Nctid:
NCT06616064
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002908", "term"=>"Chronic Disease"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M6147", "name"=>"Chronic Disease", "asFound"=>"Chronic Disease", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>148}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of green criteria on application feedback", "timeFrame"=>"between Day 0 and Month 1", "description"=>"The green criterioa corresponds to good compliance with health recommendations."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["brief intervention of lifestyle advice"], "conditions"=>["Chronic Disease"]}, "descriptionModule"=>{"briefSummary"=>"Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. Yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. But advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. To date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Treated for a stabilised chronic disease OR person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer.\n3. Contactable by telephone\n4. Affiliated to a social security scheme\n5. Having signed a free, informed and written consent.\n\nExclusion Criteria:\n\n1. Requiring psychiatric assessment\n2. Suffering from eating disorders\n3. Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)\n4. Suffering from a life-threatening condition within 5 years\n5. Suffering from a disabling condition (reduced activity with major restrictions)\n6. Unable to read\n7. Taking part in another psycho-behavioural nutritional intervention study\n8. Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor)."}, "identificationModule"=>{"nctId"=>"NCT06616064", "acronym"=>"CliniCAP", "briefTitle"=>"Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting", "organization"=>{"class"=>"OTHER", "fullName"=>"Rennes University Hospital"}, "officialTitle"=>"Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting", "orgStudyIdInfo"=>{"id"=>"35RC23_9738_CliniCAP"}, "secondaryIdInfos"=>[{"id"=>"2024-A01631-46", "type"=>"OTHER", "domain"=>"N°ID-RCB"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Experimental", "interventionNames"=>["Behavioral: personalised feedback and brief motivational", "Other: routine lifestyle advice", "Other: questionnaire CliniCAP"]}, {"type"=>"OTHER", "label"=>"Control", "interventionNames"=>["Other: routine lifestyle advice", "Other: questionnaire CliniCAP"]}], "interventions"=>[{"name"=>"personalised feedback and brief motivational", "type"=>"BEHAVIORAL", "description"=>"personalised feedback and brief motivational", "armGroupLabels"=>["Experimental"]}, {"name"=>"routine lifestyle advice", "type"=>"OTHER", "description"=>"routine lifestyle advice", "armGroupLabels"=>["Control", "Experimental"]}, {"name"=>"questionnaire CliniCAP", "type"=>"OTHER", "description"=>"questionnaire CliniCAP", "armGroupLabels"=>["Control", "Experimental"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35033", "city"=>"Rennes cedex 9", "country"=>"France", "facility"=>"CHU Rennes", "geoPoint"=>{"lat"=>48.11198, "lon"=>-1.67429}}], "centralContacts"=>[{"name"=>"Nicolas Mevel", "role"=>"CONTACT", "email"=>"dri@chu-rennes.fr", "phone"=>"02 99 28 25 55"}, {"name"=>"Anne Ganivet", "role"=>"CONTACT", "email"=>"anne.ganivet@chu-rennes.fr", "phone"=>"02 99 28 25 55"}], "overallOfficials"=>[{"name"=>"Romain Moirand", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"CHU Rennes"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Rennes University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
