Metabolic SyndromeCOVID-19NCT04912934
The Relationship Between COVID-19 Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome
An observational study of Metabolic Syndrome and Emotional Eating, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Emotional Eating, COVID-19
- What is being tested?
- A survey form was applied to individuals included in the study face-to-face.
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2020to 12 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Metabolic Syndrome, Emotional Eating, COVID-19
- Being tested
- A survey form was applied to individuals included in the study face-to-face.
- Keywords
- Metabolic Syndrome, COVID-19, Eating
- Medical subject headings
- Metabolic Syndrome, Emotional Eating, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A survey form was applied to individuals included in the study face-to-face.Procedure or surgery
Also called 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.
This study was completed with a descriptive, cross-sectional and relational screening model
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: A survey form was applied to individuals included in the study face-to-face. | |
| 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. Receives: Procedure: A survey form was applied to individuals included in the study face-to-face. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronavirus anxiety scale (CAS)
Total points of ≥9 on the scale shows dysfunctional anxiety related to coronavirus.
Measured: 5 month
Emotional eating scale (EES)
High points on the scale show high levels of emotional eating behavior.
Measured: 5 month.
Secondary outcomes (11)
BMI (Body Mass Index)
kg/m^2
Measured: 5 month.
Glucose
mg/dL
Measured: 5 month.
Blood pressure
Systolic and diastolic blood pressure
Measured: 5 month.
HDL
mg/dL
Measured: 5 month.
LDL
mg/dL
Measured: 5 month.
triglycerides
mg/dL
Measured: 5 month.
HbA1c
HbA1c (%)
Measured: 5 month.
insulin
ng/ml
Measured: 5 month.
HOMA-IR
index
Measured: 5 month.
total cholesterol
mg/dL
Measured: Through study completion, an average of 5 month.
CRP
mg/dL
Measured: 5 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start20 Jun 2020
- Primary completion20 Nov 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilekkucu Kalemdar, Ordu University
- Investigators
- Dilek Küçük Alemdar, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912934
- Sponsor's protocol ID
- KAEK-228
- Acronym
- COVID-19
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32731389
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Coronavirus Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04912934
- Acronym / sponsor ID
- COVID-19 / KAEK-228
- Conditions
- Metabolic Syndrome, Emotional Eating, COVID-19
- Keywords
- Metabolic Syndrome, COVID-19, Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetS diagnosis | – | Procedure: A survey form was applied to individuals included in the study face-to-face.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. |
| non-MetS | – | Procedure: A survey form was applied to individuals included in the study face-to-face.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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A survey form was applied to individuals included in the study face-to-face.Also: 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.This study was completed with a descriptive, cross-sectional and relational screening model | Procedure or surgery | MetS diagnosis, non-MetS |
Primary outcome
Coronavirus anxiety scale (CAS)
Time frame: 5 month
Total points of ≥9 on the scale shows dysfunctional anxiety related to coronavirus.
Emotional eating scale (EES)
Time frame: 5 month.
High points on the scale show high levels of emotional eating behavior.
11 secondary outcomes
BMI (Body Mass Index)
Time frame: 5 month.
Glucose
Time frame: 5 month.
Blood pressure
Time frame: 5 month.
HDL
Time frame: 5 month.
LDL
Time frame: 5 month.
triglycerides
Time frame: 5 month.
HbA1c
Time frame: 5 month.
insulin
Time frame: 5 month.
HOMA-IR
Time frame: 5 month.
total cholesterol
Time frame: Through study completion, an average of 5 month.
CRP
Time frame: 5 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Background: PubMed 32731389Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Küçük Alemdar study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Emotional Eating, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronavirus anxiety scale (CAS) (time frame: 5 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.