The Quality of Life of Mothers of Children With Food Allergy

NCT04740632 | Unknown

• 1 other identifier: 283/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (12)

• FASE-P Group 2

  6 months

• FAQL-PB Group 2

  6 months

• FAQLQ-PF Group 2

  6 months

• FASE-P at 6 months Group 2 versus Group 1

  6 months

• FAQL-PB Group 2 versus Group 1

  6 months

Study Arms (2)

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.

Behavioral: Personalized Nutritional Counseling by a multidisciplinary team

Interventions

Personalized Nutritional Counseling by a multidisciplinary team BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Roberto Berni Canani, MD, PhD

CONTACT

0817462680; berni@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: January 10, 2022
• Primary Completion: June 10, 2022
• Study Completion: January 10, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)