[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581598":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":66,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":33,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":49,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"McMaster University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"BLP, then BLP+semaglutide","ACTIVE_COMPARATOR","Group A will engage in a BLP alone for the first six months of the study, then receive BLP and semaglutide (Wegovy®) for the last six months of the study, beginning with 0.25 mg subcutaneously weekly and being titrated every four weeks up to a maximum of 2.4 mg in approved doses 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg.",[13,14],"Drug: Semaglutide Pen Injector","Behavioral: Behavioural Lifestyle Program (BLP)",{"label":16,"type":17,"description":18,"interventionNames":19},"BLP and semaglutide","EXPERIMENTAL","In addition to BLP, Group B will receive semaglutide (Wegovy®) titrated to maximal dose tolerated, in approved doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg subcutaneously weekly for 6 months .",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide Pen Injector","Semaglutide will be delivered by a subcutaneous injection using an injectable pen once weekly. Semaglutide is formulated with 5 approved doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg). Treatment will commence with the lowest dose and will be increased every 4 weeks to the maximum tolerable dose where they will remain for the remainder of the treatment. Participants who are taking the drug will have monthly visits to assess any adverse events, dose titration and drug adherence.",[16,9],[27],"Wegovy®",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Behavioural Lifestyle Program (BLP)","The BLP will be delivered by the Growing Healthy Weight Management (GHWM) pediatric program at McMaster Children's Hospital. GHWM is a family-based program addressing health behaviours (nutritional pattern and eating behaviours, physical activity, sedentary time and sleep) and physical and mental health issues. In Year 1, the program typically includes 2 group sessions and monthly individualized sessions with the participant and their family. The interdisciplinary weight management team is comprised of a registered dietician, exercise physiologist, kinesiologist, social worker and\u002For psychologist, general pediatrician and pediatric endocrinologists.",[16,9],null,[35],{"name":36,"affiliation":5,"role":37},"Katherine M Morrison, MD FRCPC","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Athena Flores Miranda","CONTACT","905-525-9140","21407","joulemrs@mcmaster.ca",{"name":46,"role":41,"phone":42,"phoneExt":43,"email":44},"Aaron Thomas, PhD",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Hamilton","Ontario","L8S 4L8","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-79.84963,43.25011,{"lat":59,"lon":58},[62,63,65],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":64,"role":41,"phone":42,"phoneExt":43,"email":44},"Aaron Thomas",{"name":36,"role":37,"phone":33,"phoneExt":33,"email":33},{"type":67,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[69,72],{"name":70,"class":71},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":73,"class":6},"Diabetes Canada","100581598","phase-4-joule---metabolic-adaptation-to-weight-loss-in-response-to-a-behavioural-lifestyle-program-with-or-without-semaglutide-in-adolescents-with-obesity-100581598",false,"NCT06852391","JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity","JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity - a Randomized Controlled Trial","JOULE-MARS","Inclusion Criteria:\n\n* Youth aged 12-17 years\n* Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median)\n* Enrolled in Growing Health Weight Management or Next Step pediatric clinics (ie. have at least one year of the program remaining).\n\nExclusion Criteria:\n\n* Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight \\>300lb. Ineligible for imaging visit only.\n* Use of atypical anti-psychotics.\n* Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.)\n* Elevated alanine aminotransferase (ALT) \\> 5 x upper range of normal at screening.\n* Use of glucose lowering or any anti-obesity medication in the previous 3 months.\n* Known monogenic, syndromic or hypothalamic causes of obesity.\n* Diagnosis of type 1 or 2 diabetes mellitus.\n* Prior bariatric surgery or liver transplantation.\n* Alcohol intake exceeding 3 drinks per week or reported cannabis use.\n* Recent history of cigarette smoking (previous 3 months) - ineligible for imaging only.\n* History or family history of multiple endocrine neoplasia 2 or medullary thyroid cancer.\n* History of pancreatitis.\n* Presence of untreated endocrine disorder.\n* History of an eating disorder and \u002F or history of suicidal ideation\n* History of a cardiac condition that precludes exercise testing or unable to have exercise testing done in the GHWM pediatric clinic, inability to use a cycle ergometer.\n\nParticipant who does not have a peak power value obtained in the GHWM pediatric clinic\n\nFemale who is pregnant, breast-feeding or intends to become pregnant.\n\nFemale who refuses to use a means of contraception if sexually active.\n\nParticipation in any interventional clinical study within 90 days before screening.","ALL","12 Years","17 Years",{"count":86,"type":87},74,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the implementation of BLP alone for 6 months leads to less adaptive thermogenesis.",[93],"Obesity (Disorder)",[95,96,97,98,99,100,101,102,103,104,105,106,107,108],"Adaptive Thermogenesis","obesity","semaglutide","GLP-1 agonist","weight loss","Energy expenditure","Whole room calorimetry","MRI","MR elastography","Cold exposure","Liver stiffness","Brown adipose tissue","Pediatric","Quality of life","2026-01-13",{"date":111,"type":112},"2026-01-14","ACTUAL",{"date":114,"type":112},"2025-06-18",{"date":116,"type":87},"2027-12-31",{"name":5,"class":6},1]