Clinical Trials Directory

Trials / Unknown

UnknownNCT04740632

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Federico II University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALPersonalized Nutritional Counseling by a multidisciplinary teamActive diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes

Timeline

Start date
2022-01-10
Primary completion
2022-06-10
Completion
2023-01-10
First posted
2021-02-05
Last updated
2022-09-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04740632. Inclusion in this directory is not an endorsement.