Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00149

2 Trial Registration Date

2008-02-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Oxford University - Li Ka Shing Foundation

5 Primary Sponsor

Professor Nathan Congdon, Department of Ophthalmology and Visual Science

6 Secondary Sponsor

Professor Sian Griffiths, Department of Public Health

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Nathan Congdon

ii Address

iii Phone

7/F, Block B, Department of Ophthalmology and Visual Science, Prince of Wales Hospital, Shatin NT

iv Email

NCONGDON@CUHK.EDU.HK , Ph. 6113 4445

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Nathan Congdon

ii Address

iii Phone

7/F, Block B, Department of Ophthalmology and Visual Science, Prince of Wales Hospital, Shatin NT

iv Email

NCONGDON@CUHK.EDU.HK , Ph. 6113 4445

v Affiliation

vi Country

9 Official Scientific Title of the Study

A randomized trial of interventions to promote spectacle wear and improved health behaviours among rural Chinese school children

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-09-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Refractive error, physical activity, obesity

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

a. Ocular intervention • School-based assessment of vision by & automatic refraction with cycloplegic refinement by study optometrist at school • Opportunity for child to make a choice of frames • Classroom-based educational intervention - on the meaning of myopia, benefits of spectacle wear, correction of common mis-conceptions about glasses • Provision of parental information sheet • Home visit by ¡§Vision Entrepreneurs¡¨ b. Ocular intervention ¡§plus¡¨¡XAbove plus health education interventions on: • Diet, obesity and weight control • Smoking c. Control • School-based assessment of vision by & automatic refraction with cycloplegic refinement by study optometrist at school

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Children of consenting parents, aged 13 to 18 years, in Middle or High School at schools within 10 km of optometric facilities at Caring is Hip centers in Fuyang, Liangying, and Xichang. Exclusion criteria: Failure to obtain parental consent

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-11-01

21 Target Sample Size

5000

22 Recruitment Status

Recruiting

23 Primary Outcome

A. Vision-related: - at 6 months and 1 year post visit to schools • Prevalence of refractive error and need for spectacles • Proportion of children requiring refractive correction who have obtained it at baseline • Determinants of glasses wear at baseline • Behaviorial and familial risk factors for myopia • Visual function and healthy behaviour knowledge pre and post-intervention, compared to control schools • Uptake of spectacles among children with refractive error, comparing the control and ocular interventions • Other determinants of spectacle uptake • Impact of spectacle uptake on visual function and school performance outcomes • Barriers to parents in providing glasses

24 Secondary Outcome

B. Outcomes related to other proposed health interventions ¡V at 6 months and 1 year post visit to schools • Changes in attitude/behaviour post-intervention, compared to control schools • Smoking rates and changes in attitude/behaviour post-intervention, compared to control schools • Social marketing approaches will be tested out and assessed for their impact

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2008-02-13