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The Quality of Life of Mothers of Children With Food Allergy

Primary Purpose

Food Allergy

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Personalized Nutritional Counseling by a multidisciplinary team
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Food Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Traslational Medical Science - University of Naples Federico IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Mothers of children with food allergy diagnosed by a multidisciplinary team

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

Arm Description

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 who plan to visit for the first time the Tertiary Center of Pediatric Allergology.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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
FAQL-PB Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers.
FAQLQ-PF Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQLQ-PF of Group 2 mothers.
FASE-P at 6 months Group 2 versus Group 1
Compare after 6 months (T6) the FASE-P of Group 2 versus Group 1.
FAQL-PB Group 2 versus Group 1
Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1.
FAQLQ-PF Group 2 versus Group 1
Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1.
Z-score weight for age Group 2
Z-score weight for age of the Group 2.
Z-score length for age Group 2
Z-score length for age of the Group 2.
Z-score BMI for age Group 2
Z-score BMI for age of the Group 2.
Z-score weight for age Group 2 versus Group 1
Z-score weight for age of comparing the Group 1 and Group 2.
Z-score length for age Group 2 versus Group 1
Z-score lenght for age of comparing the Group 1 and Group 2.
Z-score BMI for age Group 2 versus Group 1
Z-score BMI for age of comparing the Group 1 and Group 2.

Full Information

First Posted
February 2, 2021
Last Updated
September 27, 2022
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT04740632
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
January 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mothers of children with food allergy diagnosed by a multidisciplinary team
Arm Type
No Intervention
Arm Description
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..
Arm Title
Mothers of children with food allergy diagnosed by a non-multidisciplinary team
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Nutritional Counseling by a multidisciplinary team
Intervention Description
Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes
Primary Outcome Measure Information:
Title
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
Description
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).
Time Frame
baseline
Title
FAQL-PB
Description
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).
Time Frame
baseline
Title
FAQLQ-PF
Description
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).
Time Frame
baseline
Secondary Outcome Measure Information:
Title
FASE-P Group 2
Description
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
Time Frame
6 months
Title
FAQL-PB Group 2
Description
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers.
Time Frame
6 months
Title
FAQLQ-PF Group 2
Description
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQLQ-PF of Group 2 mothers.
Time Frame
6 months
Title
FASE-P at 6 months Group 2 versus Group 1
Description
Compare after 6 months (T6) the FASE-P of Group 2 versus Group 1.
Time Frame
6 months
Title
FAQL-PB Group 2 versus Group 1
Description
Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1.
Time Frame
6 months
Title
FAQLQ-PF Group 2 versus Group 1
Description
Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1.
Time Frame
6 months
Title
Z-score weight for age Group 2
Description
Z-score weight for age of the Group 2.
Time Frame
At baseline and at 6 months
Title
Z-score length for age Group 2
Description
Z-score length for age of the Group 2.
Time Frame
At baseline and at 6 months
Title
Z-score BMI for age Group 2
Description
Z-score BMI for age of the Group 2.
Time Frame
At baseline and at 6 months
Title
Z-score weight for age Group 2 versus Group 1
Description
Z-score weight for age of comparing the Group 1 and Group 2.
Time Frame
At baseline and at 6 months
Title
Z-score length for age Group 2 versus Group 1
Description
Z-score lenght for age of comparing the Group 1 and Group 2.
Time Frame
At baseline and at 6 months
Title
Z-score BMI for age Group 2 versus Group 1
Description
Z-score BMI for age of comparing the Group 1 and Group 2.
Time Frame
At baseline and at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Berni Canani, MD, PhD
Phone
0817462680
Email
berni@unina.it
Facility Information:
Facility Name
Department of Traslational Medical Science - University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD, PhD
Phone
0817462680
Email
berni@unina.it

12. IPD Sharing Statement

Plan to Share IPD
No

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The Quality of Life of Mothers of Children With Food Allergy

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