Level Up!: Adding exercise and more fruits/vegetables to obesity care for teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized–style interventional study tests whether adding a structured exercise program and a structured fruit-and-vegetable diet to standard obesity care improves cardiometabolic health in adolescents aged 12–17. The 12-week program includes assessments at baseline, week 6, and week 12, using medical history, body composition, blood and urine tests, liver health measurements, resting metabolic rate, and fitness testing. Participants are assigned to one of four groups to isolate the independent and combined effects of exercise and diet. The study is conducted at Arkansas Children’s Hospital and the Arkansas Children’s Nutrition Center in Little Rock, with assessments potentially conducted partially at home.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Elisabet Borsheim, Ph.D — Arkansas Children's Research Institute
• Study coordinator: Hannah Aston, MPH
• Email: AstonHJ@archildrens.org
• Phone: 501-364-3055

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.