RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Arkansas Children's Hospital Research Institute • ClinicalTrials.gov ID: NCT06848478

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

The goal of this clinical trial is to determine whether adding structured exercise training and a structured fruit and vegetable dietary program to standard multidisciplinary obesity care improves cardiometabolic health in adolescents with obesity enrolled in a weight management program. The main questions it aims to answer are: * Does adding structured exercise training to standard multidisciplinary obesity care improve cardiometabolic health? * Does adding a structured fruit and vegetable dietary program to standard multidisciplinary obesity care improve cardiometabolic health? * Does combining structured exercise training and the fruit and vegetable dietary program with standard multidisciplinary obesity care improve cardiometabolic health? Researchers will compare four groups to evaluate the independent and combined effects of structured exercise training and a structured fruit and vegetable dietary program: * Standard Care Group: Receives standard multidisciplinary obesity care. * Exercise Group: Receives standard care plus a 12-week supervised, structured multicomponent exercise program, weekly exercise counseling, and continuous physical activity monitoring using a tracker. * Dietary Group: Receives standard care plus a 12-week fruit and vegetable enrichment program involving daily smoothie consumption designed to provide one cup of fruit and one cup of vegetables per day, using frozen smoothie ingredient packages delivered to participants' homes, and weekly dietary coaching. * Combined Exercise and Dietary Group: Receives standard care plus both the structured exercise and fruit and vegetable dietary programs. During the 12-week study, participants will complete assessments at baseline, week 6, and week 12. Some procedures may be completed at home or split across more than one day. Assessments may include: * Providing blood, urine, and stool samples. * Completing questionnaires about health, sleep, diet, physical activity, mood, and other health behaviors. * Undergoing body-composition scans to measure fat, lean, and bone mass. * Completing blood-vessel function, liver-fat, and skin-carotenoid assessments. * Completing continuous glucose monitoring. * Assessing resting energy expenditure. * Completing fitness and muscle-strength tests. * Completing a standardized meal-based metabolic assessment. * Completing 3-day dietary records. * Wearing activity and sleep monitors to assess physical activity and sleep patterns.

Interventions

Exercise Intervention (Behavioral)
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.
Nutritional Intervention (Behavioral)
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.

Eligibility criteria

Inclusion criteria * Male or female aged 12 to 17 years. * Enrolled in the weight management program at the COACH clinic. * Class I obesity (≥95th percentile to \<120% of the 95th percentile), class II obesity (≥120% to \<140% of the 95th percentile, or BMI ≥35 to \<40 kg/m²), and class III obesity (≥140% of the 95th percentile, or BMI ≥40 kg/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 from COACH clinic to perform exercise. Exclusion criteria * Type 1 and Type 2 diabetes mellitus. * Asthma that requires the use of rescue inhalers (e.g., albuterol) \>2 days per week. * Exercise-induced asthma. * Epilepsy. * Cancer. * Chronic kidney disease. * 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 (urine test). * Dislike of all the fruit and vegetable smoothie options pre-defined by the study team at the initial visit. * Parent/child refusal to have blood drawn. * Refusal to authorize study investigators to access data from the COACH clinic.

Conditions

Obesity

Locations

Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
Arkansas Children's Nutrition Center — Little Rock, Arkansas, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment