Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease

July 24, 2022 updated by: Ayla Irem Aydin, Uludag University

Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bursa, Turkey, 16059
        • Bursa Uludağ University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-Having any cognitive or mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescents with celiac disease adherence to their diet
Time Frame: 4 month
In this study, dietary compliance of adolescents with celiac disease was examined using the Gluten-Free Diet Compliance Form.
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of the pandemic on the gluten-free diet
Time Frame: 4 month
The Factors Affecting Gluten-Free Diet Compliance form was used to determine the factors affecting adolescents' adherence to a gluten-free diet during the Covid-19 pandemic period.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayla İrem Aydın, Phd, Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Celiac Disease in Adolescents

Subscribe