Food AllergyEVAALIMNCT06112873
Quality of Life in Food Allergy: Validation of Three Mini-questionnaires
An observational study of Food Allergy, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The evaluation of the quality of life (QOL) in food allergy (AA) is difficult due to the lack of a currently validated questionnaire. There are only a few tools available to assess the impact of nutritional care on the QOL of the allergic patient . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergy
- What is being tested?
- Quality of Life Questionnaire
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2023to 5 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (or patients parents) cared for food allergy at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon including: * 200 parents of allergic children * 200 allergic children aged 8 to 17 years * 200 adults with food allergy
Who may be able to join
- Patients with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.
Who cannot join
- All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.
Trial locations and contacts
No sites are listed yet.
Jean-Marc RAME, MD contact
About this study
Official title: Development and Validation of Three Mini-questionnaires to Assess the Quality of Life in Food Allergic Patients
The evaluation of the quality of life (QOL) in food allergy (AA) is difficult due to the lack of a currently validated questionnaire. There are only a few tools available to assess the impact of nutritional care on the QOL of the allergic patient . Available questionnaires are poorly adapted to studies dealing with large cohorts where functionality and ease of use are determining factors. The aim of this work will be to develop and validate QOL questionnaires for AA, short and easy to use, also integrating the theme of collective catering in order to assess the evolution of QOL in patients with food allergy.
The target population of the questionnaires will be:
Read more
- the parents of allergic children 0 to 17 years (15 questions) ii) allergic children aged 8 to 17 years (13 questions) iii) Adults over 18 (14 questions)
After receiving an information note, eligible patients or their parents will complete the questionnaires. A total of 200 patients will be recruited for each questionnaire.
A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.
Read the detailed description
The Réseau d'Allergologie de Franche-Comté (RAFT, University Hospital of Besançon), with the participation of the Allergodiet [1] working group of the French Society of Allergy (SFA), developed this work and contribute to the selection of relevant questions for each age range.
The selected items are divided into three areas: i) social and food limitations; ii) food anxiety; and iii) the risks of accidental ingestion. A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.
Study Procedures :
After receiving an information note, eligible patients and/or their parents will complete the questionnaires.
Outcome measures:
Patient-Reported Outcomes via specific questionnaires
Participant numbers:
200 patients will be recruited for each questionnaire
Participants and recruitment:
Inclusion criteria :
Patient or parent of a patient with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.
Exclusion criteria :
All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.
Resources :
This multicenter study will be conducted at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon.
Data management:
Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder
Oversight :
- Data will be entered from a professional computer station; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) if it is a paper document, it will be stored in a secure location known only to professionals involved in the research ; iv) If it is a computerized document, it will be kept on the center's information server with access control by password.
References:
1- Doc, A., Capelli, E., Le Pabic, F., Pouessel, G., Deschildre, A., Morisset, M., \& Rame, J. M. (2020). Allergodiet: un groupe de travail de diététiciens nutritionnistes en allergologie. Revue Française d'Allergologie, 60(3), 143-149.
- Conditions
- Food Allergy
- Being tested
- Quality of Life Questionnaire
- Keywords
- Food Allergy, Quality of Life, Children, Adult, Self-reported questionnaire
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnaireOther
Patient (or Parent)-Reported Outcomes via specific questionnaires
| Study group | Role | What they receive |
|---|---|---|
| The parents of allergic children 0 to 17 years | The parents of 200 eligible patients will complete the parent questionnaire comprising 15 questions Receives: Other: Quality of Life Questionnaire | |
| Allergic children aged 8 to 17 years | A total of 200 eligible patients aged 8 to 17 years will complete the children's self-reported questionnaire comprising 13 questions. Receives: Other: Quality of Life Questionnaire | |
| Adults over 18 | A total of 200 adult patients will complete the adult self-reported questionnaire comprising 14 questions. Receives: Other: Quality of Life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability of Questionnaires
Measured: 6 months
Comparability with EUROPREVALL reference questionnaires
Measured: 3 months
Secondary outcomes (1)
Discriminative capacity of questionnaires
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start5 Nov 2023 (estimated)
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112873
- Sponsor's protocol ID
- 2023/818
- Acronym
- EVAALIM
- Status last verified
- Jun 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Three Mini-questionnaires to Assess the Quality of Life in Food Allergic Patients
- ClinicalTrials.gov ID
- NCT06112873
- Acronym / sponsor ID
- EVAALIM / 2023/818
- Conditions
- Food Allergy
- Keywords
- Food Allergy, Quality of Life, Children, Adult, Self-reported questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University Hospital, Angers, University Hospital, Toulouse, Hospices Civils de Lyon
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Nov 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation of the quality of life (QOL) in food allergy (AA) is difficult due to the lack of a currently validated questionnaire. There are only a few tools available to assess the impact of nutritional care on the QOL of the allergic patient . Available questionnaires are poorly adapted to studies dealing with large cohorts where functionality and ease of use are determining factors. The aim of this work will be to develop and validate QOL questionnaires for AA, short and easy to use, also integrating the theme of collective catering in order to assess the evolution of QOL in patients with food allergy.
The target population of the questionnaires will be:
- the parents of allergic children 0 to 17 years (15 questions) ii) allergic children aged 8 to 17 years (13 questions) iii) Adults over 18 (14 questions)
After receiving an information note, eligible patients or their parents will complete the questionnaires. A total of 200 patients will be recruited for each questionnaire.
A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.
Detailed description
The Réseau d'Allergologie de Franche-Comté (RAFT, University Hospital of Besançon), with the participation of the Allergodiet [1] working group of the French Society of Allergy (SFA), developed this work and contribute to the selection of relevant questions for each age range.
The selected items are divided into three areas: i) social and food limitations; ii) food anxiety; and iii) the risks of accidental ingestion. A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.
Study Procedures :
After receiving an information note, eligible patients and/or their parents will complete the questionnaires.
Outcome measures:
Patient-Reported Outcomes via specific questionnaires
Participant numbers:
200 patients will be recruited for each questionnaire
Participants and recruitment:
Inclusion criteria :
Patient or parent of a patient with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.
Exclusion criteria :
All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.
Resources :
This multicenter study will be conducted at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon.
Data management:
Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder
Oversight :
- Data will be entered from a professional computer station; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) if it is a paper document, it will be stored in a secure location known only to professionals involved in the research ; iv) If it is a computerized document, it will be kept on the center's information server with access control by password.
References:
1- Doc, A., Capelli, E., Le Pabic, F., Pouessel, G., Deschildre, A., Morisset, M., \& Rame, J. M. (2020). Allergodiet: un groupe de travail de diététiciens nutritionnistes en allergologie. Revue Française d'Allergologie, 60(3), 143-149.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The parents of allergic children 0 to 17 years | – | Other: Quality of Life QuestionnaireThe parents of 200 eligible patients will complete the parent questionnaire comprising 15 questions |
| Allergic children aged 8 to 17 years | – | Other: Quality of Life QuestionnaireA total of 200 eligible patients aged 8 to 17 years will complete the children's self-reported questionnaire comprising 13 questions. |
| Adults over 18 | – | Other: Quality of Life QuestionnaireA total of 200 adult patients will complete the adult self-reported questionnaire comprising 14 questions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (or patients parents) cared for food allergy at CHU de Besançon, CHU de Toulouse, CHU Angers and CHU de Lyon including: * 200 parents of allergic children * 200 allergic children aged 8 to 17 years * 200 adults with food allergy
Key inclusion criteria (1 listed)
- Patients with an IgE-mediated allergy to any food, or a non-IgE-mediated allergy to cow's milk in infants.
Key exclusion criteria (1 listed)
- All patients who do not fit the inclusion criteria mentioned above, lack of consent, mental or visual disturbances, not understanding the questionnaire language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life QuestionnairePatient (or Parent)-Reported Outcomes via specific questionnaires | Other | Adults over 18, Allergic children aged 8 to 17 years, The parents of allergic children 0 to 17 years |
Primary outcome
Validity and Reliability of Questionnaires
Time frame: 6 months
Comparability with EUROPREVALL reference questionnaires
Time frame: 3 months
1 secondary outcome
Discriminative capacity of questionnaires
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc RAME, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youcef SHAHALI, PhD (+33 3 81 21 84 39, yshahali@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability of Questionnaires (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.