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NCT06848478 · ClinicalTrials.gov registry record · NA
Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
A NA study, sponsored by Arkansas Children's Hospital Research Institute.
- Not yet
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT06848478: Clinical Trial NA study, sponsored by Arkansas Children's Hospital Research Institute.
NCT06848478 is a NA study that has not yet begun recruiting, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06848478, a NA study, has not yet begun recruiting, sponsored by Arkansas Children's Hospital Research Institute.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome is a composite score of cardiometabolic health status. The score is calculated as the mean of specific z-scores for the following markers: fasting triglycerides (mg/dL), total cholesterol/HDL-cholesterol ratio, HOMA2-IR, systolic blood pressure (mmHg), fat-mass-index \[whole-body fat mass (kg)/height² (m²)\], and inverse peak oxygen uptake (mL O₂/kg/min). The composite score is computed as the mean of the standardized z-scores for each marker, providing an overall measure of
Interventions
- BEHAVIORAL Exercise Intervention
- BEHAVIORAL Nutritional Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2029-03-31 |
| Phase | NA |
What is known before NCT06848478 opens enrollment
NCT06848478 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Exercise Intervention is the first listed.
NCT06848478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06848478 about?
NCT06848478 is a clinical study titled "Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)". 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...
What is the current status of trial NCT06848478?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2026-06-01. Estimated completion is 2029-03-31.
What interventions are being tested in trial NCT06848478?
The interventions under investigation include: Exercise Intervention (BEHAVIORAL), Nutritional Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06848478?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06848478's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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