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Completed

NCT Number: NCT04700254

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

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.

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Key information

Conditions

Diabetes Mellitus Anxiety Disorders Behavior Behavioral Symptoms Depression Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases SARS-CoV-2

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Chania

Chania, Crete, 73100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age <18 years
  • gestational Diabetes

Treatment and study plan

DASS questionnaire

Other

The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress

EAT-26 questionnaire

Other

The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chania General Hospital "St. George"

Other

Collaborators

  • AHEPA University Hospital

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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