Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00376

2 Trial Registration Date

2013-08-07

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

HMRF

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

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, Prince of Wales Hospital

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

Dorothy Chan

ii Address

Department of Paediatrics, 6/F, Clinical Sciences Building, Prince of Wales Hospital

iii Phone

26322982

iv Email

cfy320@gmail.com

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Lifestyle intervention in obese Chinese adolescents with nonalcoholic fatty liver disease: A randomized controlled study

10 Public Title

Lifestyle intervention in obese Chinese adolescents with nonalcoholic fatty liver disease: A randomized controlled study

i Public Title in Chinese 研究名稱

華裔肥胖青少年非酒精性脂肪肝生活方式干預效果研究

11 Short Title (Optional)

Lifestyle intervention in obese Chinese adolescents with nonalcoholic fatty liver disease

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?

2011-11-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Nonalcoholic fatty liver disease

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

A lifestyle modification programme (LMP) developed by the Centre for Nutritional Studies of The Chinese University of Hong Kong for the treatment of obesity and obesity-related diseases. It is clinically proven and developed based on motivational interviewing and behavioural modification, to accompany improving knowledge regarding diet and exercise.
Lifestyle intervention with modification of diet, physical activity and behaviour patterns that have been shown to be effective among adults could reduce the severity and prevalence of nonalcoholic fatty liver disease (NAFLD) in obese children and adolescents

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During the first 16 weeks, subjects in the LMP intervention group will come for counselling sessions

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Intervention group will receive the intervention just after randomization. The control group will receive the conventional care with follow-up in the Obesity and Lipid Disorder Clinic every 16 weeks. During the first 16 weeks, subjects in the LMP intervention group will come for counselling sessions weekly and then bi-monthly for one year. During the initial assessment (~1.5 hour) with the parent-child pair, the dieticians/nutritionists will carry out a complete behavioural assessment of the child and collect important information, such as medical history, current eating and lifestyle patterns and readiness to change. The dieticians will also discuss with the child and their parents the expected duration and specific dietary and lifestyle advice to achieve a desirable weight status. During the follow up counselling (15 to 20 minutes), the dieticians will review the weekly seven-day food record to check compliance on diet, exercise adherence and progression. The dieticians will review food records to ensure nutritional adequacy and offer dietary recommendations. The dietary component and portion sizes of the programme are based on American Dietetic Association, with 20% caloric restriction as appropriate to the individual. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat, low-glycaemic index and low calorific products in appropriate portions are encouraged. The dieticians/nutritionists will also perform motivational interviewing, such as discussing barriers to lifestyle change and child’s and parents’ feelings about the progress. Each subject will be provided with a booklet for portion size exchange and tips for eating out. The dieticians will encourage them to bring new food products and restaurant menu to discuss and explore healthy choices, and to send their enquiries to them by email or phone regularly. Moreover, parents will be encouraged to come with their child for the dietary counselling and to discuss family factors or barriers to lifestyle change.

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

Post-pubertal Chinese adolescents aged 14 -18 years with primary obesity attending the Obesity and Lipid Disorder Clinic in Prince of Wales Hospital.
Signed informed consent by parents and assent by children

ii Exclusion Criteria

Hepatic viral infection
Daily usage of alcohol, from parental or self-report
BMI below 95th centile of local reference
Using steatogenic and /or anti-diabetic drugs
Concurrent participation in any clinical trial, dietary intervention or weight loss program
Concomitant intake of a weight reducing agent
Any chronic medical illness
Unwillingness to attend regular follow up appointments as part of the intervention programme

iii Age Minimum

14 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

Single-blind

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

2014-01-02

21 Target Sample Size

56 subject

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

To determine the degree of change of intrahepatic triglyceride content of NAFLD after intervention.

24 Secondary Outcome

Anthropometric measurements and blood tests will be performed at baseline, after 16 weeks intervention and at 12 months follow-up after intervention.
Anthropometric measurements: height, weight, body fat and waist circumference
Blood tests: plasma fasting glucose, lipid profile, plasma alanine aminotransferase (ALT), aspirate aminotransferase (AST) and serum insulin.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003501

28 Date of Registration in Primary Registry

2013-08-21

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-08-27