Diabetes MellitusNCT04700254
Anxiety, Depression and Eating Attitudes of Diabetes Mellitus Patients During COVID-19 Lockdown in Greece
An observational study of Diabetes Mellitus and SARS-CoV-2, run by Chania General Hospital "St. George" at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, SARS-CoV-2
- What is being tested?
- DASS questionnaire and EAT-26 questionnaire
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 28 Dec 2020to 11 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age ≥18 years
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
- MODY Diabetes Mellitus
Who cannot join
- age <18 years
- gestational Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, SARS-CoV-2
- Being tested
- DASS questionnaire, EAT-26 questionnaire
- Keywords
- Diabetes Mellitus, Anxiety, Depression, Eating attitudes
- Medical subject headings
- Diabetes Mellitus, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASS questionnaireOther
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 questionnaireOther
The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Other: DASS questionnaire; Other: EAT-26 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASS (Depression)
Minimum score 0 maximum score 42 of the depression subscale of the DASS questionnaire Higher scores mean a worse outcome
Measured: 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.
DASS (Anxiety)
Minimum score 0 maximum score 42 of the anxiety subscale of the DASS questionnaire Higher scores mean a worse outcome
Measured: 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 (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start28 Dec 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chania General Hospital "St. George"
- Sponsor type
- University, hospital or other
- Collaborators
- AHEPA University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700254
- Sponsor's protocol ID
- Diabetes and COVID-19
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: contact via e-mail
Publications
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.
PubMed 32987040Sakelliadis 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.
PubMed 32563134Sidor 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.
PubMed 32503173Ruiz-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.
PubMed 32759636Pellegrini 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.
PubMed 32645970
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04700254
- Acronym / sponsor ID
- Diabetes and COVID-19
- Conditions
- Diabetes Mellitus, SARS-CoV-2
- Keywords
- Diabetes Mellitus, Anxiety, Depression, Eating attitudes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chania General Hospital "St. George"University, hospital or other
- Collaborators
- AHEPA University Hospital
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| working condition | – | Other: DASS questionnaire, Other: EAT-26 questionnaireIn order to further explore the differences among working status the data will be categorized into three different groups: suspension of work, employment and unemployment. |
| Family status | – | Other: DASS questionnaire, Other: EAT-26 questionnaireIn order to xplore the differences among the family status, the data will be categorized into the married and the singles DM patients. |
| BMI status | – | Other: DASS questionnaire, Other: EAT-26 questionnaireIn 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age ≥18 years
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
- MODY Diabetes Mellitus
Key exclusion criteria (2 listed)
- age <18 years
- gestational Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASS questionnaireThe DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress | Other | BMI status, Family status, working condition |
| EAT-26 questionnaireThe Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders. | Other | BMI status, Family status, working condition |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Results publication: PubMed 32987040Aragona 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.
- Results publication: PubMed 32563134Sakelliadis 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.
- Results publication: PubMed 32503173Sidor 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.
- Results publication: PubMed 32759636Ruiz-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.
- Results publication: PubMed 32645970Pellegrini 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.
- Individual participant dataSharing planned: Undecided. contact via e-mail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and SARS-CoV-2, run by Chania General Hospital "St. George" at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700254, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.