Exercise + Nutrition for Obesity

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byElisabet Borsheim, Ph.D

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Arkansas Children's Hospital Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for adolescents with obesity. Participants should be willing to undergo exercise or dietary coaching, provide samples, and have their body composition and health monitored. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Medical release

Less than 60 min/day of moderate to vigorous physical activity

Newly enrolled in a weight management program

+4 more

Exclusion Criteria

Parent/child refusal to have blood drawn

I use daily asthma inhalers to control my symptoms.

I use my asthma rescue inhaler more than twice a week.

+14 more

Participant Groups

The study tests the effects of exercise, a diet rich in fruits and vegetables (FV), or both on cardiometabolic health in obese adolescents. It compares four groups: standard care, exercise only, FV diet only, and combined exercise plus FV diet over 12 weeks.

4Treatment groups

Experimental Treatment

Active Control

Group I: Nutritional InterventionExperimental Treatment1 Intervention

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.

Group II: Exercise interventionExperimental Treatment1 Intervention

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.

Group III: Exercise and Nutritional InterventionExperimental Treatment2 Interventions

In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.

Group IV: ControlActive Control1 Intervention

Participants receive the standard of care for treating Class I and II obesity.