Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04912934
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between COVID-19 Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D000098382', 'term': 'Emotional Eating'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'C099252', 'term': 'oxidized low density lipoprotein'}, {'id': 'D002784', 'term': 'Cholesterol'}, {'id': 'D014280', 'term': 'Triglycerides'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005989', 'term': 'Glycerides'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronavirus anxiety scale (CAS)', 'timeFrame': '5 month', 'description': 'Total points of ≥9 on the scale shows dysfunctional anxiety related to coronavirus.'}, {'measure': 'Emotional eating scale (EES)', 'timeFrame': '5 month.', 'description': 'High points on the scale show high levels of emotional eating behavior.'}], 'secondaryOutcomes': [{'measure': 'BMI (Body Mass Index)', 'timeFrame': '5 month.', 'description': 'kg/m\\^2'}, {'measure': 'Glucose', 'timeFrame': '5 month.', 'description': 'mg/dL'}, {'measure': 'Blood pressure', 'timeFrame': '5 month.', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'HDL', 'timeFrame': '5 month.', 'description': 'mg/dL'}, {'measure': 'LDL', 'timeFrame': '5 month.', 'description': 'mg/dL'}, {'measure': 'triglycerides', 'timeFrame': '5 month.', 'description': 'mg/dL'}, {'measure': 'HbA1c', 'timeFrame': '5 month.', 'description': 'HbA1c (%)'}, {'measure': 'insulin', 'timeFrame': '5 month.', 'description': 'ng/ml'}, {'measure': 'HOMA-IR', 'timeFrame': '5 month.', 'description': 'index'}, {'measure': 'total cholesterol', 'timeFrame': 'Through study completion, an average of 5 month.', 'description': 'mg/dL'}, {'measure': 'CRP', 'timeFrame': '5 month.', 'description': 'mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'COVID-19', 'Eating'], 'conditions': ['Metabolic Syndrome', 'Emotional Eating', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '32731389', 'type': 'BACKGROUND', 'citation': 'Zhang J, Zhang Y, Huo S, Ma Y, Ke Y, Wang P, Zhao A. Emotional Eating in Pregnant Women during the COVID-19 Pandemic and Its Association with Dietary Intake and Gestational Weight Gain. Nutrients. 2020 Jul 28;12(8):2250. doi: 10.3390/nu12082250.'}]}, 'descriptionModule': {'briefSummary': 'The aim was to determine the coronavirus anxiety levels and emotional eating status of cases with diagnosis of MetS according to diagnostic criteria published by the International Diabetic Federation (IDF) in 2005 and healthy individuals with similar BMI to MetS subjects.', 'detailedDescription': 'The aim was to determine the coronavirus anxiety levels and emotional eating status of cases with diagnosis of MetS according to diagnostic criteria published by the International Diabetic Federation (IDF) in 2005 and healthy individuals with similar BMI to MetS subjects. This study was completed with the descriptive, cross-sectional and relational screening model. The full sampling method was used in the study. The study was completed with 105 individuals with metabolic syndrome attending the diet clinic and 109 healthy individuals without MetS diagnosis also attending the diet clinic. Collection of data used anthropometric measurements and biochemical findings, blood pressure and a survey form, the Coronavirus Anxiety Scale (CAS) and Emotional Eating Scale (EES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Power analysis was performed using the G\\*Power (v3.1.9) program to determine the number of samples. According to Jacob Cohen's effect size coefficients, it was calculated that there should be at least 105 people in the groups for α=0.05 and 1-β=0.95 (95% power) levels, assuming that the evaluations between the two independent groups would have a medium effect size (d=0.5).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The MetS group for the research included individuals with metabolic syndrome diagnosis according to IDF-2005 diagnostic criteria. The non MetS group in the research included healthy individuals not using any psychiatric medications, without any chronic disorder, and with similar BMI to the individuals in the subject group.\n\nExclusion Criteria:\n\n* The research included individuals aged 18 years and older, who were pregnant or breastfeeding, with psychological disorder diagnosed by psychiatry, with diagnosis of COVID-19 and using psychiatric medications.'}, 'identificationModule': {'nctId': 'NCT04912934', 'acronym': 'COVID-19', 'briefTitle': 'The Relationship Between COVID-19 Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'The Relationship Between Coronavirus Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'KAEK-228'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MetS diagnosis', 'description': 'The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The MetS group for the research included individuals with metabolic syndrome diagnosis according to IDF-2005 diagnostic criteria.', 'interventionNames': ['Procedure: A survey form was applied to individuals included in the study face-to-face.']}, {'label': 'non-MetS', 'description': 'The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The non MetS group in the research included healthy individuals not using any psychiatric medications, without any chronic disorder, and with similar BMI to the individuals in the subject group.', 'interventionNames': ['Procedure: A survey form was applied to individuals included in the study face-to-face.']}], 'interventions': [{'name': 'A survey form was applied to individuals included in the study face-to-face.', 'type': 'PROCEDURE', 'otherNames': ['This survey form', 'Biochemical findings (glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR).', 'Blood pressure was measured and recorded.', 'The coronavirus anxiety scale (CAS) and emotional eating scale (EES) were applied.'], 'description': 'This study was completed with a descriptive, cross-sectional and relational screening model', 'armGroupLabels': ['MetS diagnosis', 'non-MetS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52000', 'city': 'Ordu', 'country': 'Turkey (Türkiye)', 'facility': 'Dilek alemdar', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}], 'overallOfficials': [{'name': 'Dilek Küçük Alemdar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ordu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dilekkucu Kalemdar', 'investigatorAffiliation': 'Ordu University'}}}}