Recruiting

Exercise & Diet

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT06848478

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Nutritional Intervention

Study Details

Brief summary:

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.

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: 12 - 17

Healthy Volunteers: Not accepted

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.

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 standard of care for 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 changes in the composite cardiometabolic health score 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

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • exercise
  • obesity
  • diet
  • cardiometabolic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.