Tests exercise and fruit and vegetable smoothies in teens with obesity
Tests exercise and a produce-smoothie diet in teens with obesity.
Plain-language title generated from the registry record
Registry title: Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
Key facts
- Where
- Little Rock, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06848478, who can take part
Where in United States
- Arkansas Children's Hospital Research InstituteLittle Rock, United StatesTaking people
- Arkansas Children's Nutrition CenterLittle Rock, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arkansas Children's Hospital Research Institute
- Trial code
- NCT06848478
- Record updated
- 2 October 2026
- Original description
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:Read full original descriptionShow less
Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
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.
Inclusion: 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: Type 1 and Type 2 diabetes mellitus; 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; Asthma that requires the use of rescue inhalers (e.g., albuterol) >2 days per week; Exercise-induced asthma; 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.