Health Promotion and Management for Hepatitis B Carriers

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01065363
• Other study ID #: 200906036R
• Status: Active, not recruiting
• Phase: N/A
• First received: February 8, 2010
• Last updated: February 8, 2010
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Behavioral:
• standardized exercise program and dietary counseling
Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Health Center	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of relative serum HBV DNA levels		three months	No
Secondary	anthropometric index		three months	No

External Links

•   Link