Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with FA, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, Italy
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
To explore potential differences at baseline (T0) in the quality of life, provided by the FASE-P questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Time frame: baseline
FAQL-PB
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQL-PB questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Time frame: baseline
FAQLQ-PF
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQLQ-PF questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Time frame: baseline
FASE-P Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FASE-P of Group 2 mothers; and minimun and maximum of the three specific questionnaires for food allergies administered to the patient's mother
Time frame: 6 months
FAQL-PB Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers.
Time frame: 6 months
FAQLQ-PF Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQLQ-PF of Group 2 mothers.
Time frame: 6 months
FASE-P at 6 months Group 2 versus Group 1
Compare after 6 months (T6) the FASE-P of Group 2 versus Group 1.
Time frame: 6 months
FAQL-PB Group 2 versus Group 1
Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1.
Time frame: 6 months
FAQLQ-PF Group 2 versus Group 1
Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1.
Time frame: 6 months
Z-score weight for age Group 2
Z-score weight for age of the Group 2.
Time frame: At baseline and at 6 months
Z-score length for age Group 2
Z-score length for age of the Group 2.
Time frame: At baseline and at 6 months
Z-score BMI for age Group 2
Z-score BMI for age of the Group 2.
Time frame: At baseline and at 6 months
Z-score weight for age Group 2 versus Group 1
Z-score weight for age of comparing the Group 1 and Group 2.
Time frame: At baseline and at 6 months
Z-score length for age Group 2 versus Group 1
Z-score lenght for age of comparing the Group 1 and Group 2.
Time frame: At baseline and at 6 months
Z-score BMI for age Group 2 versus Group 1
Z-score BMI for age of comparing the Group 1 and Group 2.
Time frame: At baseline and at 6 months
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