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

Sponsor
Uludag University (Other)
Overall Status
Completed
CT.gov ID
NCT05474976
Collaborator
(none)
85
Enrollment
1
Location
3.9
Actual Duration (Months)
21.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    85 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Apr 30, 2022
    Actual Study Completion Date :
    Apr 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Adolescents with celiac disease adherence to their diet [4 month]

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

    Secondary Outcome Measures

    1. The effects of the pandemic on the gluten-free diet [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa Uludağ University Bursa Turkey 16059

    Sponsors and Collaborators

    • Uludag University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayla Irem Aydin, Principal Investigator, PhD, RN, Uludag University
    ClinicalTrials.gov Identifier:
    NCT05474976
    Other Study ID Numbers:
    • 517517518
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayla Irem Aydin, Principal Investigator, PhD, RN, Uludag University
    Adolescence
    Celiac Disease
    gluten free diet
    Additional relevant MeSH terms:
    COVID-19
    Celiac Disease

    Study Results

    No Results Posted as of Jul 26, 2022