Health Promotion and Management for Hepatitis B Carriers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Taiwan University
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01065363
First received: February 8, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention
Chronic Hepatitis B
Behavioral: standardized exercise program and dietary counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project of Health Promotion and Management for Hepatitis B Carriers in NTU Campus

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Reduction of relative serum HBV DNA levels [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anthropometric index [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065363

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

Additional Information:
No publications provided

Responsible Party: Jin-Shin Lai/ Attending physician, Department of physical medicine and rehabilitation
ClinicalTrials.gov Identifier: NCT01065363     History of Changes
Other Study ID Numbers: 200906036R
Study First Received: February 8, 2010
Last Updated: February 8, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on April 22, 2014