[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512586":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":31,"studyPopulation":23,"armGroups":32,"interventions":43,"overallOfficials":23,"centralContacts":48,"locations":55,"responsibleParty":70,"collaborators":23,"id":72,"slug":23,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":95,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Elsan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Rates of patients lost to follow up","Rates of patients lost to follow up measured in both arms and compared 4 years after randomization","4 years",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"The evolution of quality of life, self-esteem and perceived health compared to baseline","The evolution of quality of life, self-esteem and perceived health will be measured using the Duke questionnaire, and will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization","1,2,3 and 4 years",{"measure":19,"description":19,"timeFrame":20},"Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization","1,2 and 3 years",{"measure":22,"description":22,"timeFrame":17},"Change in waist circumference (cm) compared with the baseline measurement will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","The study concerns patients who ended the 6 months obesity treatment program proposed by the center. At the end of this 6 months care phase, patients will be randomized in 2 groups (ratio 1:1).\n\nThe intervention will be and addition of telemedicine quarterly follow up (remote motivational interviews) to the standard multidisciplinary follow-up post care management program","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE","Obesity became a major public health issue in France. In 2019, obesity represented 5% of annual costs in health and was responsible of a 2.7% lost in France's Gross Domestic Product. In the scop of french health ministry's recommendations for obese patients'care and the territorial healthcare program; Saint-François' hospital set up 3 healthcare programs: \"medical obesity\",\" interventional\" and \"post surgery\". A very few number of studies aim to asse the efficacity of a long-term telemedicine follow-up after a bariatric medical care program. STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of a long term, telemedical, personalized, educative quarterly, follow-up (4 years follow up), in addition to standard follow-up, strengthening an Obesity program in Berry (FRANCE). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Standard multidisciplinary follow-up reinforced with telemedicine","EXPERIMENTAL","Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)",[38],"Other: Quarterly remote motivational interviews",{"label":40,"type":41,"description":42,"interventionNames":23},"Standard multidisciplinary follow up","NO_INTERVENTION","Standard annual multidisciplinary follow-up without telemedicine follow up",[44],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":23},"Quarterly remote motivational interviews","Remote motivational interview will be in the form of quarterly telephone call (at 3, 6 and 9 months after the start of annual follow up; the patient is seen again at 12 months as part of the annual follow-up) and this for 4 years. It will be performed by medical staff trained in motivational interviewing and who have completed at least 40 hours training in therapeutic education",[34],[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Françoise LEVITTA, MD","CONTACT","06 78 57 01 42","+33","françoise.levitta@orange.fr",[56],{"facility":57,"status":23,"city":58,"state":23,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Clinique Saint-François","Châteauroux","36000","France","FR",{"type":63,"coordinates":64},"Point",[65,66],1.69362,46.81248,{"lat":66,"lon":65},[69],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},{"type":71,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100512586",false,"NCT05954377","Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program","Prospective, Single-center, Randomized, Open Label Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up, Strengthening an Obesity Program in Berry (FRANCE)","STROBERRY","Inclusion Criteria:\n\n* Woman or Male aged from 18 to 60 years old included\n* Patient in obesity (BMI\\> or = 30)\n* Patient who has completed a multidisciplinary medical program for obesity management, as a first- or second-line intention (after initial obesity management) at the investigating center\n* Affiliation to a social security scheme\n* Patient informed of the study and who had signed the informed consent form\n\nNon Inclusion Criteria:\n\n* Management of obesity within the framework of an exclusively interventional program, without redirection to a medical program\n* Managing obesity as part of a post-operative program\n* Pregnant or breastfeeding women\n* Patients deprived of liberty\n* Patients under legal protection","ALL","18 Years","60 Years",{"count":83,"type":84},116,"ESTIMATED","INTERVENTIONAL",[87],"NA","STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program",[90],"Obesity",[92,93,94],"obesity","public health","telemedicine","NOT_YET_RECRUITING","2024-04-23",{"date":98,"type":99},"2024-04-24","ACTUAL",{"date":101,"type":84},"2024-09",{"date":103,"type":84},"2030-03",{"name":5,"class":6},1]