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

NCT06848478 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-24

No results posted yet for this study

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 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.

Conditions

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.

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Elisabet Borsheim, Ph.D · Arkansas Children's Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848478 on ClinicalTrials.gov