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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Arkansas Children's Hospital Research Institute

Record History

  1. Notable Primary endpoint(s) modified Eligibility criteria shortened, about 25 words · Secondary endpoints revised (4) · Study description expanded, about 93 words Show 3 more changesShow less
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 93 words
  2. Notable Recruitment opened Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute · Start date changed from estimate of Jun 1, 2026 to Jun 4, 2026 · Eligibility criteria expanded, about 24 words · 3 more Show 6 more changesShow less
    • Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute
    • Start date changed from estimate of Jun 1, 2026 to Jun 4, 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 10 words
    • Site details revised at 2 of 2 sites
  3. Notable Start date: Oct 27, 2025 to Jun 1, 2026v3
  4. Notable Start date: Apr 1, 2025 to Oct 27, 2025 Primary endpoints: 16 to 1 · Secondary endpoints expanded, about 39 words · Study description expanded, about 151 words · 1 morev2 Show 4 more changesShow less
    • Primary endpoints: 16 to 1
    • Secondary endpoints expanded, about 39 words
    • Study description expanded, about 151 words
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06848478
Lead Sponsor Arkansas Children's Hospital Research Institute
Conditions Obesity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov