NCT06848478 · Arkansas Children's Hospital Research Institute
Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
What this study is about
The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity.
View original scientific description
The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity. The main questions it aims to answer are: * Does exercise improve cardiometabolic health in adolescents with obesity? * Does enriching the diet with fruits and vegetables improve cardiometabolic health in adolescents with obesity? * Do exercise and a fruit and vegetable diet together provide greater health benefits than either one alone in adolescents with obesity? Researchers will compare four groups to see how exercise and diet impact health: * Standard Care Group: Receives the usual care for obesity. * Exercise Group: Receives weekly exercise coaching and participates in a 12-week exercise program. * Diet Group: Receives weekly dietary coaching and eats a diet enriched with fruits and vegetables for 12 weeks. * Combined Exercise and Diet Group: Receives both exercise and dietary programs, namely weekly exercise and dietary coaching, participation in a 12-week exercise program, and daily consumption of fruits and vegetables for 12 weeks. During the 12-week study, participants will attend three study visits to: * Provide blood, stool, and urine samples. * Answer questions about health, sleep, diet, and physical activity. * Undergo body scans to measure fat, lean, and bone mass. * Complete blood vessel function and liver fat content assessments. * Assess resting exergy expenditure. * Complete fitness tests. * Wear a fitness tracker to monitor physical activity and sleep patterns.
Interventions
BEHAVIORAL
Exercise Intervention
In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week.
BEHAVIORAL
Nutritional Intervention
In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables.
Primary outcome measures
Group differences in changes in the composite cardiometabolic health score over time
Time frame: Baseline, 6 weeks, and 12 weeks.
The primary outcome is a composite cardiometabolic health score. It is calculated as the mean of standardized z-scores for fasting triglycerides (mg/dL), total cholesterol/HDL-cholesterol ratio, HOMA2-IR, systolic blood pressure (mmHg), fat-mass index \[whole-body fat mass (kg)/height² (m²)\], and inverse peak oxygen uptake (mL O₂/kg/min).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female aged 13 to 17 years.
- Newly enrolled in a weight management program.
- Excessive weight: Class I obesity I (≥95% percentile to \< 120% of the 95th percentile), class II Obesity (≥120 to \<140% of the 95th percentile, or BMI ≥35 to \< 40 g/m2).
- Less than 60 min/day of moderate to vigorous physical activity.
- Fruit intake ≤ 1.5 cup equivalent per day.
- Vegetable intake ≤ 1.5 cup equivalent per day.
- Medical release.
Exclusion criteria
- Type 2 diabetes mellitus.
- Asthma that requires daily use of inhalers to keep symptoms under control.
- Asthma that requires the use of rescue inhalers (e.g., albuterol) \>2 days per week
- Exercise-induced asthma.
- Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
- Chronic kidney disease.
- Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).
- Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis).
- Bleeding disorders (e.g., hemophilia).
- Chronic infections (e.g., HIV, hepatitis B, hepatitis C).
- Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
- Dislike of \> 1 study product assessed at the initial visit.
- Parent/child refusal to have blood drawn.
- Refusal to authorize study investigators to access data from the clinical records.
Where
- Little Rock, Arkansas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations