No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
12 – 17
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
120 (estimated)
Sponsor
Arkansas Children's Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for adolescents aged 13 to 17 who are struggling with obesity. Participants will take part in exercise programs and dietary coaching to see how these affect their health over 12 weeks.
Are You a Good Fit for This Trial?
Rules you outChronic kidney diseaseHormonal diseaseAutoimmune diseasesBleeding disordersChronic infections
You may be able to join if
I am between 13 and 17 years old.
I am newly enrolled in a weight management program.
I have class I or class II obesity.
I do less than 60 minutes of physical activity each day.
I eat less than 1.5 cups of fruit per day.
I eat less than 1.5 cups of vegetables per day.
I have a medical release.
You may not be able to join if
I have type 2 diabetes.
I have asthma that needs daily inhalers.
I use rescue inhalers more than twice a week.
I have exercise-induced asthma.
I have autism spectrum disorder.
I have epilepsy.
I have cancer.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 multidiscipli…
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.
Trial Locations
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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…
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.
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