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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030003
Receipt No. R000034263
Scientific Title Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases
Date of disclosure of the study information 2017/11/16
Last modified on 2018/05/17

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Basic information
Public title Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases
Acronym Hue Adolescents Healthy Vision Cohort Study
Scientific Title Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases
Scientific Title:Acronym Hue Adolescents Healthy Vision Cohort Study
Region
Asia(except Japan)

Condition
Condition Myopia, Non-communicable diseases
Classification by specialty
Pediatrics Ophthalmology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the risk factors of refractive errors, obesity and underweight in adolescents in Hue, Vietnam.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Status of refractive error and its changes in 36 months
Key secondary outcomes Body Mass Index (BMI) and changes of BMI in 36 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Examination of visual acuity, refractive errors, axial length, height and weight at one day at the initial contact.
Interventions/Control_2
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
11 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria The first grade student in a secondary school
Be able to communicate with and read in Vietnamese
Submission of informed consent and assent
Key exclusion criteria Student absent on the exanination day
Student who didn't agree to join the study
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Nakamura
Organization Tokyo Medical and Dental University
Division name Department of Global Health Entrepreneurship
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4048
Email nakamura.ith@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Nakamura
Organization Tokyo Medical and Dental University
Division name Department of Global Health Entrepreneurship
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4048
Homepage URL
Email nakamura.ith@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Grants in Aid for Scientific Research, Japan Society for Promotion of Science, MEXT, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Hue University of Medicine and Pharmacy
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Nguyen Chi Dieu Secondary School (Hue, Vietnam), Truong THCS Nguyen Thi Minh Khai Secondary School (Hue, Vietnam), Thong Nhat Secondary School (Hue, Vietnam), Ham Nghi Secondary School (Hue, Vietnam), Nguyen Du Secondary School (Hue, Vietnam)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 16 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 16 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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