Clinical trial NCT04700254: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
SARS-CoV-2
Keywords: Diabetes Mellitus
Anxiety
Depression
Eating attitudes
Lead sponsor: Chania General Hospital "St. George"
Sponsor class: OTHER
Collaborators: name: AHEPA University Hospital
First posted: 2021-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: DASS (Depression)
timeFrame: 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.
measure: DASS (Anxiety)
timeFrame: 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 outcomes:
measure: Eating Attitudes Test (EAT-26)
timeFrame: 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.
Other outcomes:
Locations:
city: Chania
country: Greece
facility: General Hospital of Chania
state: Crete
Study officials:
References:
citation: 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 25.
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. Epub 2020 Jun 12.
citation: Sidor A, Rzymski P. Dietary Choices and Habits during COVID-19 Lockdown: Experience from Poland. Nutrients. 2020 Jun 3;12(6):1657. doi: 10.3390/nu12061657.
citation: Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos 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. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.
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 Emergency. Nutrients. 2020 Jul 7;12(7):2016. doi: 10.3390/nu12072016.