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Trial History Detail on 2013-08-27

CUHK_CCT00376

2013-08-07

Prospective

Nil

HMRF

Nil

Nil

Hung-kwan So

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

26322829

sohk@cuhk.edu.hk

The Chinese University of Hong Kong

Dorothy Chan

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

26322982

cfy320@gmail.com

The Chinese University of Hong Kong

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

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

華裔肥胖青少年非酒精性脂肪肝生活方式干預效果研究

Lifestyle intervention in obese Chinese adolescents with nonalcoholic fatty liver disease

Hong Kong SAR, China

Yes

2011-11-02

Nonalcoholic fatty liver disease

Behavior

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

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

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.

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

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

14 years old

18 years old

Both Male and Female

Interventional

Randomized

Placebo

Single-blind

Parallel

2014-01-02

56 subject

Not Yet Recruiting

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

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.

No

2015-04-18

ChiCTR-TRC-13003501

2013-08-21


No

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