NCT06848478

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

Not yet recruiting NA Last updated 3 October 2025

What this trial tests

NA trial testing Exercise Intervention in Obesity in 120 participants. Not yet recruiting.

Timeline

27 October 2025

Primary endpoint
31 March 2029

31 March 2029

Quick facts

Lead sponsor	Arkansas Children's Hospital Research Institute
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	basic science
Enrollment	120
Start date	27 October 2025
Primary completion	31 March 2029
Estimated completion	31 March 2029
Sites	2 locations across United States

Drugs / interventions tested

• Exercise Intervention
• Nutritional Intervention

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Arkansas Children's Hospital Research Institute

Who can join

Adults 13 to 17, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.