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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Personalized Nutritional Counseling by a multidisciplinary team | Active 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.