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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Chania General Hospital "St. George"

Collaborators

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)

December 28, 2020

Primary Completion (Actual)

January 11, 2021

Study Completion (Actual)

January 11, 2021

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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