Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents with Obesity)

Not Applicable

Not yet recruiting

• Conditions: Obesity

• Registration Number: NCT06848478
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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 (FV) improve cardiometabolic health in adolescents with obesity?

* Do exercise and FV diet together provide greater health benefits than either 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-04-01
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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).
• Epilepsy.
• Cancer.
• 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.
• Pregnancy.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Group differences in cardiorespiratory fitness (O₂ mL/kg/min) changes over time.	Baseline, 6 weeks, and 12 weeks.	Cardiorespiratory fitness measured using indirect calorimetry through cardiopulmonary exercise testing to determine VO₂ peak.
Group differences in percentage of body fat (%) changes over time.	Baseline, 6 weeks, and 12 weeks.	Percentage of body fat measured using dual-energy X-ray absorptiometry (DXA).
Group differences in flow-mediated dilation (%) changes over time.	Baseline, 6 weeks, and 12 weeks.	Flow-mediated dilation measured using ultrasound.
Group differences in systolic blood pressure (mmHg) changes over time.	Baseline, 6 weeks, and 12 weeks.	Systolic blood pressure measured using an automated blood pressure monitor.
Group differences in insulin sensitivity changes over time.	Baseline, 6 weeks, and 12 weeks.	Insulin sensitivity measured using the homeostatic model assessment of insulin resistance (HOMA-IR).
Group differences in liver steatosis (dB/m) changes over time.	Baseline, and 12 weeks.	Liver steatosis measured using elastography.
Group differences in fasting glucose (mg/dL) changes over time.	Baseline, 6 weeks, and 12 weeks.	Fasting glucose measured using an enzymatic colorimetric method.
Group differences in fasting insulin (µU/mL) changes over time.	Baseline, 6 weeks, and 12 weeks.	Fasting insulin measured using an immunoassay method.
Group differences in diastolic blood pressure (mmHg) changes over time.	Baseline, 6 weeks, and 12 weeks.	Diastolic blood pressure measured using an automated blood pressure monitor.
Group differences in low-density lipoprotein (LDL) cholesterol (mg/dL) changes over time.	Baseline, 6 weeks, and 12 weeks.	Low-density lipoprotein (LDL) cholesterol measured using a direct enzymatic method.
Group differences in high-density lipoprotein (HDL) cholesterol (mg/dL) changes over time.	Baseline, 6 weeks, and 12 weeks.	High-density lipoprotein (HDL) cholesterol measured using a direct enzymatic method.
Group differences in total cholesterol (mg/dL) changes over time.	Baseline, 6 weeks, and 12 weeks.	Total cholesterol measured using an enzymatic assay.
Group differences in triglycerides (mg/dL) changes over time.	Baseline, 6 weeks, and 12 weeks.	Triglycerides measured using an enzymatic assay.
Group differences in resting energy expenditure (kcal/day) changes over time.	Baseline, and 12 weeks.	Resting energy expenditure measured using indirect calorimetry.
Group differences in time spent in moderate-to-vigorous physical activity (minutes/day) changes over time.	Baseline, 6 weeks, and 12 weeks.	Time spent in moderate-to-vigorous physical activity measured using an accelerometer.
Group differences in dietary intake quality (Healthy Eating Index) changes over time.	Baseline, 6 weeks, and 12 weeks.	Dietary intake quality measured using the Healthy Eating Index (HEI) based on 3-day dietary records.

Trial Locations

Locations (2)

Arkansas Children's Hospital Research Institute; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States