Nctid:
NCT06617689
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009765", "term"=>"Obesity"}], "ancestors"=>[{"id"=>"D000050177", "term"=>"Overweight"}, {"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "asFound"=>"Obesity", "relevance"=>"HIGH"}, {"id"=>"M7502", "name"=>"Drinking Behavior", "relevance"=>"LOW"}, {"id"=>"M26186", "name"=>"Overweight", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>300}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2029-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-26", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Oral health", "timeFrame"=>"Baseline to 6 months postop. to 24 months postop.", "description"=>"Self-reported oral health, including OHIP14"}], "primaryOutcomes"=>[{"measure"=>"Drinking habits", "timeFrame"=>"Baseline to 6 months postop. to 24 months postop.", "description"=>"Reported intake plain water with no additives"}], "secondaryOutcomes"=>[{"measure"=>"Dental hygiene", "timeFrame"=>"Baseline to 6 months postop. to 24 months postop.", "description"=>"Self-reported dental hygiene"}, {"measure"=>"Level of knowledge", "timeFrame"=>"Baseline to 6 months postop. to 24 months postop.", "description"=>"Knowledge reflecting the central parts of the patient education"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Obesity", "Oral health"], "conditions"=>["Obesity", "Bariatric Surgery Candidate", "Norwegian Citizen"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.bar-oral.no", "label"=>"Patient education website in Norwegian, English and Polish"}]}, "descriptionModule"=>{"briefSummary"=>"The background for the study is that many bariatric surgery patients struggle with their oral health after bariatric surgery. This is probably related to both physiological changes and changes in eating and drinking patterns. In addition, many have reduced oral health even before surgery, and a significant proportion also have dental treatment anxiety, which also affects their ability to seek dental treatment. In sum, this is probably a patient group that may be at risk of oral pathology.\n\nParticipants in the study will be randomly allocated to different patient education programmes. The three interventions are:\n\n1. customised information on a website\n2. education delivered by a clinician\n3. distribution of free samples relevant to dental hygiene\n\nThe outcomes recorded are level of knowledge, drinking patterns, self-perceived oral health, and oral hygiene routines.", "detailedDescription"=>"Both caries and periodontitis are more prevalent among people with obesity. At the same time, we know that bariatric surgery is associated with poorer oral health expressed by caries, enamel erosion and short-term increased inflammation in the gums. Although we do not yet have evidence to determine causality, we suspect that oral health in bariatric surgery patients is further impaired by both systemic effects (hyposalivation, altered oral microbiome, reflux and vomiting) and by altered eating and drinking patterns after surgery (acid exposure with subsequent demineralisation of tooth enamel).\n\nThe patient's own diet and oral hygiene can be an opportunity to prevent or slow down such oral problems, but requires personal effort and must be a special focus in patient education.\n\nPatient education is one of the hospital's statutory duties, but the quality of patient education is rarely systematically investigated. This project investigates the effect of three alternative educational interventions on patients' drinking habits, oral hygiene routines, knowledge level and oral health. The three interventions are a website with adapted patient information, group-based education given by healthcare professionals, and distribution of relevant product samples to maintain oral hygiene. Patients are randomised between the different educational interventions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Eligible for bariatric surgery at a Norwegian hospital\n\nExclusion Criteria:\n\n* Insufficient language skills\n* Lack of consent competency"}, "identificationModule"=>{"nctId"=>"NCT06617689", "acronym"=>"BAR-VANNTANN", "briefTitle"=>"Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"St. Olavs Hospital"}, "officialTitle"=>"Effekt Av Pasientundervisning På Drikkevaner Og Munnhygiene Hos Pasienter Som Gjennomgår Fedmekirurgi", "orgStudyIdInfo"=>{"id"=>"705887"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm 1: Group-based teaching", "description"=>"In this arm, all three educational activities are included: Teaching (in a group), distribution of free dental hygiene samples, and advice on reading the customised website. This arm is compared to Arm 2.", "interventionNames"=>["Other: Various levels of patient education"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Arm 2: Comparator to Arm 1", "description"=>"In this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 1.", "interventionNames"=>["Other: Various levels of patient education"]}, {"type"=>"EXPERIMENTAL", "label"=>"Arm 3: Goodiebag", "description"=>"In this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 4.", "interventionNames"=>["Other: Various levels of patient education"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Arm 4: Comparator to Arm 3", "description"=>"In this arm, patients are adviced on reading the customised website. This arm is compared to Arm 3.", "interventionNames"=>["Other: Various levels of patient education"]}], "interventions"=>[{"name"=>"Various levels of patient education", "type"=>"OTHER", "description"=>"The three interventions:\n\nGROUP BASED TEACHING In groups of 8-12 patients, 30 minutes of standardised teaching is given. The teaching focuses in particular on the changes in diet and the impact this has on oral pH, enamel erosion and caries; recommended oral hygiene; and good drinking habits.\n\nWEBSITE Website providing recommendations for oral hygiene and drinking habits, as well as in depth information on the topic.\n\nDENTAL HYGIENE SAMPLES These are samples relevant for maintaining proper oral hygiene, distributed free, together with a description of how to use them.", "armGroupLabels"=>["Arm 1: Group-based teaching", "Arm 2: Comparator to Arm 1", "Arm 3: Goodiebag", "Arm 4: Comparator to Arm 3"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Magnus N Strømmen", "role"=>"CONTACT", "email"=>"magnus.strommen@stolav.no", "phone"=>"+4791701010"}], "overallOfficials"=>[{"name"=>"Magnus N Strømmen", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"St. Olavs Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"St. Olavs Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Helse Møre og Romsdal Hospital Trust", "class"=>"UNKNOWN"}, {"name"=>"Helse Nord-Trøndelag HF", "class"=>"OTHER"}, {"name"=>"Oslo University Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
