Back to search results

Level Up! Study: Exercise and Diet for Adolescent Obesity

The Level Up! study is looking at how exercise and a diet rich in fruits and vegetables can improve the health of teenagers (ages 13-17) who have obesity. Researchers want to see if exercise alone, a special diet alone, or a combination of both can lead to better heart and metabolic health. You could join if you are 13-17, newly enrolled in a weight management program, have certain levels of obesity, and don't get much physical activity or eat many fruits. The study will measure changes in a combined score of heart and metabolic health over 12 weeks. The current recruitment status is unclear.

Study design
This is a 12-week randomized controlled trial with 120 participants. Participants will be assigned to one of four groups: standard care, exercise, dietary, or combined exercise and dietary intervention.
What's involved
You would attend three assessment visits at baseline, week 6, and week 12. These visits include measurements like body composition (DXA scan), blood tests, and tests for heart function and fitness.
Compensation
Not stated in the trial record.
Follow-up
Your health will be measured at baseline, 6 weeks, and 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06848478

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

Not Yet Recruiting
NAAges 13–17InterventionalBasic science
Arkansas Children's Hospital Research Institute
~120 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Exercise InterventionNutritional Intervention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Group differences in composite score of cardiometabolic health changes over time.
Measured over Baseline, 6 weeks, and 12 weeks.

Conditions

Obesity

Explore related trials

Obesity

Where it's being run

2 sites across 1 states
Arkansas2

Study leadership

  • Elisabet Borsheim, Ph.D · PRINCIPAL_INVESTIGATOR · Arkansas Children's Research Institute

Who to contact

Hannah Aston, MPH
[email protected]
501-364-3055
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Group differences in composite score of cardiometabolic health changes over time.Baseline, 6 weeks, and 12 weeks.

    The primary outcome is a composite score of cardiometabolic health status. The score is calculated as the mean of specific z-scores for the following markers: fasting triglycerides (mg/dL), total cholesterol/HDL-cholesterol ratio, HOMA2-IR, systolic blood pressure (mmHg), fat-mass-index \[whole-body fat mass (kg)/height² (m²)\], and inverse peak oxygen uptake (mL O₂/kg/min). The composite score is computed as the mean of the standardized z-scores for each marker, providing an overall measure of cardiometabolic health status.