NCT05474976

Brief Summary

Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors. The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 20, 2022

Last Update Submit

July 24, 2022

Conditions

Keywords

AdolescenceCeliac Diseasegluten free diet

Outcome Measures

Primary Outcomes (1)

  • Adolescents with celiac disease adherence to their diet

    In this study, dietary compliance of adolescents with celiac disease was examined using the Gluten-Free Diet Compliance Form.

    4 month

Secondary Outcomes (1)

  • The effects of the pandemic on the gluten-free diet

    4 month

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The population of this cross-sectional study of adolescents diagnosed with celiac disease in the 10-19 age group, registered to an association. Study sample of 85 participants who met the inclusion criteria and agreed to participate in the study.

You may qualify if:

  • Being in the 10-19 age group,
  • Being diagnosed with celiac disease according to the revised ESPGHAN criteria,
  • Following a gluten-free diet for at least 6 months before the COVID-19 lockdown,
  • Consenting to participate in the study by the adolescents and their parents.

You may not qualify if:

  • Having any cognitive or mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ University

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ayla İrem Aydın, Phd

    Uludag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD, RN

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 26, 2022

Study Start

January 1, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

It can be shared if there is a request for sharing.

Locations