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NCT Number: NCT07142148

Validation of the CDAT in the Polish Paediatric Population

The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants).

The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity.

In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated.

Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of coeliac disease (CD) according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
  • age from 2 to 18 years of age,
  • consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.

Exclusion criteria

  • whose legal guardians did not consent to participate in the study,
  • who did not consent to participate in the study (applies to patients ≥ 16 years of age).

Treatment and study plan

CDAT - phase 1

Diagnostic Test

The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants). The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity.

CDAT - phase 2

Other

In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated.

Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.

Primary outcomes

  1. Validation of Celiac Dietary Adherence Test (CDAT) in the Polish paediatric population.

    Time frame: September 2025 - June 2027

    The Celiac Dietary Adherence Test (CDAT) questionnaire will be validated in the Polish paediatric population.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Validation of the Celiac Dietary Adherence Test in the Polish Paediatric Population

Acronym: CD-PL-CDAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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