- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848900
Guangzhou Outdoor Activity Longitudinal Study
November 19, 2010 updated by: Sun Yat-sen University
A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-onset Myopia in Chinese Children
The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.
Study Overview
Detailed Description
- To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.
- To identify the risk factors associated with the development and progression of juvenile-onset myopia.
- To characterize the interaction between refractive error and education.
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Zhongshan Ophthalmic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All the students in Grade 1
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Outdoor activity
Adding 1 hour outdoor time into school curricula
|
Adding 1 hour outdoor time into school curricula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cycloplegic refraction
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual acuity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mingguang He, PhD, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.
- Zhou Z, Morgan IG, Chen Q, Jin L, He M, Congdon N. Disordered sleep and myopia risk among Chinese children. PLoS One. 2015 Mar 26;10(3):e0121796. doi: 10.1371/journal.pone.0121796. eCollection 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
April 1, 2012
Study Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
November 22, 2010
Last Update Submitted That Met QC Criteria
November 19, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOAL2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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