Clinical trial NCT06848478: Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents with Obesity)
Official title: Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents with Obesity)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: exercise
obesity
diet
cardiometabolic
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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 (FV) improve cardiometabolic health in adolescents with obesity?
* Do exercise and FV diet together provide greater health benefits than either 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.


Eligibility 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.

Primary outcomes:
measure: Group differences in cardiorespiratory fitness (O₂ mL/kg/min) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in flow-mediated dilation (%) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in systolic blood pressure (mmHg) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in insulin sensitivity changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in percentage of body fat (%) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in liver steatosis (dB/m) changes over time.
timeFrame: Baseline, and 12 weeks.
measure: Group differences in fasting glucose (mg/dL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in fasting insulin (µU/mL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in diastolic blood pressure (mmHg) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in low-density lipoprotein (LDL) cholesterol (mg/dL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in high-density lipoprotein (HDL) cholesterol (mg/dL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in total cholesterol (mg/dL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in triglycerides (mg/dL) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in resting energy expenditure (kcal/day) changes over time.
timeFrame: Baseline, and 12 weeks.
measure: Group differences in time spent in moderate-to-vigorous physical activity (minutes/day) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
measure: Group differences in dietary intake quality (Healthy Eating Index) changes over time.
timeFrame: Baseline, 6 weeks, and 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Elisabet Borsheim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: