An interventional study of Exercise Intervention and Nutritional Intervention in Obesity, sponsored by Arkansas Children's Hospital Research Institute. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Basic science
Among 12 studies in Obesity by Arkansas Children's Hospital Research Institute — 3 open to participants now, 5 under way, none of them phase 3. Obesity · Arkansas Children's Hospital Research Institute.
Among the 12 studies in Obesity by Arkansas Children's Hospital Research Institute, this one is the only one that started in 2026, is one of 9 with no phase, and was the 11th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →3 of the 12 studies in Obesity by Arkansas Children's Hospital Research Institute are open now, in 1 country. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 12 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2026.
Median enrollment 106 across the 9 interventional studies, 82 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.
1 of the studies in Obesity by Arkansas Children's Hospital Research Institute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06666257Arkansas Children's Hospital Research InstituteContinuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study | 2027-07-30 |
Among the 12 studies in Obesity by Arkansas Children's Hospital Research Institute, from their registry updates:
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:
Researchers will compare four groups to evaluate the independent and combined effects of structured exercise training and a structured fruit and vegetable dietary program:
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:
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:
The criteria were revised on the registry on Oct 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard of care for obesity.
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.
Behavioral: Exercise Intervention
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.
Behavioral: Nutritional Intervention
In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.
Behavioral: Exercise Intervention · Behavioral: Nutritional Intervention
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.
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.
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).
Time frame: Baseline, 6 weeks, and 12 weeks.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Mar 2029, 33 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 33 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Arkansas Children's Hospital Research Institute →