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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

13 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Apr 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• No Intervention: Control
  Participants receive the standard of care for treating Class I and II obesity.
• Experimental: Exercise 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.
• Experimental: Nutritional 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.
• Experimental: Exercise and Nutritional Intervention
  In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.

Primary Outcome Measure

Group differences in composite score of cardiometabolic health changes over time. [ Time Frame: Baseline, 6 weeks, and 12 weeks. ]

Central Contacts

• Hannah Aston, MPH
  501-364-3055
  [email protected]
• Florêncio Sousa, Ph.D.
  [email protected]

Locations (2)

Find similar trials in Little Rock, AR

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