Nctid:
NCT06614075
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D044343", "term"=>"Overnutrition"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}, {"id"=>"D001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "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"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1840}, "targetDuration"=>"1 Day", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-01-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-06-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Finnish Diabetes Risk Score (FINDRISC)", "timeFrame"=>"Baseline", "description"=>"Scores can range from a minimum of 0 to a maximum of 26 points. According to the FINDRISC scoring system, scores are classified as follows: a score of less than 7 indicates low risk, 7-11 indicates mild risk, 12-14 indicates moderate risk, 15-20 indicates high risk, and a score of less than 20 indicates very high risk."}, {"measure"=>"Healthy eating index-2015 (HEI-2015)", "timeFrame"=>"Baseline", "description"=>"A 24 hour dietary recall was used to assess dietary intake. Nutrient intake obtained from dietary recalls were evaluated using Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 9). The HEI- 2015 and its sub-scores are calculated based on the quantity of food and nutrient intake per 1,000 kilocalories consumed by individuals. HEI-2015 scores range from a minimum of 0 to a maximum of 100. Based on the calculated scores, a score greater than 80 indicates good diet quality, a score between 51 and 80 is categorized as moderate diet quality, and a score of 50 or less is defined as poor diet quality."}], "secondaryOutcomes"=>[{"measure"=>"Sociodemographic characteristics", "timeFrame"=>"Baseline", "description"=>"number and percentage"}, {"measure"=>"Lifestyle habits", "timeFrame"=>"Baseline", "description"=>"number and percentage"}, {"measure"=>"Body weight", "timeFrame"=>"Baseline", "description"=>"Body weight in kg"}, {"measure"=>"Height", "timeFrame"=>"Baseline", "description"=>"Height in cm"}, {"measure"=>"Waist circumference", "timeFrame"=>"Baseline", "description"=>"waist circumference in cm"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["diabetes mellitus", "obesity", "diet"], "conditions"=>["Overweight", "Obesity"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. The main question it aims to answer is:\n\nIs there a relationship between diabetes risk and diet quality in overweight and obese individuals?\n\nParticipants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. FINDRISC questionnaire will be applied to assess diabetes risk."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"64 years", "minimumAge"=>"19 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Community sample in Ankara, Turkey", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Body mass index (BMI) ≥25 kg/m²\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Psychiatric disorders\n* Pregnant and lactating"}, "identificationModule"=>{"nctId"=>"NCT06614075", "briefTitle"=>"Diet Quality and Diabetes Risk in Overweight and Obese Adults", "organization"=>{"class"=>"OTHER", "fullName"=>"Ankara Yildirim Beyazıt University"}, "officialTitle"=>"The Relationship Between Sociodemographic Characteristics, Lifestyle, and Diet Quality With Diabetes Risk in Overweight and Obese Adults", "orgStudyIdInfo"=>{"id"=>"AnkaraYBU-KARAKAYA002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Adults", "description"=>"Overweight and obese adults", "interventionNames"=>["Behavioral: Questionnaire and anthropometric measurement"]}], "interventions"=>[{"name"=>"Questionnaire and anthropometric measurement", "type"=>"BEHAVIORAL", "description"=>"Questionnaire including sociodemographic characteristics, lifestyle habits, body weight, height, dietary assessment and diabetes risk; Anthropometric measurement including waist circumference", "armGroupLabels"=>["Adults"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06760", "city"=>"Ankara", "state"=>"Çubuk", "country"=>"Turkey", "facility"=>"Ankara Yıldırım Beyazıt University", "geoPoint"=>{"lat"=>39.91987, "lon"=>32.85427}}], "overallOfficials"=>[{"name"=>"Rahime E Karakaya, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Ankara Yildirim Beyazıt University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ankara Yildirim Beyazıt University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Rahime Evra KARAKAYA", "investigatorAffiliation"=>"Ankara Yildirim Beyazıt University"}}}}
