to vigorous physical activity
7-day accelerometer estimates using actigraph
Measured: baseline, post-10 week group session, 6-month follow-up
Secondary outcomes (5)
daily minuties of light physical activity
7-day accelerometer estimates using actigraph
Measured: baseline, post-10 week group session, 6-month follow up
body mass index
weight (kg)/ height (m)2
Measured: baseline, post-10 week group session, 6 month follow-up
Adolescent Self-Regulation
Self-Regulation self report scale ranging from 7-35 (higher values are more positive)
Measured: baseline, post 10 week group session, 6 month follow up
Wellbeing
Psychological wellbeing scale ranging from 24-120 (with higher values being more positive)
Measured: baseline, post 10 week group session, 6 month follow up
Coping with Stress
Brief Cope Scale is a self report scale ranging from 10-40 (with higher scores being more positive)
Measured: Baseline, post 10 week group session, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start25 Jan 2025
- Primary completion10 Aug 2029 (estimated)
- Study completion10 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized group cohort study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Dawn Wilson, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176234
- Sponsor's protocol ID
- Pro00135549
- Other IDs
- R01MD019714
- Acronym
- LEADS
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include data from 330 Black/African American families (parent/adolescent dyads). We will make available behavioral, psychosocial, physiological, and physical activity data after the data provided by this grant has been published in peer-reviewed journals, consistent with the Final NIH Statement on Sharing Research Data. The final dataset will be stripped of identifiers prior to release for sharing. Data will be made available in a format consistent with community standards in a spreadsheet-based data exchange format. Once available, data can be requested by email to the Principal Scientific Investigator. Regarding our management of intellectual property, we will adhere to the NIH Policy on Sharing of Unique Research Resources as specified in Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Exericise for Advancing Daily Stress (LEADS) Management and Resilience in African American Families
- ClinicalTrials.gov ID
- NCT07176234
- Acronym / sponsor ID
- LEADS / Pro00135549
- Conditions
- Physical Activity, Childhood Obesity
- Keywords
- stress management, adolescents, resilience, African Americans, family intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 10 Aug 2029 (estimated)
- Study completion
- 10 Aug 2029 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized group cohort study design
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Health Education | Active comparator | Other: Health EducationIncludes a series of health education sessions, including hypertension, diabetes, cancer, sleep, social media advocacy, metabolism, financial literacy. |
| Intervention Arm | Experimental | Behavioral: TreatmentBehavioral Intervention for reducing stress and increasing resilience for improve physical activity, healthy diet, and wellbeing |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentThe 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). | Behavioural | Intervention Arm |
| Health EducationAttention Control Comparator | Other | Comprehensive Health Education |
Primary outcome
daily minutes of moderate to vigorous physical activity
Time frame: baseline, post-10 week group session, 6-month follow-up
7-day accelerometer estimates using actigraph
5 secondary outcomes
daily minuties of light physical activity
Time frame: baseline, post-10 week group session, 6-month follow up
body mass index
Time frame: baseline, post-10 week group session, 6 month follow-up
Adolescent Self-Regulation
Time frame: baseline, post 10 week group session, 6 month follow up
Wellbeing
Time frame: baseline, post 10 week group session, 6 month follow up
Coping with Stress
Time frame: Baseline, post 10 week group session, 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. The proposed research will include data from 330 Black/African American families (parent/adolescent dyads). We will make available behavioral, psychosocial, physiological, and physical activity data after the data provided by this grant has been published in peer-reviewed journals, consistent with the Final NIH Statement on Sharing Research Data. The final dataset will be stripped of identifiers prior to release for sharing. Data will be made available in a format consistent with community standards in a spreadsheet-based data exchange format. Once available, data can be requested by email to the Principal Scientific Investigator. Regarding our management of intellectual property, we will adhere to the NIH Policy on Sharing of Unique Research Resources as specified in Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment and Health Education in people with Physical Activity and Childhood Obesity, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily minutes of moderate to vigorous physical activity (time frame: baseline, post-10 week group session, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.