AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents

Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in athletes, even if those complaining allergic symptoms do not always receive a medical diagnosis. Many athletes already start competitive sport activities in pediatric age, but allergy screening tests are usually not performed when assessing eligibility to sport practice. Therefore, the objective of the present study is assessing the predictive ability of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic status in young athletes.

Study Overview

• Status: Completed
• Conditions: Young Athletes
• Intervention / Treatment: Diagnostic test: Questionnaire AQUA©, pediatric version

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Athletes aged 7 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).

Description

Inclusion Criteria:

- Athletes, males or females, 7 to 14 years old

Exclusion Criteria:

• Use of systemic antihistamines or long term or high dose corticosteroids in the last two weeks;
• Poor understanding of written or spoken Italian;
• Lack of written informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children	Diagnostic test: Questionnaire AQUA©, pediatric version; A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.
Adolescents	Diagnostic test: Questionnaire AQUA©, pediatric version; A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atopic status	Having at least 1 positive skin prick test to common aero-allergens	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological well-being	Percentage score from the WHO-5 questionnaire for measuring psychological well-being. The questionnaire is composed of 5 questions scored on a scale ranging from 0 (worse outcome) to 5 (best outcome). The total (raw) score is obtaining by summing all the individual score items, therefore it ranges from 0 (worse outcome) to 25 (best outcome). To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible outcome, whereas a score of 100 represents best possible outcome.	Day 0

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

General Publications

• Fasola S, Ferrante G, Malizia V, Bommarito N, Del Giacco S, Bonini M, Baiardini I, Bellafiore M, La Grutta S. Validity and repeatability of the Pediatric Allergy Questionnaire for Athletes (AQUAped) for the screening of atopy. Pediatr Allergy Immunol. 2021 Apr;32(3):437-444. doi: 10.1111/pai.13410. Epub 2020 Dec 2.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 01/2019

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