Nctid:
NCT06231667
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-01-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-01-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Health Literacy Level (School Age Children Health Literacy Scale)", "timeFrame"=>"before the implementation", "description"=>"Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels."}, {"measure"=>"Health Literacy Level (School Age Children Health Literacy Scale)", "timeFrame"=>"one month after the education", "description"=>"Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels."}, {"measure"=>"Health Literacy Level (School Age Children Health Literacy Scale)", "timeFrame"=>"three month after the education", "description"=>"Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["health literacy", "education", "adolescent"], "conditions"=>["Health Literacy Level"]}, "descriptionModule"=>{"briefSummary"=>"The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13 years old) students studying in a secondary school in Ankara. Power analysis was used to determine the sample size. A total of 80 adolescents who met the inclusion criteria were included in the sample."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"13 years", "minimumAge"=>"12 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Consent by the student's family\n* Volunteering to participate in the research\n* Having a low level of health literacy\n\nExclusion Criteria:\n\n* Read and write Turkish\n* Have a moderate or high level of health literacy\n* Physical/mental disability or illness"}, "identificationModule"=>{"nctId"=>"NCT06231667", "briefTitle"=>"The Effect of Health Literacy Education", "organization"=>{"class"=>"OTHER", "fullName"=>"Gazi University"}, "officialTitle"=>"The Effect of Health Literacy Education Given in Early Adolescence on Adolescents' Health Literacy", "orgStudyIdInfo"=>{"id"=>"2022/07.03.2022"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Education", "description"=>"The health literacy training was implemented in a total of 4 sessions, each session lasting 30 minutes, with an interval of one week. Various teaching methods and techniques were used in the trainings.", "interventionNames"=>["Other: Education"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control"}], "interventions"=>[{"name"=>"Education", "type"=>"OTHER", "description"=>"four training sessions were applied to the intervention group", "armGroupLabels"=>["Education"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Ankara", "country"=>"Turkey", "facility"=>"Gazi University", "geoPoint"=>{"lat"=>39.91987, "lon"=>32.85427}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gazi University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof. Dr., Dean of the Faculty of Nursing", "investigatorFullName"=>"Sultan Ayaz Alkaya", "investigatorAffiliation"=>"Gazi University"}}}}