Clinical trial NCT04740632: The Quality of Life of Mothers of Children With Food Allergy
Official title: The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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.

Primary outcomes:
measure: FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
timeFrame: baseline
measure: FAQL-PB
timeFrame: baseline
measure: FAQLQ-PF
timeFrame: baseline
Secondary outcomes:
measure: FASE-P Group 2
timeFrame: 6 months
measure: FAQL-PB Group 2
timeFrame: 6 months
measure: FAQLQ-PF Group 2
timeFrame: 6 months
measure: FASE-P at 6 months Group 2 versus Group 1
timeFrame: 6 months
measure: FAQL-PB Group 2 versus Group 1
timeFrame: 6 months
measure: FAQLQ-PF Group 2 versus Group 1
timeFrame: 6 months
measure: Z-score weight for age Group 2
timeFrame: At baseline and at 6 months
measure: Z-score length for age Group 2
timeFrame: At baseline and at 6 months
measure: Z-score BMI for age Group 2
timeFrame: At baseline and at 6 months
measure: Z-score weight for age Group 2 versus Group 1
timeFrame: At baseline and at 6 months
measure: Z-score length for age Group 2 versus Group 1
timeFrame: At baseline and at 6 months
measure: Z-score BMI for age Group 2 versus Group 1
timeFrame: At baseline and at 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References: