[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657314":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":74,"studyPopulation":74,"armGroups":82,"interventions":93,"overallOfficials":97,"centralContacts":105,"locations":112,"responsibleParty":156,"collaborators":159,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":74,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":74,"enrollmentInfo":174,"targetDuration":74,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":192,"whyStopped":74,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Universite du Quebec en Outaouais","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":74},[9,13,16,19,22,26,30,34,37],{"measure":10,"description":11,"timeFrame":12},"Recruitment rate","Number of patients contacted per month for eligibility screening. Success threshold: ≥ 6 patients\u002Fmonth","Over the recruitment period (up to 9 months)",{"measure":14,"description":15,"timeFrame":12},"Enrollment rate","Number of participants enrolled in the study per month",{"measure":17,"description":18,"timeFrame":12},"Study refusal rate","Percentage of eligible people who decline to participate",{"measure":20,"description":21,"timeFrame":12},"Eligibility rate","Percentage of screened individuals who meet eligibility criteria",{"measure":23,"description":24,"timeFrame":25},"Randomization acceptance rate","Percentage of eligible, consenting participants who accept randomization","At the time of enrollment",{"measure":27,"description":28,"timeFrame":29},"Retention rate by group","Percentage of participants retained in each study arm (target: ≥ 70%, per section 4.3)","From enrollment to the end of the intervention at 9 weeks",{"measure":31,"description":32,"timeFrame":33},"Intervention participation rate","Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)","Over the 9-week intervention period",{"measure":35,"description":36,"timeFrame":33},"EMA item response adherence rate","Percentage of completed ecological momentary assessment prompts on depressive symptoms (target: ≥ 60%, per section 4.3)",{"measure":38,"description":39,"timeFrame":40},"Intervention acceptability","Assessed using a study-specific questionnaire (anticipated acceptability at T1, retrospective acceptability at T2) and semi-structured individual interviews conducted online via Zoom, based on an established acceptability framework","At enrollment, at the end of the intervention (9 weeks), and during a follow-up interview within 4 weeks after the intervention ends",[42,46,50,53,56,59,62,65,68,72],{"measure":43,"description":44,"timeFrame":45},"Depressive symptom dynamics (EMA-MADRS)","Ecological Momentary Assessment version of the Montgomery-Åsberg Depression Rating Scale (EMA-MADRS), administered via the BEIWE smartphone application","Continuously throughout the 9-week intervention period",{"measure":47,"description":48,"timeFrame":49},"Depressive symptoms (Self report\u002FCES-D)","Center for Epidemiologic Studies Depression Scale (CES-D)","At baseline and at 9 weeks (end of intervention)",{"measure":51,"description":52,"timeFrame":49},"Depressive symptoms (clinician-rated\u002FMADRS)","Montgomery-Åsberg Depression Rating Scale (MADRS)",{"measure":54,"description":55,"timeFrame":49},"Anxiety symptoms (GAD-7)","Generalized Anxiety Disorder 7-item Scale (GAD-7)",{"measure":57,"description":58,"timeFrame":49},"Physical condition (6-minute walk test)","Distance walked (in meters) during a standardized 6-minute walk test on a 30-meter corridor, administered according to the American Thoracic Society protocol",{"measure":60,"description":61,"timeFrame":49},"Body mass index","Calculated from height and weight measured by a trained research assistant (kg\u002Fm²)",{"measure":63,"description":64,"timeFrame":49},"Waist circumference","Measured twice above the iliac crest using a measuring tape by a trained research assistant; the average of the two measurements is used (cm)",{"measure":66,"description":67,"timeFrame":49},"Physical activity and sedentary behavior","Simple Physical Activity Questionnaire (SIMPAQ)",{"measure":69,"description":70,"timeFrame":71},"Lifestyle habits","Standardized self-reported questionnaire","At baseline",{"measure":73,"description":70,"timeFrame":71},"Sociodemographic characteristics",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":6,"observationalModel":74,"timePerspective":74,"maskingInfo":78},"RANDOMIZED","PARALLEL",{"masking":79,"maskingDescription":74,"whoMasked":80},"SINGLE",[81],"OUTCOMES_ASSESSOR",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Physical Activity Intervention","EXPERIMENTAL","Participants will take part in an individually supervised physical activity program led by a trained kinesiologist, consisting of two 45-minute sessions per week for 9 weeks. The program will include aerobic activities (e.g., kickboxing, walking, running) and resistance exercises, selected based on each participant's preferences to support adherence. Participants will choose their preferred location (research center, community room, or outdoor park). Exercise intensity will be self-selected by participants during the first two weeks, then gradually progressed toward a moderate intensity target (50-60% of heart rate reserve), monitored using a heart rate monitor at each session.",[88],"Other: Supervised Physical Activity Program",{"label":90,"type":91,"description":92,"interventionNames":74},"Usual Care","NO_INTERVENTION","Participants will continue their usual care and will receive written documentation on the benefits of physical activity, along with information about community organizations offering physical activity and mental health resources. No supervised exercise program will be provided to this group.",[94],{"type":6,"name":95,"description":86,"armGroupLabels":96,"otherNames":74},"Supervised Physical Activity Program",[84],[98,102],{"name":99,"affiliation":100,"role":101},"Ahmed Jérôme Romain, Phd","Institut de santé mentale de Montréal\u002FUdM","PRINCIPAL_INVESTIGATOR",{"name":103,"affiliation":104,"role":101},"Sylvain Iceta, Phd","Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",[106],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},"Aurélie Baillot, Phd","CONTACT","819-595-3900","1995","aurelie.baillot@uqo.ca",[113,128,142],{"facility":114,"status":74,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Université du Québec en Outaouais","Gatineau","Quebec","J8X3X7","Canada","CA",{"type":121,"coordinates":122},"Point",[123,124],-75.70164,45.47723,{"lat":124,"lon":123},[127],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},{"facility":129,"status":74,"city":130,"state":116,"zip":131,"country":118,"countryCode":119,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Centre de recherche de l'Institut universitaire en santé mentale de Montréal","Montreal","H1N 3M5",{"type":121,"coordinates":133},[134,135],-73.58781,45.50884,{"lat":135,"lon":134},[138],{"name":99,"role":108,"phone":139,"phoneExt":140,"email":141},"514-343-6111","3898","aj.romain@umontreal.ca",{"facility":143,"status":74,"city":144,"state":116,"zip":145,"country":118,"countryCode":119,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)","Québec","G1V 4G5",{"type":121,"coordinates":147},[148,149],-71.21454,46.81228,{"lat":149,"lon":148},[152],{"name":103,"role":108,"phone":153,"phoneExt":154,"email":155},"418-656-8711","5346","sylvain.iceta.1@ulaval.ca",{"type":101,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Aurelie Baillot","Full Professor",[160,162,163],{"name":161,"class":6},"Institut du Savoir Montfort",{"name":104,"class":6},{"name":164,"class":6},"Université de Montréal","100657314","physical-activity-for-depressive-symptoms-in-adults-with-obesity-a-randomized-controlled-feasibility-trial-100657314",false,"NCT07836582","Physical Activity for Depressive Symptoms in Adults With Obesity: A Randomized Controlled Feasibility Trial","Effects of Physical Activity on the Dynamics of Depressive Symptoms in People Living With Obesity and Depressive Disorder: A Randomized Controlled Feasibility Trial","Inclusion Criteria:\n\n* Adult (≥ 18 years old)\n* Body mass index (BMI) ≥ 30 kg\u002Fm²\n* Mild to moderate depressive symptoms (Montgomery-Åsberg Depression -Rating Scale \\[MADRS\\] score ≥ 7 and \\\u003C 35)\n* Less than 90 minutes of moderate physical activity per week\n* Fewer than 2 structured physical activity sessions per week\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Absolute contraindication to physical activity (as determined by the Get Active Questionnaire)\n* Severe psychiatric comorbidity likely to interfere with participation or interpretation of results (bipolar affective disorder, schizoaffective disorder, schizophrenia, or severe post-traumatic stress disorder)\n* Unstable treatment or symptoms: any change to background treatment (pharmacological and\u002For psychotherapeutic) within the past 3 months, OR unstable symptoms over the past 3 months if not on medication","ALL","18 Years",{"count":175,"type":176},26,"ESTIMATED","INTERVENTIONAL",[179],"NA","The goal of this clinical trial is to learn whether a supervised physical activity program can be successfully carried out for adults living with obesity and depression, and whether people are willing to take part in this kind of research. The main questions it aims to answer are:\n\nCan researchers recruit enough participants and keep them in the study? Will participants attend the physical activity sessions? Does physical activity change how depression symptoms are connected to each other over time?\n\nResearchers expect that the study procedures and the physical activity program will be feasible and acceptable, based on goals set before the study began. Researchers also expect that physical activity will weaken the connections between depression symptoms over time and will lower depression symptoms overall. This second idea will be tested more fully in a future, larger trial.\n\nResearchers will compare a supervised physical activity program to usual care to see whether the program can be delivered as planned and is acceptable to participants.\n\nParticipants will:\n\n* Take part in a physical activity program led by a kinesiologist, twice a week for 9 weeks, or receive usual care plus information about physical activity and mental health support\n* Have a health check-up before and after the program\n* Answer short questions about their mood several times a day using a phone app\n* Take part in an interview after the program ends",[182,183],"Obesity & Overweight","Depression Disorders",[185,186,187,188,189,190,191],"Obesity","Depression","Physical activity","Feasibility study","Randomized controlled trial","Ecological momentary assessment","Multicenter study","NOT_YET_RECRUITING","2026-09-17",{"date":195,"type":196},"2026-09-23","ACTUAL",{"date":198,"type":176},"2027-01",{"date":200,"type":176},"2027-12",{"name":5,"class":6},3]