Health Promotion and Management for Hepatitis B Carriers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065363
Recruitment Status : Unknown
Verified February 2010 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2010
Last Update Posted : February 9, 2010
National Taiwan University
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Behavioral: standardized exercise program and dietary counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus
Study Start Date : August 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle conseling Behavioral: standardized exercise program and dietary counseling
Lecture, 12 weeks Standardized exercise program, 12 weeks Dietary counseling, 12 weeks Information platform, 12 weeks

Primary Outcome Measures :
  1. Reduction of relative serum HBV DNA levels [ Time Frame: three months ]

Secondary Outcome Measures :
  1. anthropometric index [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065363

National Taiwan University Health Center
Taipei, Taiwan, 10617
Sponsors and Collaborators
National Taiwan University Hospital
National Taiwan University
Principal Investigator: Jin-Shin Lai, MD Department of physical medicine and rehabilitation

Additional Information:
Responsible Party: Jin-Shin Lai/ Attending physician, Department of physical medicine and rehabilitation Identifier: NCT01065363     History of Changes
Other Study ID Numbers: 200906036R
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: February 2010

Keywords provided by National Taiwan University Hospital:
Hepatitis B virus DNA
Metabolic factor
Body mass index
Insulin resistance
Lifestyle factor
Preventive Medicine
Health Promotion

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections