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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mothers of children with food allergy diagnosed by a multidisciplinary team | No Intervention | Mothers of children with food allergy diagnosed by a multidisciplinary team (Group 1) already followed for at least 6 months by the Tertiary Center of Pediatric Allergology.. | |
| Mothers of children with food allergy diagnosed by a non-multidisciplinary team | Experimental | Mothers of children with food allergy diagnosed by a non-multidisciplinary team who plan to visit for the first time the Tertiary Center of Pediatric Allergology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Nutritional Counseling by a multidisciplinary team | Behavioral | Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| FAQL-PB Group 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Berni Canani, MD, PhD | Contact | 0817462680 | berni@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers. |
| 6 months |
| FAQLQ-PF Group 2 | Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQLQ-PF of Group 2 mothers. | 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. | 6 months |
| FAQL-PB Group 2 versus Group 1 | Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1. | 6 months |
| FAQLQ-PF Group 2 versus Group 1 | Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1. | 6 months |
| Z-score weight for age Group 2 | Z-score weight for age of the Group 2. | At baseline and at 6 months |
| Z-score length for age Group 2 | Z-score length for age of the Group 2. | At baseline and at 6 months |
| Z-score BMI for age Group 2 | Z-score BMI for age of the Group 2. | 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. | 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. | 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. | At baseline and at 6 months |