Guangzhou Outdoor Activity Longitudinal Study
This study is enrolling participants by invitation only.
Sponsor:
Sun Yat-sen University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00848900
First received: February 19, 2009
Last updated: November 19, 2010
Last verified: October 2010
| Tracking Information | |||||
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| First Received Date ICMJE | February 19, 2009 | ||||
| Last Updated Date | November 19, 2010 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cycloplegic refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00848900 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Refractive error [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Guangzhou Outdoor Activity Longitudinal Study | ||||
| Official Title ICMJE | A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-onset Myopia in Chinese Children | ||||
| Brief Summary | 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. |
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| Detailed Description |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Myopia | ||||
| Intervention ICMJE | Behavioral: Outdoor activity
Adding 1 hour outdoor time into school curricula |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2000 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00848900 | ||||
| Other Study ID Numbers ICMJE | GOAL2009 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mingguang He, Zhongshan Ophthalmic Center, ZOC | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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