The Quality of Life of Mothers of Children With Food Allergy

August 31, 2026 updated by: Roberto Berni Canani, MD, PhD, Federico II University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
Time Frame: baseline
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
Time Frame: baseline
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
Time Frame: baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FASE-P Group 2
Time Frame: 6 months
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
Time Frame: 6 months
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers.
6 months
FAQLQ-PF Group 2
Time Frame: 6 months
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
Time Frame: 6 months
Compare after 6 months (T6) the FASE-P of Group 2 versus Group 1.
6 months
FAQL-PB Group 2 versus Group 1
Time Frame: 6 months
Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1.
6 months
FAQLQ-PF Group 2 versus Group 1
Time Frame: 6 months
Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1.
6 months
Z-score weight for age Group 2
Time Frame: At baseline and at 6 months
Z-score weight for age of the Group 2.
At baseline and at 6 months
Z-score length for age Group 2
Time Frame: At baseline and at 6 months
Z-score length for age of the Group 2.
At baseline and at 6 months
Z-score BMI for age Group 2
Time Frame: At baseline and at 6 months
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
Time Frame: At baseline and at 6 months
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
Time Frame: At baseline and at 6 months
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
Time Frame: At baseline and at 6 months
Z-score BMI for age of comparing the Group 1 and Group 2.
At baseline and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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