The Quality of Life of Mothers of Children With Food Allergy
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ClinicalTrials.gov Identifier: NCT04740632 |
Recruitment Status :
Recruiting
First Posted : February 5, 2021
Last Update Posted : September 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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Food Allergy | Behavioral: Personalized Nutritional Counseling by a multidisciplinary team | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy |
Actual Study Start Date : | January 10, 2022 |
Actual Primary Completion Date : | June 10, 2022 |
Estimated Study Completion Date : | January 10, 2023 |

Arm | Intervention/treatment |
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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..
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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.
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Behavioral: Personalized Nutritional Counseling by a multidisciplinary team
Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes |
- 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).
- 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).
- 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).
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Z-score weight for age Group 2 [ Time Frame: At baseline and at 6 months ]Z-score weight for age of the Group 2.
- Z-score length for age Group 2 [ Time Frame: At baseline and at 6 months ]Z-score length for age of the Group 2.
- Z-score BMI for age Group 2 [ Time Frame: At baseline and at 6 months ]Z-score BMI for age of the Group 2.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740632
Contact: Roberto Berni Canani, MD, PhD | 0817462680 | berni@unina.it |
Italy | |
Department of Traslational Medical Science - University of Naples Federico II | Recruiting |
Naples, Italy, 80131 | |
Contact: Roberto Berni Canani, MD, PhD 0817462680 berni@unina.it |
Responsible Party: | Roberto Berni Canani, MD, PhD, Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science, Federico II University |
ClinicalTrials.gov Identifier: | NCT04740632 |
Other Study ID Numbers: |
283/20 |
First Posted: | February 5, 2021 Key Record Dates |
Last Update Posted: | September 29, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |