UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053489 |
|---|---|
| Receipt number | R000060891 |
| Scientific Title | Questionnaire Study on Changes in Awareness and the Prevalence of Allergic Diseases Prevention after Health Guidance in the "Health Promotion Project for Allergy Prevention" |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/01/31 11:20:25 |
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Basic information
Public title
Questionnaire Study on Changes in Awareness and the Prevalence of Allergic Diseases Prevention after Health Guidance in the "Health Promotion Project for Allergy Prevention"
Acronym
Allergic Disease Questionnaire Study of Asahi City Health Promotion Project
Scientific Title
Questionnaire Study on Changes in Awareness and the Prevalence of Allergic Diseases Prevention after Health Guidance in the "Health Promotion Project for Allergy Prevention"
Scientific Title:Acronym
Allergic Disease Questionnaire Study of Asahi City Health Promotion Project
Region
| Japan |
Condition
Condition
Toddler and young children in general
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chiba University Hospital and Asahi City have entered into an agreement to carry out activities under the "Health Promotion Project for Allergy Prevention." The objective of this project is to assess the impact of these activities on the awareness and preventive efforts related to allergic diseases among Asahi citizens. This will be achieved through a questionnaire administered during group infant health checkups, aiming to elucidate the significance of health guidance and identify challenges for the potential expansion of this initiative in the future.
Basic objectives2
Others
Basic objectives -Others
No special notes
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in the prevalence of allergic diseases (food allergies, atopic dermatitis, bronchial asthma) at the 18-month and 3-year-old health checkups before and after the initiation of health guidance.
Key secondary outcomes
1.The implementation rates of health guidance content at the 4-month, 18-month, and 3-year health checkups before and after the initiation of health guidance.
2.The medical history of febrile convulsions, respiratory infections, and constipation until the 18-month and 3-year health checkups before and after the initiation of health guidance.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Regular health guidance not supervised by the "Health Promotion Project for Allergy Prevention" does not fall under the purview of this project.
Interventions/Control_2
Provide information and health guidance that are considered useful in preventing the onset of allergies under the supervision of the "Health Promotion Project for Allergy Prevention" through the following methods:
(1) Instruct on the importance of skincare and demonstrate skincare techniques during maternity clinics and infant health checkups.
(2) Advocate for the importance of vitamin D in preventing allergy development and encourage its intake.
(3) Conduct poster displays and distribute pamphlets at public facilities in Asahi City.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Before Commencement of Health Guidance Group
Parents of 1-year-olds and 3-year-olds who attended group infant health checkups (1.5-year health checkup and 3-year health checkup) in Asahi City during the one-year period after obtaining research approval.
2. After Commencement of Health Guidance Group
Parents of children who attended the following checkups:
(1) Group 4-month health checkups in Asahi City conducted between August 2024 and August 2025.
(2) Group 1.5-year health checkups in Asahi City conducted between October 2025 and October 2026.
(3) Group 3-year health checkups in Asahi City conducted between October 2027 and October 2028.
Key exclusion criteria
Individuals meeting any of the following criteria shall not be included in this study:
(1) Those who refuse to respond to the questionnaire.
(2) Others deemed inappropriate by the researchers or responsible parties conducting the study.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Nakano |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
0432227171
t-nakano@chiba-u.jp
Public contact
Name of contact person
| 1st name | Taiji |
| Middle name | |
| Last name | Nakano |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
0432227171
Homepage URL
https://www.m.chiba-u.jp/dept/pediatrics/chiba-21/
t-nakano@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Taiji Nakano
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kazusa DNA Research Institute
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
Tel
0432227171
t-nakano@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）、旭市役所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060891
