[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550425":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":31,"collaborators":19,"id":33,"slug":19,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":19,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":19,"enrollmentInfo":40,"targetDuration":19,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":51,"overallStatus":56,"whyStopped":19,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":19},{"fullName":5,"class":6},"Hopital Montfort","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Coaching Intervention","EXPERIMENTAL","This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.\n\nPA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.",[13],"Behavioral: Telehealth coaching for liver disease",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Telehealth coaching for liver disease",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Celine Fresne, MD","H[opital Montfort","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","6137464621","3588","celinefresne@montfort.on.ca",{"type":32,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100550425",false,"NCT06446908","Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity","Inclusion Criteria:\n\n* \\>18 years of age,\n* confirmed MASLD or MASH without cirrhosis\n* access to a computer with an internet connection\n\nExclusion Criteria:\n\n* liver disease from another cause,\n* the existence of cirrhosis on imaging or clinically,\n* weekly alcohol consumption over 50g,\n* having a contraindication to PA without medical clearance (the Get Active questionnaire from the Canadian Society for Exercise Physiology is used to determine if medical clearance is needed),\n* being already enrolled in a supervised exercise intervention or PA behaviour change intervention or currently meeting PA guidelines of 150 mins\u002Fweek\n* the need for a wheelchair, cane, walker, or other support(s) to move","ALL","18 Years",{"count":41,"type":42},12,"ESTIMATED","INTERVENTIONAL",[45],"NA","Steatosis is the building of fat in the liver. Steatotic liver disease (SLD) regroups MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH. MASH is a leading cause of liver transplantation in Canada. There is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA).\n\nIs a counselling intervention to help patients progressively engage in more PA a feasible and acceptable approach? Objectives. This proposal has three primary objectives: 1) To assess the feasibility of our PA counselling intervention (to be delivered online) with SLD patients; 2) To evaluate the acceptability of our intervention; 3) To evaluate the feasibility of the study methods\u002Fprocedures.\n\nMethodology. This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.\n\nPA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.\n\nBased on past studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.\n\nThe primary outcomes of the project are to evaluate the feasibility and acceptability of the trial and intervention. The secondary outcomes are Daily PA time and biological\u002Fimaging data evolution",[48,49,50],"Liver Steatosis","MASH","MASLD",[52,53,54,55],"Physical activity","coaching","telehealth","liver","NOT_YET_RECRUITING","2024-05-31",{"date":59,"type":60},"2024-06-06","ACTUAL",{"date":62,"type":42},"2024-08-01",{"date":64,"type":42},"2027-03-31",{"name":5,"class":6}]