The Quality of Life of Mothers of Children With Food Allergy

The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy

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 Overview

• Status: Recruiting
• Conditions: Food Allergy
• Intervention / Treatment: Behavioral: Personalized Nutritional Counseling by a multidisciplinary team

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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..
Experimental: 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.	Behavioral: Personalized Nutritional Counseling by a multidisciplinary team; Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): June 10, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 283/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No