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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 12-week study tests whether adding exercise, a daily fruit and vegetable smoothie program, or both to usual obesity care improves heart and body health. It is for teens ages 12 to 17 with obesity who are in the COACH clinic weight management program.

The goal of this clinical trial is to determine whether adding structured exercise training and a structured fruit and vegetable dietary program to standard multidisciplinary obesity care improves cardiometabolic health in adolescents with obesity enrolled in a weight management program. The main questions it aims to answer are: * Does adding structured exercise training to standard multidisciplinary obesity care improve cardiometabolic health? * Does adding a structured fruit and vegetable dietary program to standard multidisciplinary obesity care improve cardiometabolic health? * Does combining structured exercise training and the fruit and vegetable dietary program with standard multidisciplinary obesity care improve cardiometabolic health? Researchers will compare four groups to evaluate the independent and combined effects of structured exercise training and a structured fruit and vegetable dietary program: * Standard Care Group: Receives standard multidisciplinary obesity care. * Exercise Group: Receives standard care plus a 12-week supervised, structured multicomponent exercise program, weekly exercise counseling, and continuous physical activity monitoring using a tracker. * Dietary Group: Receives standard care plus a 12-week fruit and vegetable enrichment program involving daily smoothie consumption designed to provide one cup of fruit and one cup of vegetables per day, using frozen smoothie ingredient packages delivered to participants' homes, and weekly dietary coaching. * Combined Exercise and Dietary Group: Receives standard care plus both the structured exercise and fruit and vegetable dietary programs. During the 12-week study, participants will complete assessments at baseline, week 6, and week 12. Some procedures may be completed at home or split across more than one day. Assessments may include: * Providing blood, urine, and stool samples. * Completing questionnaires about health, sleep, diet, physical activity, mood, and other health behaviors. * Undergoing body-composition scans to measure fat, lean, and bone mass. * Completing blood-vessel function, liver-fat, and skin-carotenoid assessments. * Completing continuous glucose monitoring. * Assessing resting energy expenditure. * Completing fitness and muscle-strength tests. * Completing a standardized meal-based metabolic assessment. * Completing 3-day dietary records. * Wearing activity and sleep monitors to assess physical activity and sleep patterns.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 17 years old.
  • Be enrolled in the COACH clinic weight management program.
  • Have class I, II, or III obesity, based on body mass index (BMI), a measure using height and weight.
  • Get less than 60 minutes a day of activity that makes you breathe harder.
  • Eat no more than 1.5 cups of fruit a day.
  • Eat no more than 1.5 cups of vegetables a day.
  • Have approval from the COACH clinic to exercise.

Who can't join

  • Have type 1 or type 2 diabetes.
  • Have asthma caused by exercise, or need a quick-relief asthma inhaler more than 2 days a week.
  • Have epilepsy (a seizure disorder), cancer, or long-term kidney disease.
  • Have a bleeding disorder, such as hemophilia, or a long-term infection, such as HIV or hepatitis B or C.
  • Have another health condition or take medicine that the study team thinks could affect the results.
  • Be pregnant, as shown by a urine test.
  • Dislike all the study's smoothie choices at the first visit.
  • The teen or parent refuses blood draws, or does not allow the study team to access COACH clinic records.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria * Male or female aged 12 to 17 years. * Enrolled in the weight management program at the COACH clinic. * Class I obesity (≥95th percentile to \<120% of the 95th percentile), class II obesity (≥120% to \<140% of the 95th percentile, or BMI ≥35 to \<40 kg/m²), and class III obesity (≥140% of the 95th percentile, or BMI ≥40 kg/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 from COACH clinic to perform exercise. Exclusion criteria * Type 1 and Type 2 diabetes mellitus. * Asthma that requires the use of rescue inhalers (e.g., albuterol) \>2 days per week. * Exercise-induced asthma. * Epilepsy. * Cancer. * Chronic kidney disease. * 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 (urine test). * Dislike of all the fruit and vegetable smoothie options pre-defined by the study team at the initial visit. * Parent/child refusal to have blood drawn. * Refusal to authorize study investigators to access data from the COACH clinic.

Study sites (2)

AR