- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04912934
The Relationship Between COVID-19 Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome (COVID-19)
June 2, 2021 updated by: Dilekkucu Kalemdar, T.C. ORDU ÜNİVERSİTESİ
The Relationship Between Coronavirus Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
214
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ordu, Turkey, 52000
- Dilek alemdar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MetS diagnosis
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.
|
This study was completed with a descriptive, cross-sectional and relational screening model
Other Names:
|
non-MetS
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.
|
This study was completed with a descriptive, cross-sectional and relational screening model
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronavirus anxiety scale (CAS)
Time Frame: 5 month
|
Total points of ≥9 on the scale shows dysfunctional anxiety related to coronavirus.
|
5 month
|
Emotional eating scale (EES)
Time Frame: 5 month.
|
High points on the scale show high levels of emotional eating behavior.
|
5 month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI (Body Mass Index)
Time Frame: 5 month.
|
kg/m^2
|
5 month.
|
Glucose
Time Frame: 5 month.
|
mg/dL
|
5 month.
|
Blood pressure
Time Frame: 5 month.
|
Systolic and diastolic blood pressure
|
5 month.
|
HDL
Time Frame: 5 month.
|
mg/dL
|
5 month.
|
LDL
Time Frame: 5 month.
|
mg/dL
|
5 month.
|
triglycerides
Time Frame: 5 month.
|
mg/dL
|
5 month.
|
HbA1c
Time Frame: 5 month.
|
HbA1c (%)
|
5 month.
|
insulin
Time Frame: 5 month.
|
ng/ml
|
5 month.
|
HOMA-IR
Time Frame: 5 month.
|
index
|
5 month.
|
total cholesterol
Time Frame: Through study completion, an average of 5 month.
|
mg/dL
|
Through study completion, an average of 5 month.
|
CRP
Time Frame: 5 month.
|
mg/dL
|
5 month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: DİLEK KÜÇÜK ALEMDAR, T.C. ORDU ÜNİVERSİTESİ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2020
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
December 12, 2020
Study Registration Dates
First Submitted
May 30, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 3, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- COVID-19
- Syndrome
- Metabolic Syndrome
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
Other Study ID Numbers
- KAEK-228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on A survey form was applied to individuals included in the study face-to-face.
-
Necmettin Erbakan UniversityActive, not recruitingPeriodontitis | MEDİTERRANEAN DİETTurkey
-
Okan UniversityCompleted
-
YMD Eye and FaceCompletedFacial WrinklesUnited States
-
Qatar UniversityHamad Medical CorporationCompleted
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedSkin Regeneration After Dermatological Facial Procedure With Fractional CO2 LaserBrazil
-
Cambridge University Hospitals NHS Foundation TrustObstetric Anaesthetists' AssociationRecruitingAnesthesiaUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterCompletedRectal CancerUnited States