Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00434

2 Trial Registration Date

2014-09-22

i Registration Status

Prospective

3 Secondary IDs

HASC/Student/13-14/047

4 Source(s) of Funding

Hong Kong Baptist University

5 Primary Sponsor

Lau Wing Chung, Patrick

6 Secondary Sponsor

Wang Jing jing

Function

Please specify

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

i Name

Wang Jing jing

ii Address

AAB927, 15 Hong Kong Baptist University Rd, Kowloon Tong, KLN, HK

iii Phone

852 34116405

iv Email

12466107@life.hkbu.edu.hk

v Affiliation

Department of Physical Education

vi Country

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

i Name

Lau Wing Chung, Patrick

ii Address

AAB1130, 15 Hong Kong Baptist University Rd, Kowloon Tong, KLN, HK

iii Phone

852 34115634

iv Email

wclau@hkbu.edu.hk

v Affiliation

Department of Physical Education

vi Country

9 Official Scientific Title of the Study

The effects of a health video game with story immersion for behavior change
in obesity prevention among Hong Kong Chinese children

10 Public Title

N/A

i Public Title in Chinese 研究名稱

有故事線的健康視頻遊戲促進學生合理飲食、增強體力活動量、預防肥胖的研究

11 Short Title (Optional)

'Escape from Diab' for childhood obesity intervention

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-06-24

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Obesity prevention

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

A health video with story immersion, named "Escape from Diabetes". Diab, to be played first, addresses diet and PA separately. The video games have different story lines, characters, and approaches. The stories, written by professional writers, were developed using comments and suggestions from focus group testing of potential characters and story lines.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

9 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The video game consists of nine episodes and children will play one episode per week. The intervention will be lasted for 9 weeks. Children will be randomized allocated into the intervention group and the control group. Participants in the intervention group will access to ‘Diab’ during the program time. Each week, children will play one episode and then go to the following episode next week. Children will play game during 45 minutes session every time. No intervention in the control group

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

The children aged 10~12 years old

ii Exclusion Criteria

Any physical and psychological illness that may prevent them from playing video and participating in PA will be excluded.

iii Age Minimum

10

iv Age Maximum

12

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

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

2014-10-06

21 Target Sample Size

168

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

BMI, Motivation and self-efficacy on food, water , fruit and physical activity at week 10

24 Secondary Outcome

Food intake preference, Physical activity level by questionnaire and accelerometer at week 10

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

N/A

26 Last Update Date

2015-10-22

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-14005354

28 Date of Registration in Primary Registry

2014-10-20

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-11-21