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

RecruitingNAAges 12 Years - 17 YearsAllArkansas Children's Hospital Research Institute
NCT06848478 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Exercise Intervention
  • Nutritional Intervention
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Where

2 sites
Arkansas Children's Hospital Research Institute
Little Rock, United States
Arkansas Children's Nutrition Center
Little Rock, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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