UMIN-CTR Clinical Trial

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 Keiko Middle name Last name Nakamura
Organization	Tokyo Medical and Dental University
Division name	Department of Global Health Entrepreneurship
Zip code	113-8519
Address	Tokyo
TEL	03-5803-4048
Email	nakamura.ith@tmd.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Nakamura
Organization	Tokyo Medical and Dental University
Division name	Department of Global Health Entrepreneurship
Zip code	113-8519
Address	Tokyo
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	Tokyo Medical and Dental University, Faculty of Medicine, IRB
Address	Yushima 1-5-45, Bunkyo-ku
Tel	03-3813-6111
Email	syomu1.adm@tmd.ac.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	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	648
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	Completed
Date of protocol fixation	2017 Year 11 Month 16 Day
Date of IRB	2017 Year 12 Month 19 Day
Anticipated trial start date	2018 Year 01 Month 08 Day
Last follow-up date	2022 Year 03 Month 31 Day
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	2022 Year 03 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034263