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

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ClinicalTrials.gov Identifier: NCT04700254
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
AHEPA University Hospital of Thessaloniki Thessaloniki, Greece
Information provided by (Responsible Party):
Chania General Hospital "St. George"

Study Description
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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
Diabetes Mellitus SARS-CoV-2 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
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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 : December 28, 2020
Actual Primary Completion Date : January 11, 2021
Actual Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700254


Locations
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Greece
General Hospital of Chania
Chania, Crete, Greece, 73100
Sponsors and Collaborators
Chania General Hospital "St. George"
AHEPA University Hospital of Thessaloniki Thessaloniki, Greece
More Information
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Publications of Results:

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Responsible Party: Chania General Hospital "St. George"
ClinicalTrials.gov Identifier: NCT04700254    
Other Study ID Numbers: Diabetes and COVID-19
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: contact via e-mail

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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":
Diabetes Mellitus
Anxiety
Depression
Eating attitudes
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms