The Quality of Life of Mothers of Children With Food Allergy

NCT ID: NCT04740632

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2023-01-10

Brief Summary

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).

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mothers of children with food allergy diagnosed by a multidisciplinary team

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..

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mothers of children with food allergy diagnosed by a non-multidisciplinary team

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.

Group Type: EXPERIMENTAL

Personalized Nutritional Counseling by a multidisciplinary team

Intervention Type: BEHAVIORAL

Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes

Interventions

Personalized Nutritional Counseling by a multidisciplinary team

Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult mother of a patient <12 years of age diagnosed with FA

Exclusion Criteria

• Mother's age <18 years
• Mother unable to understand Italian
• Mother suffering from chronic diseases
• Mother suffering from epilepsy
• Mother suffering from neoplasms
• Mother suffering from immunodeficiencies
• Mother suffering from chronic infections
• Mother suffering from autoimmune diseases
• Mother suffering from inflammatory bowel diseases
• Mother suffering from functional gastrointestinal disorders
• Mother suffering from celiac disease
• Mother suffering from genetic-metabolic diseases
• Mother suffering from tuberculosis
• Mother suffering from congenital heart disease
• Mother suffering from tuberculosis
• Mother suffering from cystic fibrosis
• Mother suffering from other chronic pulmonary diseases
• Mother suffering from major malformations
• Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract
• Mother suffering from diabetes
• Mother suffering from neuropsychiatric and neurological disorders
• Mother suffering from eosinophilic disorders of the gastrointestinal tract
• Mother not living with her child with FA
• Concomitant presence in the child with FA of chronic diseases
• Concomitant presence in the child with FA of epilepsy
• Concomitant presence in the child with FA of neoplasms
• Concomitant presence in the child with FA of immunodeficiencies
• Concomitant presence in the child with FA of chronic infections
• Concomitant presence in the child with FA of autoimmune diseases
• Concomitant presence in the child with FA of inflammatory bowel diseases
• Concomitant presence in the child with FA of functional gastrointestinal disorders
• Concomitant presence in the child with FA of celiac disease
• Concomitant presence in the child with FA of genetic-metabolic diseases
• Concomitant presence in the child with FA of tuberculosis
• Concomitant presence in the child with FA of congenital heart disease
• Concomitant presence in the child with FA of tuberculosis
• Concomitant presence in the child with FA of cystic fibrosis
• Concomitant presence in the child with FA of other chronic lung diseases
• Concomitant presence in the child with FA of major malformations
• Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract
• Concomitant presence in the child with FA of diabetes
• Concomitant presence in the child with FA of neuropsychiatric and neurological disorders
• Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract
• Concomitant presence in the child with FA of allergic diseases other than FA.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Berni Canani, MD, PhD

Role: CONTACT

berni@unina.it

0817462680

Facility Contacts

Roberto Berni Canani, MD, PhD

Role: primary

berni@unina.it

0817462680

Other Identifiers

283/20

Identifier Type: -

Identifier Source: org_study_id