Health Promotion and Management for Hepatitis B Carriers

Study Overview
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Brief Summary
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The investigators propose a project of preventive medicine with concern of local context in Taiwan. The target population includes all staff and faculty members, students, and alumni of a university in Northern Taiwan, with chronic hepatitis B infection. The intervention of this project includes standardized lectures, sports courses, nutrition courses, and an information platform. The investigators will evaluate the efficacy after the intervention, like the reduction of hepatitis B viral load and the associated anthropometric parameters. The results of this project will be initially served as a pilot study for this cohort, and applicated as a promising basis for health promotion.

Official Title
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Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Behavioral: standardized exercise program and dietary counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants were recruited from students, alumni, faculty and staff members with chronic HBV infection (positive HBsAg serostatus ≥6 months) in a university of northern Taiwan from August 1, 2009 to July 01, 2010. Only participants aged 18 and older were included. Exclusion Criteria: Excluded were: (a) those who had been diagnosed as chronic liver diseases like chronic hepatitis C infection (Anti-HCV (+)), autoimmune hepatitis, Wilson disease, alcoholic liver diseases, drug-related hepatitis, decompensated liver diseases, cirrhosis, or malignant hepatic tumors; (b) those who had undergone liver transplantation or major operations for liver except cholecystectomy; (c) men who consumed more than 30 gram of alcohol per week or women who consumed more than 20 gram of alcohol per week; (d) women who were pregnant; (e) those who had current medications for any types of chronic diseases except for hyperglycemia, elevated blood pressure, or dyslipidemia within six months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle conseling<br> | Behavioral: standardized exercise program and dietary counseling<br>* Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of relative serum HBV DNA levels |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric index |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B virus DNA, Metabolic factor, Body mass index, Obesity, Insulin resistance, Lifestyle factor, Preventive Medicine, Health Promotion