ObesityNCT06848478
Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
A study testing Exercise Intervention and Nutritional Intervention in people with Obesity, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise Intervention and Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Florêncio Sousa, Ph.D. contact
United States2 sites, 2 recruiting
- Recruiting
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Elisabet Borsheim, Ph.D., 501-364-3053, EBorsheim@uams.edu
Elisabet Borsheim, Ph.D.
- Recruiting
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
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?
Read more
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.
Read the detailed description
The Level Up! study has a 12-week intervention period. Assessments are planned at baseline, week 6, and week 12 at the Arkansas Children's Nutrition Center (ACNC). Some procedures may be completed at home or split across more than one day. On-site assessments may last up to six hours, and some procedures require participants to fast, with water permitted after midnight. Trained personnel will conduct assessments according to standardized procedures.
Assessments include:
- Medical history, vital signs, and anthropometric measurements, including height, body mass, sitting height, and body circumferences.
- Whole-body and regional body composition measured by dual-energy X-ray absorptiometry (DXA), including fat, lean, and bone mass.
- Fasting venous blood, spot and 24-hour urine, and stool sample collection.
- Continuous glucose monitoring using an interstitial glucose sensor.
- Brachial artery flow-mediated dilation assessed by ultrasound.
- Liver steatosis and stiffness assessed by FibroScan, and skin carotenoid levels measured using the Veggie Meter.
- Resting metabolic rate measured by indirect calorimetry.
- Cardiorespiratory fitness assessed by cardiopulmonary exercise testing (CPET) on a cycle ergometer, with breath-by-breath gas-exchange measurement to determine peak oxygen uptake.
- Knee extensor and flexor strength assessed by isokinetic dynamometry, and handgrip strength measured using a digital handheld dynamometer.
- Physical activity and sleep monitored using accelerometers worn at the wrist and hip, and dietary intake assessed using three-day food records.
- Substrate utilization assessed during a mixed-meal tolerance test (MMTT) using indirect calorimetry.
- Questionnaires assessing sleep, anxiety and depressive symptoms, substance use, physical activity enjoyment, socioeconomic background, and pubertal status.
- Conditions
- Obesity
- Being tested
- Exercise Intervention, Nutritional Intervention
- Keywords
- exercise, obesity, diet, cardiometabolic
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week.
Nutritional InterventionBehavioural
In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive standard of care for obesity. |
| Exercise intervention | Experimental | In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week. Receives: Behavioral: Exercise Intervention |
| Nutritional Intervention | Experimental | In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables. Receives: Behavioral: Nutritional Intervention |
| Exercise and Nutritional Intervention | Experimental | In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms. Receives: Behavioral: Exercise Intervention; Behavioral: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in changes in the composite cardiometabolic health score over time
The primary outcome is a composite cardiometabolic health score. It is calculated as the mean of standardized z-scores for 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).
Measured: Baseline, 6 weeks, and 12 weeks.
Secondary outcomes (4)
Group differences in changes in low-density lipoprotein (LDL) cholesterol (mg/dL) over time
Measured: Baseline, 6 weeks, and 12 weeks.
Group differences in changes in brachial artery flow-mediated dilation (%) over time
Measured: Baseline and 12 weeks.
Group differences in changes in liver steatosis (dB/m) over time
Measured: Baseline and 12 weeks.
Group differences in changes in appendicular lean mass index (kg/m²) over time
Measured: Baseline, 6 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start4 Jun 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, Ph.D, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848478
- Sponsor's protocol ID
- 287133
- Other IDs
- USDA/ARS 6026-10700-001-000D, U1111-1339-4285
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)
- ClinicalTrials.gov ID
- NCT06848478
- Acronym / sponsor ID
- 287133
- Conditions
- Obesity
- Keywords
- exercise, obesity, diet, cardiometabolic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Level Up! study has a 12-week intervention period. Assessments are planned at baseline, week 6, and week 12 at the Arkansas Children's Nutrition Center (ACNC). Some procedures may be completed at home or split across more than one day. On-site assessments may last up to six hours, and some procedures require participants to fast, with water permitted after midnight. Trained personnel will conduct assessments according to standardized procedures.
Assessments include:
- Medical history, vital signs, and anthropometric measurements, including height, body mass, sitting height, and body circumferences.
- Whole-body and regional body composition measured by dual-energy X-ray absorptiometry (DXA), including fat, lean, and bone mass.
- Fasting venous blood, spot and 24-hour urine, and stool sample collection.
- Continuous glucose monitoring using an interstitial glucose sensor.
- Brachial artery flow-mediated dilation assessed by ultrasound.
- Liver steatosis and stiffness assessed by FibroScan, and skin carotenoid levels measured using the Veggie Meter.
- Resting metabolic rate measured by indirect calorimetry.
- Cardiorespiratory fitness assessed by cardiopulmonary exercise testing (CPET) on a cycle ergometer, with breath-by-breath gas-exchange measurement to determine peak oxygen uptake.
- Knee extensor and flexor strength assessed by isokinetic dynamometry, and handgrip strength measured using a digital handheld dynamometer.
- Physical activity and sleep monitored using accelerometers worn at the wrist and hip, and dietary intake assessed using three-day food records.
- Substrate utilization assessed during a mixed-meal tolerance test (MMTT) using indirect calorimetry.
- Questionnaires assessing sleep, anxiety and depressive symptoms, substance use, physical activity enjoyment, socioeconomic background, and pubertal status.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard of care for obesity. |
| Exercise intervention | Experimental | Behavioral: Exercise InterventionIn addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week. |
| Nutritional Intervention | Experimental | Behavioral: Nutritional InterventionIn addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables. |
| Exercise and Nutritional Intervention | Experimental | Behavioral: Exercise Intervention, Behavioral: Nutritional InterventionIn addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionIn addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week. | Behavioural | Exercise and Nutritional Intervention, Exercise intervention |
| Nutritional InterventionIn addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables. | Behavioural | Exercise and Nutritional Intervention, Nutritional Intervention |
Primary outcome
Group differences in changes in the composite cardiometabolic health score over time
Time frame: Baseline, 6 weeks, and 12 weeks.
The primary outcome is a composite cardiometabolic health score. It is calculated as the mean of standardized z-scores for 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).
4 secondary outcomes
Group differences in changes in low-density lipoprotein (LDL) cholesterol (mg/dL) over time
Time frame: Baseline, 6 weeks, and 12 weeks.
Group differences in changes in brachial artery flow-mediated dilation (%) over time
Time frame: Baseline and 12 weeks.
Group differences in changes in liver steatosis (dB/m) over time
Time frame: Baseline and 12 weeks.
Group differences in changes in appendicular lean mass index (kg/m²) over time
Time frame: Baseline, 6 weeks, and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florêncio Sousa, Ph.D. contact
Elisabet Borsheim, Ph.D principal investigator
Arkansas Children's Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Nutritional Intervention in people with Obesity, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Aston, MPH (501-364-3055, AstonHJ@archildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in changes in the composite cardiometabolic health score over time (time frame: Baseline, 6 weeks, and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.