NCT04912934

Brief Summary

The aim was to determine the coronavirus anxiety levels and emotional eating status of cases with diagnosis of MetS according to diagnostic criteria published by the International Diabetic Federation (IDF) in 2005 and healthy individuals with similar BMI to MetS subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

June 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

May 30, 2021

Last Update Submit

June 2, 2021

Conditions

Keywords

Metabolic SyndromeCOVID-19Eating

Outcome Measures

Primary Outcomes (2)

  • Coronavirus anxiety scale (CAS)

    Total points of ≥9 on the scale shows dysfunctional anxiety related to coronavirus.

    5 month

  • Emotional eating scale (EES)

    High points on the scale show high levels of emotional eating behavior.

    5 month.

Secondary Outcomes (11)

  • BMI (Body Mass Index)

    5 month.

  • Glucose

    5 month.

  • Blood pressure

    5 month.

  • HDL

    5 month.

  • LDL

    5 month.

  • +6 more secondary outcomes

Study Arms (2)

MetS diagnosis

The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The MetS group for the research included individuals with metabolic syndrome diagnosis according to IDF-2005 diagnostic criteria.

Procedure: A survey form was applied to individuals included in the study face-to-face.

non-MetS

The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The non MetS group in the research included healthy individuals not using any psychiatric medications, without any chronic disorder, and with similar BMI to the individuals in the subject group.

Procedure: A survey form was applied to individuals included in the study face-to-face.

Interventions

This study was completed with a descriptive, cross-sectional and relational screening model

Also known as: This survey form, Biochemical findings (glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR)., Blood pressure was measured and recorded., The coronavirus anxiety scale (CAS) and emotional eating scale (EES) were applied.
MetS diagnosisnon-MetS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Power analysis was performed using the G\*Power (v3.1.9) program to determine the number of samples. According to Jacob Cohen's effect size coefficients, it was calculated that there should be at least 105 people in the groups for α=0.05 and 1-β=0.95 (95% power) levels, assuming that the evaluations between the two independent groups would have a medium effect size (d=0.5).

You may qualify if:

  • The research included individuals aged 18 years and older, who were not pregnant or breastfeeding, without any psychological disorder diagnosed by psychiatry, without diagnosis of COVID-19 and not using any psychiatric medications. The MetS group for the research included individuals with metabolic syndrome diagnosis according to IDF-2005 diagnostic criteria. The non MetS group in the research included healthy individuals not using any psychiatric medications, without any chronic disorder, and with similar BMI to the individuals in the subject group.

You may not qualify if:

  • The research included individuals aged 18 years and older, who were pregnant or breastfeeding, with psychological disorder diagnosed by psychiatry, with diagnosis of COVID-19 and using psychiatric medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

Location

Related Publications (1)

  • Zhang J, Zhang Y, Huo S, Ma Y, Ke Y, Wang P, Zhao A. Emotional Eating in Pregnant Women during the COVID-19 Pandemic and Its Association with Dietary Intake and Gestational Weight Gain. Nutrients. 2020 Jul 28;12(8):2250. doi: 10.3390/nu12082250.

    PMID: 32731389BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR

MeSH Terms

Conditions

Metabolic SyndromeEmotional EatingCOVID-19

Interventions

Glucoseoxidized low density lipoproteinCholesterolTriglyceridesInsulin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFeeding BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipidsGlyceridesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dilek Küçük Alemdar

    Ordu University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 3, 2021

Study Start

June 20, 2020

Primary Completion

November 20, 2020

Study Completion

December 12, 2020

Last Updated

June 3, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations