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

Sponsor
Chania General Hospital "St. George" (Other)
Overall Status
Completed
CT.gov ID
NCT04700254
Collaborator
AHEPA University Hospital of Thessaloniki Thessaloniki, Greece (Other)
150
1
14
326.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: DASS questionnaire
  • Other: EAT-26 questionnaire

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 Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
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
Actual Study Start Date :
Dec 28, 2020
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
Jan 11, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. DASS (Depression) [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

  2. DASS (Anxiety) [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

Secondary Outcome Measures

  1. Eating Attitudes Test (EAT-26) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • age ≥18 years

  • Type 1 Diabetes Mellitus

  • Type 2 Diabetes Mellitus

  • MODY Diabetes Mellitus

Exclusion Criteria:
  • age <18 years

  • gestational Diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Chania Chania Crete Greece 73100

Sponsors and Collaborators

  • Chania General Hospital "St. George"
  • AHEPA University Hospital of Thessaloniki Thessaloniki, Greece

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chania General Hospital "St. George"
ClinicalTrials.gov Identifier:
NCT04700254
Other Study ID Numbers:
  • Diabetes and COVID-19
First Posted:
Jan 7, 2021
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chania General Hospital "St. George"
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2021