NCT02271373

Brief Summary

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors in northeast China.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,521

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

October 19, 2014

Last Update Submit

October 22, 2014

Conditions

Keywords

Vision, OcularPhysical activitySchoolchildrenIntervention Studies

Outcome Measures

Primary Outcomes (1)

  • Changes in uncorrected visual acuity

    Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases).All the measurements were recorded.

    Baseline, Month 6, Month 12

Secondary Outcomes (2)

  • Questionnaire survey

    Baseline

  • Changes in ocular biometric parameters

    Baseline, Month 12

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.

Behavioral: increasing time spent outdoors

control group

NO INTERVENTION

The control school did not have any interventions.

Interventions

The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.

intervention group

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Grade of 1 to 5 in elementary schools and grade of 7 to 8 in secondary schools.

You may not qualify if:

  • Visual defect or other eye diseases; wearing orthokeratology; refractive surgery history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jin JX, Hua WJ, Jiang X, Wu XY, Yang JW, Gao GP, Fang Y, Pei CL, Wang S, Zhang JZ, Tao LM, Tao FB. Effect of outdoor activity on myopia onset and progression in school-aged children in northeast China: the Sujiatun Eye Care Study. BMC Ophthalmol. 2015 Jul 9;15:73. doi: 10.1186/s12886-015-0052-9.

MeSH Terms

Conditions

MyopiaMotor Activity

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesBehavior

Study Officials

  • Fangbiao Tao, PhD

    Department of Maternal, Child and Maternal Health, School of Public Health, Anhui Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of School of Public Health, Anhui Medical University

Study Record Dates

First Submitted

October 19, 2014

First Posted

October 22, 2014

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

October 23, 2014

Record last verified: 2014-10