Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06848478

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Parent/child refusal to have blood drawn. * Refusal to authorize study investigators to access data from the clinical records.

Treatments and study arms

Exercise Intervention

Behavioral

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.

Nutritional Intervention

Behavioral

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.

Primary outcomes

Group differences in composite score of cardiometabolic health changes over time.Baseline, 6 weeks, and 12 weeks.

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Arkansas Children's Hospital Research Institute🇺🇸 Little Rock, Arkansas, United States

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Elisabet Borsheim, Ph.D.Contact

Email · Call 501-364-3053

Elisabet Borsheim, Ph.D.Principal Investigator

Arkansas Children's Nutrition Center🇺🇸 Little Rock, Arkansas, United States

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