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
Recruitment status was Active, not recruiting
Sponsor:
National Taiwan University Hospital
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
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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:
MedlinePlus related topics:
Diabetes Medicines
Exercise and Physical Fitness
Hepatitis
Hepatitis A
Hepatitis B
U.S. FDA Resources
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 May 23, 2013