Recruiting

Exercise & Diet

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT06848478

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Nutritional Intervention

Study Details

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 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

Obesity

Study ID

NCT06848478

Start date

Jun 4, 2026

Status verified date

Sep, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Group differences in composite score of cardiometabolic health changes over time. [ Time Frame: Baseline, 6 weeks, and 12 weeks. ]

Central Contacts and Locations

Central contacts

Hannah Aston, MPH

501-364-3055AstonHJ@archildrens.org

Florêncio Sousa, Ph.D.

JFDinizdesousa@uams.edu

Locations

Arkansas Children's Hospital Research Institute

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Elisabet Borsheim, Ph.D.

501-364-3053EBorsheim@uams.edu

Principal Investigator:

Elisabet Borsheim, Ph.D.

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72202

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • exercise
  • obesity
  • diet
  • cardiometabolic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2026-09-15.