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

Launched by ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE · Feb 24, 2025

Keywords

ClinConnect Summary

The "Level Up!" trial is looking to understand how exercise and healthy eating can improve the health of teenagers who are dealing with obesity. Researchers want to find out if regular exercise, a diet rich in fruits and vegetables, or a combination of both can help improve heart and metabolic health in adolescents. Participants will be divided into four groups: one will receive standard care, another will get exercise coaching and follow a 12-week exercise program, a third will focus on dietary changes with weekly coaching to eat more fruits and vegetables, and the last group will do both exercise and diet changes together.

To join the study, participants need to be between 13 to 17 years old, enrolled in a weight management program, and have specific weight criteria. During the 12 weeks, they will visit the study center three times to provide samples, answer questions about their health, and undergo various health assessments, including fitness tests and body scans. This study is not yet recruiting, but it aims to provide important insights into how lifestyle changes can benefit teenagers struggling with obesity.

Gender

ALL

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.