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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other Names:
  • 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.
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.
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
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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