Back to resultsHealth Promotion and Management for Hepatitis B Carriers
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
standardized exercise program and dietary counseling
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Hepatitis B focused on measuring Hepatitis B virus DNA, Metabolic factor, Body mass index, Obesity, Insulin resistance, Lifestyle factor, Preventive Medicine, Health Promotion
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle conseling
Arm Description
Outcomes
Primary Outcome Measures
Reduction of relative serum HBV DNA levels
Secondary Outcome Measures
anthropometric index
Full Information
NCT ID
NCT01065363
First Posted
February 8, 2010
Last Updated
February 8, 2010
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University
1. Study Identification
Unique Protocol Identification Number
NCT01065363
Brief Title
Health Promotion and Management for Hepatitis B Carriers
Official Title
Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B virus DNA, Metabolic factor, Body mass index, Obesity, Insulin resistance, Lifestyle factor, Preventive Medicine, Health Promotion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle conseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
standardized exercise program and dietary counseling
Intervention Description
Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks
Primary Outcome Measure Information:
Title
Reduction of relative serum HBV DNA levels
Time Frame
three months
Secondary Outcome Measure Information:
Title
anthropometric index
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shin Lai, MD
Organizational Affiliation
Department of physical medicine and rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Health Center
City
Taipei
ZIP/Postal Code
10617
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://ann.cc.ntu.edu.tw/asp/ShowContent.asp?num=16309
Description
Related Info
Learn more about this trial
Health Promotion and Management for Hepatitis B Carriers
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