[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581297":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":73,"collaborators":12,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":12,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":98,"whyStopped":12,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Arkansas Children's Hospital Research Institute","OTHER",[8,13,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Participants receive the standard of care for treating Class I and II obesity.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Behavioral: Exercise Intervention",{"label":20,"type":15,"description":21,"interventionNames":22},"Nutritional 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.",[23],"Behavioral: Nutritional Intervention",{"label":25,"type":15,"description":26,"interventionNames":27},"Exercise and 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.",[18,23],[29,33],{"type":30,"name":31,"description":16,"armGroupLabels":32,"otherNames":12},"BEHAVIORAL","Exercise Intervention",[25,14],{"type":30,"name":20,"description":21,"armGroupLabels":34,"otherNames":12},[25,20],[36],{"name":37,"affiliation":38,"role":39},"Elisabet Borsheim, Ph.D","Arkansas Children's Research Institute","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":12,"email":45},"Hannah Aston, MPH","CONTACT","501-364-3055","AstonHJ@archildrens.org",{"name":47,"role":43,"phone":12,"phoneExt":12,"email":48},"Florêncio Sousa, Ph.D.","JFDinizdesousa@uams.edu",[50,68],{"facility":5,"status":12,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Little Rock","Arkansas","72202","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-92.28959,34.74648,{"lat":60,"lon":59},[63,67],{"name":64,"role":43,"phone":65,"phoneExt":12,"email":66},"Elisabet Borsheim, Ph.D.","501-364-3053","EBorsheim@uams.edu",{"name":64,"role":39,"phone":12,"phoneExt":12,"email":12},{"facility":69,"status":12,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":72,"contacts":12},"Arkansas Children's Nutrition Center",{"type":57,"coordinates":71},[59,60],{"lat":60,"lon":59},{"type":74,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100581297","level-up-the-combined-and-independent-effects-of-exercise-training-and-dietary-enhancement-on-cardiometabolic-health-in-adolescents-with-obesity-100581297",false,"NCT06848478","Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health in Adolescents With Obesity)","Inclusion Criteria:\n\n* Male or female aged 13 to 17 years.\n* Newly enrolled in a weight management program.\n* Excessive weight: Class I obesity I (≥95% percentile to \\\u003C 120% of the 95th percentile), class II Obesity (≥120 to \\\u003C140% of the 95th percentile, or BMI ≥35 to \\\u003C 40 g\u002Fm2).\n* Less than 60 min\u002Fday of moderate to vigorous physical activity.\n* Fruit intake ≤ 1.5 cup equivalent per day.\n* Vegetable intake ≤ 1.5 cup equivalent per day.\n* Medical release.\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus.\n* Asthma that requires daily use of inhalers to keep symptoms under control.\n* Asthma that requires the use of rescue inhalers (e.g., albuterol) \\>2 days per week\n* Exercise-induced asthma.\n* Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).\n* Epilepsy.\n* Cancer.\n* Chronic kidney disease.\n* Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).\n* Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis).\n* Bleeding disorders (e.g., hemophilia).\n* Chronic infections (e.g., HIV, hepatitis B, hepatitis C).\n* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.\n* Pregnancy.\n* Dislike of \\> 1 study product assessed at the initial visit.\n* Parent\u002Fchild refusal to have blood drawn.\n* Refusal to authorize study investigators to access data from the clinical records.","ALL","13 Years","17 Years",{"count":85,"type":86},120,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity. The main questions it aims to answer are:\n\n* Does exercise improve cardiometabolic health in adolescents with obesity?\n* Does enriching the diet with fruits and vegetables improve cardiometabolic health in adolescents with obesity?\n* Do exercise and a fruit and vegetable diet together provide greater health benefits than either one alone in adolescents with obesity?\n\nResearchers will compare four groups to see how exercise and diet impact health:\n\n* Standard Care Group: Receives the usual care for obesity.\n* Exercise Group: Receives weekly exercise coaching and participates in a 12-week exercise program.\n* Diet Group: Receives weekly dietary coaching and eats a diet enriched with fruits and vegetables for 12 weeks.\n* Combined Exercise and Diet Group: Receives both exercise and dietary programs, namely weekly exercise and dietary coaching, participation in a 12-week exercise program, and daily consumption of fruits and vegetables for 12 weeks.\n\nDuring the 12-week study, participants will attend three study visits to:\n\n* Provide blood, stool, and urine samples.\n* Answer questions about health, sleep, diet, and physical activity.\n* Undergo body scans to measure fat, lean, and bone mass.\n* Complete blood vessel function and liver fat content assessments.\n* Assess resting exergy expenditure.\n* Complete fitness tests.\n* Wear a fitness tracker to monitor physical activity and sleep patterns.",[92],"Obesity",[94,95,96,97],"exercise","obesity","diet","cardiometabolic","NOT_YET_RECRUITING","2026-04-22",{"date":101,"type":102},"2026-04-24","ACTUAL",{"date":104,"type":86},"2026-06-01",{"date":106,"type":86},"2029-03-31",{"name":5,"class":6},2]