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

April 22, 2026 updated by: Arkansas Children's Hospital Research Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Level Up! study is a 12-week randomized controlled trial designed to investigate the independent and combined effects of exercise training and dietary enrichment on cardiometabolic health in adolescents with obesity. The study will enroll adolescents participating in an obesity treatment program. Participants will be randomly assigned to one of four groups: standard of care, exercise, dietary, or combined exercise and dietary intervention.

Each participant will attend three assessment visits at baseline, week 6, and week 12 at the Arkansas Children's Nutrition Center (ACNC). The following key measurements will be conducted:

  • Body Composition: Dual-Energy X-ray Absorptiometry (DXA)
  • Metabolic Profile: Fasting blood markers, including glucose, lipid profile, and insulin resistance
  • Vascular Function: Brachial artery flow-mediated dilation (ultrasound)
  • Liver Fat Content: Elastography
  • Continuous Glucose Monitoring: Interstitial sensor-based glucose measurement
  • Resting Metabolic Rate: Indirect calorimetry
  • Aerobic Capacity: Cardiopulmonary exercise test (spirometry)
  • Muscle Strength: Dynamometry
  • Physical Activity & Sleep: Accelerometry
  • Dietary Intake: 3-day food records

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Elisabet Borsheim, Ph.D.
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants receive the standard of care for treating Class I and II obesity.
Experimental: 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: 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.
Experimental: 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.
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.
Experimental: Exercise and Nutritional Intervention
In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group differences in composite score of cardiometabolic health changes over time.
Time Frame: Baseline, 6 weeks, and 12 weeks.
The primary outcome is a composite score of cardiometabolic health status. The score is calculated as the mean of specific z-scores for the following markers: 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). The composite score is computed as the mean of the standardized z-scores for each marker, providing an overall measure of cardiometabolic health status.
Baseline, 6 weeks, and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Group differences in low-density lipoprotein (LDL) cholesterol (mg/dL) changes over time.
Time Frame: Baseline, 6 weeks, and 12 weeks.
Baseline, 6 weeks, and 12 weeks.
Group differences in fow-mediated dilation (%) changes over time.
Time Frame: Baseline, 6 weeks, and 12 weeks.
Baseline, 6 weeks, and 12 weeks.
Group differences in liver steatosis (dB/m) changes over time.
Time Frame: Baseline and 12 weeks.
Baseline and 12 weeks.
Group differences in appendicular lean mass index changes over time.
Time Frame: Baseline, 6 weeks, and 12 weeks.
Baseline, 6 weeks, and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Elisabet Borsheim, Ph.D, Arkansas Children's Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 287133
  • USDA/ARS 6026-10700-001-000D (Other Grant/Funding Number: United States Department of Agriculture (USDA) - Agricultural Research Service (ARS))
  • U1111-1339-4285 (Registry Identifier: World Health Organization (WHO) Universal Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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