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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700254
• Other study ID #: Diabetes and COVID-19
• Status: Completed
• Start date: December 28, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: January 2021
• Source: Chania General Hospital "St. George"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• age =18 years

• Type 1 Diabetes Mellitus

• Type 2 Diabetes Mellitus

• MODY Diabetes Mellitus

Exclusion Criteria:

• age <18 years

• gestational Diabetes

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Greece	General Hospital of Chania	Chania	Crete

Sponsors (2)

Lead Sponsor	Collaborator
Chania General Hospital "St. George"	AHEPA University Hospital of Thessaloniki Thessaloniki, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Aragona M, Rodia C, Bertolotto A, Campi F, Coppelli A, Giannarelli R, Bianchi C, Dardano A, Del Prato S. Type 1 diabetes and COVID-19: The "lockdown effect". Diabetes Res Clin Pract. 2020 Dec;170:108468. doi: 10.1016/j.diabres.2020.108468. Epub 2020 Sep 2 — View Citation

Pellegrini M, Ponzo V, Rosato R, Scumaci E, Goitre I, Benso A, Belcastro S, Crespi C, De Michieli F, Ghigo E, Broglio F, Bo S. Changes in Weight and Nutritional Habits in Adults with Obesity during the "Lockdown" Period Caused by the COVID-19 Virus Emerge — View Citation

Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartín A, Sampedro-Nuñez MA, Dávalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrient — View Citation

Sakelliadis EI, Katsos KD, Zouzia EI, Spiliopoulou CA, Tsiodras S. Impact of Covid-19 lockdown on characteristics of autopsy cases in Greece. Comparison between 2019 and 2020. Forensic Sci Int. 2020 Aug;313:110365. doi: 10.1016/j.forsciint.2020.110365. Ep — View Citation

Sidor A, Rzymski P. Dietary Choices and Habits during COVID-19 Lockdown: Experience from Poland. Nutrients. 2020 Jun 3;12(6). pii: E1657. doi: 10.3390/nu12061657. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASS (Depression)	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.
Primary	DASS (Anxiety)	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	Eating Attitudes Test (EAT-26)	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.