[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465302":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":34,"locations":43,"responsibleParty":105,"collaborators":108,"id":114,"slug":23,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":23,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":23,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":23,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Manitoba","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"DBT + lifestyle","EXPERIMENTAL","Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.",[13,14],"Behavioral: Dialectical behavioral therapy","Behavioral: Lifestyle",{"label":16,"type":10,"description":17,"interventionNames":18},"Lifestyle alone","Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.",[14],{"label":20,"type":21,"description":22,"interventionNames":23},"Control","NO_INTERVENTION","Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","Dialectical behavioral therapy","Working with psychologists through DBT skills training.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"Lifestyle","Working with kinesiologist and registered dietician to improve lifestyle habits.",[9,16],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":23,"email":39},"Jon McGavock, 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MSc","Heidi.Virtanen@ahs.ca",{"name":59,"role":66,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":46,"city":68,"state":69,"zip":70,"country":50,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Winnipeg","Manitoba","R3E3P4",{"type":52,"coordinates":72},[73,74],-97.14704,49.8844,{"lat":74,"lon":73},[77,80,82,83],{"name":78,"role":37,"phone":79,"phoneExt":23,"email":39},"Jonathan McGavock, PhD","2047893591",{"name":81,"role":37,"phone":79,"phoneExt":23,"email":42},"Jana Apperley, MSc",{"name":78,"role":66,"phone":23,"phoneExt":23,"email":23},{"name":84,"role":66,"phone":23,"phoneExt":23,"email":23},"Emily Cameron, PhD",{"facility":86,"status":46,"city":87,"state":88,"zip":89,"country":50,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"McMaster University","Hamilton","Ontario","L8S 4L8",{"type":52,"coordinates":91},[92,93],-79.84963,43.25011,{"lat":93,"lon":92},[96,101,104],{"name":97,"role":37,"phone":98,"phoneExt":99,"email":100},"Katherine Morrison, MD, FRCP","905-521-2100","75926","kmorrison@mcmaster.ca",{"name":102,"role":37,"phone":23,"phoneExt":23,"email":103},"Autumn Lawrence, MSc","lawrea8@mcmaster.ca",{"name":97,"role":66,"phone":23,"phoneExt":23,"email":23},{"type":66,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Jon McGavock","Principal Investigator",[109,111],{"name":110,"class":6},"Diabetes Canada",{"name":112,"class":113},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100465302",false,"NCT05338944","Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)","Inclusion Criteria:\n\n* 14-17 years old\n* BMI z-score \\>1.4\n* signs of mild-moderate depression (PHQ-9 score 5-19)\n* willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* more than one health co-morbidity\n* being treated with medication for obesity\n* taking steroids\n* currently being treated for atypical antipsychotics\n* have an orthopedic injury or chronic illness that would prevent them from performing the intervention\n* experienced weight loss or enrolled in weight loss program in the six months prior to the study\n* they are currently and\u002For in the past 12 months have been prescribed any weight loss medication(s) including Ozempic\n* self reported history of alcoholism or drug abuse\n* history of self-harm or suicide attempts in the past 12 months\n* currently enrolled in psychotherapy or DBT\n* parents do not approve of you participating\n* unable to read, speak and understand English as translation will not be provided\n* unable\u002Funwilling to give assent\u002Fconsent",true,"ALL","14 Years","17 Years",{"count":124,"type":125},90,"ESTIMATED","INTERVENTIONAL",[128],"NA","This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.",[131,132],"Prevention","Type2Diabetes","2025-10-02",{"date":135,"type":136},"2025-10-07","ACTUAL",{"date":138,"type":136},"2023-01-14",{"date":140,"type":125},"2027-01-31",{"name":5,"class":6},3]