Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00342

2 Trial Registration Date

2012-10-25

i Registration Status

Prospective

3 Secondary IDs

10110911

4 Source(s) of Funding

Health and Health Services Research Fund

5 Primary Sponsor

Food and Health Bureau Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Hung-kwan So

ii Address

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

iii Phone

26322829

iv Email

sohk@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Edmund Anthony Nelson

ii Address

Department of Paediatrics, 6/F Clinical Sciences Building, PWH

iii Phone

26322861

iv Email

tony-nelson@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

10 Public Title

Lifestyle intervention using an internet-based curriculum with cell phone reminders among obese Chinese adolescents: A randomized controlled pilot study

i Public Title in Chinese 研究名稱

通過手機向肥胖青少年作提示互聯網生活方式干預方案的先導研究

11 Short Title (Optional)

Lifestyle intervention using an internet-based curriculum with cell phone

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-01-10

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Obesity

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Internet-based obesity prevention programs with cell phone follow up and family participation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 week internet curriculum and cell phone follow up over 24 weeks.

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

For this pilot study there will be one control group and two different intervention groups. The control group will also receive usual care which consists of visits to the obesity clinic staffed by a paediatrician every three months while the first intervention group will receive visits to the obesity clinic every 3 months plus 12 week internet curriculum and cell phone follow up over 24 weeks. The second intervention group will receive visits to the obesity clinic every three months and three meetings with a nutritionist over three months.

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

Adolescents aged 12-18 years with primary obesity attending the Obesity and Lipid Clinic at the Prince of Wales Hospital and signed informed consent by parents and teens.

ii Exclusion Criteria

BMI below 95th percentile of local reference, concurrent participation in any clinical trial, dietary intervention or weight loss program, concomitant intake of a weight reducing agent, any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study, unwillingness to attend regular follow up appointments as part of the intervention programme.

iii Age Minimum

12 years old

iv Age Maximum

18 Years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2013-02-01

21 Target Sample Size

48

22 Recruitment Status

Complete

23 Primary Outcome

To determine the feasibility of adapting and using an existing internet curriculum and nutritional program along with cell phone follow up for obese Hong Kong teens by examining recruitment and retention rate, internet log-in rate, compliance and satisfaction with counselling, curriculum and cell phone communication at 24 weeks

24 Secondary Outcome

To identify the feasibility of obtaining subjects’ physical activity level, dietary intake, stress level, and knowledge related to nutrition/physical activity, as well as weight and blood pressure and to determine the effect of the program on these indices at 24 weeks.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-11-21

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002624

28 Date of Registration in Primary Registry

2012-10-26

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Completed recruiting 48 subjects.

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Trial History Detail on 2013-11-21