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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"

Tracking Information
First Submitted Date January 6, 2021
First Posted Date January 7, 2021
Last Update Posted Date January 25, 2021
Actual Study Start Date December 28, 2020
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2021)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: January 6, 2021)
  • Diabetes mellitus working condition and depression scale [ Time Frame: Time Frame: Brief standardised questionnaires not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study. ]
    People with Dabetes Mellitus who have been working at their workplace compared to those who were suspended or have been teleworking during the Lockdown period, will have a statistically lower score on the depression scale of DASS.
  • Diabetes mellitus working condition and anxiety scale [ Time Frame: Time Frame: Brief standardised questionnaires not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study. ]
    People with Dabetes Mellitus who have been working at their workplace compared to those who were suspended or have been teleworking during the Lockdown period, will have a statistically lower score on the anxiety scale of DASS.
  • Diabetes mellitus working condition and eating attitudes [ Time Frame: Time Frame: Brief standardised questionnaires not exceeding 8 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study. ]
    People with DM who have been working at their workplace compared to those who were suspended or have been teleworking during the Lockdown period, will have a statistically lower score on the bulimia-food preoccupation and oral control subscale of EAT-26.
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2021)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anxiety, Depression and Eating Attitudes of Diabetes Mellitus Patients During COVID-19 Lockdown in Greece
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
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Diabetes Mellitus
  • SARS-CoV-2
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Other: DASS questionnaire
    • Other: EAT-26 questionnaire
  • 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.
    Interventions:
    • Other: DASS questionnaire
    • Other: EAT-26 questionnaire
  • 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).
    Interventions:
    • Other: DASS questionnaire
    • Other: EAT-26 questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2021)
150
Original Estimated Enrollment
 (submitted: January 6, 2021)
102
Actual Study Completion Date January 11, 2021
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age <18 years
  • gestational Diabetes
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT04700254
Other Study ID Numbers Diabetes and COVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: contact via e-mail
Responsible Party Chania General Hospital "St. George"
Study Sponsor Chania General Hospital "St. George"
Collaborators AHEPA University Hospital of Thessaloniki Thessaloniki, Greece
Investigators Not Provided
PRS Account Chania General Hospital "St. George"
Verification Date January 2021