Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases

Not Applicable

Completed

• Conditions: Children With Food Allergy

• Registration Number: NCT02008643
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

Detailed Description

Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

* To compare generic and specific HRQL scores in children with food allergy

* Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

Generic HRQL questionnaire (CHQ-87) will be distributed :

* after hospital consultation for patients

* in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the " Food Allergy Independent Measure " will also distributed to chidren with food allergy.

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Study Start: 2014-02
• Primary Completion: 2014-02
• Status Verified: 2016-03
• Study Completion: 2016-04
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 861

Inclusion Criteria

• Age between 8-18 year old
• IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:

Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE

• Signed informed consent of the two parents
• Signed informed consent of the child
• Health insurance recipient

Exclusion Criteria

• Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
• Partially or not controlled asthma during last year
• No signed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
comparison of12 scores of the generic health-related quality of life questionnaire CHQ-CF 87 between children with food allergy and healthy children scores.	Once at inclusion	12 scores concerning the 12 following dimensions: * physical functioning; * role functioning emotional; * role functioning behavior; * role functioning physical; * bodily pain; * general behavior; * mental health; * self-esteem; * general health; * change in health; * family activities; * family cohesion; Comparison between children with food allergy and healthy children scores.

Secondary Outcome Measures

Name	Time	Method
comparaison beetween all questionnary	once at inclusion	1. Comparison of the CHQ-CF 87 scores between children with food allergy and chidren with other chronic diseases.; 2. Comparison of the CHQ-CF 87 scores with the FAQLQ-CF (or -TF) score (global and 4 dimensions) and with the FAIM score.; 3. Comparison of the FAQLQ-CF (or-TF) (global and 4 dimensions) with clinical characteristics of the children with food allergy

Trial Locations

Locations (1)

Service de Pédiatrie; 🇫🇷 Nice, France