This trial is active, not recruiting.

Condition chronic hepatitis b
Treatment standardized exercise program and dietary counseling
Sponsor National Taiwan University Hospital
Collaborator National Taiwan University
Start date August 2009
End date July 2010
Trial size 160 participants
Trial identifier NCT01065363, 200906036R


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
standardized exercise program and dietary counseling
Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks

Primary Outcomes

Reduction of relative serum HBV DNA levels
time frame: three months

Secondary Outcomes

anthropometric index
time frame: three months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus
Principal investigator Jin-Shin Lai, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.