Anxiety, Depression and Eating Attitudes of Diabetes Mellitus Patients During COVID-19 Lockdown in Greece

January 22, 2021 updated by: Chania General Hospital "St. George"

The Effect of COVID-19 National Lockdown on People With Diabetes Mellitus Regarding Their Anxiety, Depression and Eating Attitudes, in Relation to Adjusted Work and Family Conditions

The aim of this observational, cross-sectional study is to evaluate the impact of the second national COVID-19 lockdown in Greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

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 national Lockdown was an attempt by the Governments around the world to prevent the spreading of the SARS-CoV-2. This pandemic turned out to be a major public health challenge. In Greece two national lockdown were imposed in 2020, among other measures, in order to minimize the spread of the SARS-CoV-2. The national lockdown consists of the temporary closure of the sports arenas, theaters, cafeterias, restaurants, cinemas, archaeological sites, schools, churches universities and most of the businesses . The first national lockdown in Greece was imposed from March 23th to May 4th and the second one took place from November 6th until now. Such a lockdown that forces the majority of individuals to stay at home for a prolonged period of time, except the controlled movement of the individuals for some cases, could expectedly enough have quite an impact on the daily life of people with diabetes mellitus. Changes to dietary habits, limitation of physical activity, as well as the psychological aspects like those of depression and anxiety have been detected. The aim of this study is to evaluate the impact of the second national lockdown in Greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

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.
150

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

  • Greece
    • Crete
      • Chania, Crete, Greece, 73100
        • General Hospital of Chania

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be recruited from the outpatient diabetes clinic of General Hospital of Chania and the Diabetes Center of the1st Propaedeutic Department of Internal Medicine of AHEPA General University Hospital of Thessaloniki in Greece. All participants prior to completing the survey had to give their informed consent in order to continue. Participants were free to abandon the survey at any time without any sanctions.

Description

Inclusion Criteria:

  • age ≥18 years
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • MODY Diabetes Mellitus

Exclusion Criteria:

  • age <18 years
  • gestational Diabetes

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

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.
working condition
In order to further explore the differences among working status the data will be categorized into three different groups: suspension of work, employment and unemployment.
Other: DASS questionnaire
The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress
Other: EAT-26 questionnaire
The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.
Family status
In order to xplore the differences among the family status, the data will be categorized into the married and the singles DM patients.
Other: DASS questionnaire
The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress
Other: EAT-26 questionnaire
The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.
BMI status
In order to further explore BMI scale results, we divided the data obtained from the participants into normal (18.50 - 24.99 kg/m2), overweight (25-29.99 kg/m2) and obese (≥30 kg/m2), according to the international classification of the World Health Organisation (WHO).
Other: DASS questionnaire
The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress
Other: EAT-26 questionnaire
The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.

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
DASS (Depression)
Time Frame: Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.
Minimum score 0 maximum score 42 of the depression subscale of the DASS questionnaire Higher scores mean a worse outcome
Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.
DASS (Anxiety)
Time Frame: Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.
Minimum score 0 maximum score 42 of the anxiety subscale of the DASS questionnaire Higher scores mean a worse outcome
Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

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
Eating Attitudes Test (EAT-26)
Time Frame: Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

Minimun score 0 maximum score 78 Scores greater than 20 indicate a need for further investigation by a qualified professional.

Low scores (below 20) can still be consistent with serious eating problems.
Time Frame: Brief standardised questionnaire not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

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.
Chania General Hospital "St. George"

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AHEPA University Hospital of Thessaloniki Thessaloniki, Greece

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.
December 28, 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.
January 11, 2021

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.
January 11, 2021

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).
January 6, 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.
January 6, 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.
January 7, 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.
January 25, 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.
January 22, 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.
January 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.
  • Diabetes and COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

contact via e-mail

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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