Exercise for Childhood Obesity

(LEADS Trial)

Recruiting at 1 trial location

Overseen By Dawn K. Wilson, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Physical limitations, Cardiovascular, Orthopedic, Uncontrolled blood pressure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help African American adolescents manage stress and increase physical activity to address obesity. The treatment, called the LEADS Intervention, includes a family-based program that teaches coping skills such as mindfulness and deep breathing, along with positive parenting practices. The trial compares the effectiveness of this program to a comprehensive health education series. Adolescents who identify as African American, have a BMI at or above the 70th percentile, and are not currently enrolled in a structured physical activity or stress management program are suitable candidates. Participants need internet access at home for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research aimed at improving adolescent health and well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LEADS intervention is safe for increasing physical activity in overweight African American adolescents?

Research has shown that family-based programs like the LEADS program can effectively manage childhood obesity. Studies have found that these programs lead to weight loss and improved physical activity without serious side effects. Specifically, programs focused on weight management for children and teens have safely reduced body mass index (BMI).

The LEADS program aims to help African American teens and their families manage stress and increase activity levels. Early research found the program practical and well-received, with participants increasing their physical activity. This indicates that the program is both safe and well-accepted by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LEADS Intervention for childhood obesity because it goes beyond just promoting physical activity and healthy eating. Unlike typical treatments that often focus solely on diet and exercise, this intervention includes a behavioral component aimed at reducing stress and building resilience. This unique approach not only targets the physical aspects of obesity but also addresses mental well-being, which can lead to more sustainable lifestyle changes. Additionally, the comprehensive health education offered in the active comparator arm covers a wide range of topics like financial literacy and social media advocacy, providing a well-rounded educational experience that could empower participants to make healthier choices in various aspects of their lives.

What evidence suggests that the LEADS intervention is effective for increasing physical activity in overweight African American adolescents?

This trial will compare the LEADS Intervention, which focuses on managing stress and building resilience, with a Comprehensive Health Education program. Studies have shown that family-based programs like the LEADS Intervention can significantly increase teenagers' physical activity levels. Research indicates that when families collaborate to manage stress and support each other, children are more likely to engage in moderate-to-vigorous physical activities. Early results suggest that these programs can also improve body mass index (BMI), waist size, and overall health. Previous participants demonstrated that these methods help reduce the risk of long-term health issues associated with obesity. The LEADS program specifically includes skills for coping, boosting self-esteem, and positive parenting practices, which have been shown to increase involvement in physical activity. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The LEADS Trial is for African American adolescents and their parents who are dealing with obesity. Participants should be experiencing chronic stress, have low physical activity levels, and be at risk of chronic diseases. The trial aims to help them cope with daily stressors and improve their engagement in health-promoting activities.

Inclusion Criteria

Access to the internet in his/her home

At least one parent/caregiver participating

Not currently in a structured physical activity, weight loss, or stress management program

Exclusion Criteria

I have physical limitations that stop me from being active.

I have a heart or bone condition limiting my activity or uncontrolled blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the LEADS intervention focusing on stress management and physical activity over a 10-week period

10 weeks

Weekly group sessions

Follow-up

Participants are monitored for maintenance of physical activity and other health outcomes

6 months

Follow-up assessments at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• LEADS Intervention

Trial Overview This study tests a family-based intervention called the LEADS program, which includes coping skills training (like mindfulness and deep breathing), self-esteem building exercises, and positive parenting practices to increase physical activity among overweight African American adolescents.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Comprehensive Health Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7436851/

Childhood Obesity Intervention Studies A narrative review and guide for investigators, authors, editors, reviewers, journalists, and readers to guard against exaggerated effectiveness claims.

2. publications.aap.org publications.aap.org/pediatrics/article/153/2/e2023064453/196483/Improving-the-Effectiveness-and-Equity-of-Child

Improving the Effectiveness and Equity of Child Obesity ... The multicomponent intervention resulted in a greater increase in BMI percent 95 (BMI percent 95 is the percentage of the 95th percentile and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221133552200393X

Outcomes of a 24-month childhood obesity prevention ... The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

4. bmjpublichealth.bmj.com bmjpublichealth.bmj.com/content/3/1/e001707

Factors associated with the effectiveness of interventions to ... Interventions were effective on average (MD in zBMI −0.037, 95% credible interval −0.053 to −0.022). The greatest effects were associated with ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2829443

Effect of Pediatric Obesity Treatment on Long-Term Health Findings This cohort study demonstrated that good response to pediatric obesity treatment was associated with reduced long-term morbidity, such ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4504253/

Family-Based Interventions Targeting Childhood Obesity To date, there is preliminary evidence suggesting that family-based interventions targeting childhood obesity are successful in producing weight loss in the ...

7. publications.aap.org publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and

Clinical Practice Guideline for the Evaluation and ... Childhood obesity results from a multifactorial set of socioecological, environmental, and genetic influences that act on children and families.

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2820245

Interventions for Weight Management in Children and ... In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000506

Evaluating the Long-Term Effectiveness of a Structured ... This study evaluated the long-term effectiveness of a structured pediatric telehealth intervention compared to historical in-person treatment.

10. nature.com nature.com/articles/s41366-022-01198-w

Core outcome set for early intervention trials to prevent ... The core outcome set will standardise guidance on the measurement and reporting of outcomes from early childhood obesity prevention ...