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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04912934
Other study ID # KAEK-228
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2020
Est. completion date December 12, 2020

Study information

Verified date June 2021
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date December 12, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
A survey form was applied to individuals included in the study face-to-face.
This study was completed with a descriptive, cross-sectional and relational screening model

Locations

Country Name City State
Turkey Dilek alemdar Ordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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). pii: E2250. doi: 10.3390/nu12082250. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Coronavirus anxiety scale (CAS) Total points of =9 on the scale shows dysfunctional anxiety related to coronavirus. 5 month
Primary Emotional eating scale (EES) High points on the scale show high levels of emotional eating behavior. 5 month.
Secondary BMI (Body Mass Index) kg/m^2 5 month.
Secondary Glucose mg/dL 5 month.
Secondary Blood pressure Systolic and diastolic blood pressure 5 month.
Secondary HDL mg/dL 5 month.
Secondary LDL mg/dL 5 month.
Secondary triglycerides mg/dL 5 month.
Secondary HbA1c HbA1c (%) 5 month.
Secondary insulin ng/ml 5 month.
Secondary HOMA-IR index 5 month.
Secondary total cholesterol mg/dL Through study completion, an average of 5 month.
Secondary CRP mg/dL 5 month.
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