NCT04700254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

14 days

First QC Date

January 6, 2021

Last Update Submit

January 22, 2021

Conditions

Keywords

Diabetes MellitusAnxietyDepressionEating attitudes

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • Eating Attitudes Test (EAT-26)

    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.

Study Arms (3)

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.

Other: DASS questionnaireOther: 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.

Other: DASS questionnaireOther: 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).

Other: DASS questionnaireOther: EAT-26 questionnaire

Interventions

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

BMI statusFamily statusworking condition

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

BMI statusFamily statusworking condition

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • age \<18 years
  • gestational Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Chania

Chania, Crete, 73100, Greece

Location

Related 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 25.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes MellitusAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

December 28, 2020

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations