Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
3 other identifiers
interventional
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2026
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
Study Completion
Last participant's last visit for all outcomes
March 31, 2029
April 24, 2026
April 1, 2026
2.8 years
January 17, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Group differences in composite score of cardiometabolic health changes over time.
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 cardiometabolic health status.
Baseline, 6 weeks, and 12 weeks.
Secondary Outcomes (4)
Group differences in low-density lipoprotein (LDL) cholesterol (mg/dL) changes over time.
Baseline, 6 weeks, and 12 weeks.
Group differences in fow-mediated dilation (%) changes over time.
Baseline, 6 weeks, and 12 weeks.
Group differences in liver steatosis (dB/m) changes over time.
Baseline and 12 weeks.
Group differences in appendicular lean mass index changes over time.
Baseline, 6 weeks, and 12 weeks.
Study Arms (4)
Control
NO INTERVENTIONParticipants receive the standard of care for treating Class I and II obesity.
Exercise intervention
EXPERIMENTALIn 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
EXPERIMENTALIn 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.
Exercise and Nutritional Intervention
EXPERIMENTALIn addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female aged 13 to 17 years.
- Newly enrolled in a weight management program.
- Excessive weight: Class I obesity I (≥95% percentile to \< 120% of the 95th percentile), class II Obesity (≥120 to \<140% of the 95th percentile, or BMI ≥35 to \< 40 g/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.
You may not qualify if:
- Type 2 diabetes mellitus.
- Asthma that requires daily use of inhalers to keep symptoms under control.
- Asthma that requires the use of rescue inhalers (e.g., albuterol) \>2 days per week
- Exercise-induced asthma.
- Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
- Epilepsy.
- Cancer.
- Chronic kidney disease.
- Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).
- Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis).
- 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.
- Dislike of \> 1 study product assessed at the initial visit.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabet Borsheim, Ph.D
Arkansas Children's Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
February 27, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
April 24, 2026
Record last verified: 2026-04