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Guangzhou Outdoor Activity Longitudinal Study

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ClinicalTrials.gov Identifier: NCT00848900
Recruitment Status : Unknown
Verified October 2010 by Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
First Posted : February 20, 2009
Last Update Posted : November 22, 2010
Sponsor:
Information provided by:
Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE February 19, 2009
First Posted Date  ICMJE February 20, 2009
Last Update Posted Date November 22, 2010
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
Cycloplegic refraction [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Visual Acuity [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
Visual acuity [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Refractive error [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
Detailed Description
  1. To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.
  2. To identify the risk factors associated with the development and progression of juvenile-onset myopia.
  3. To characterize the interaction between refractive error and education.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Myopia
Intervention  ICMJE Behavioral: Outdoor activity
Adding 1 hour outdoor time into school curricula
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Outdoor activity
    Adding 1 hour outdoor time into school curricula
    Intervention: Behavioral: Outdoor activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2010)
2000
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2009)
1500
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All the students in Grade 1

Exclusion Criteria:

  • No
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848900
Other Study ID Numbers  ICMJE GOAL2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mingguang He, Zhongshan Ophthalmic Center, ZOC
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mingguang He, PhD, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP