Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 31, 2010 | ||||
| Last Updated Date | December 1, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
lifestyle [ Designated as safety issue: No ] physical activity, dietary, depression, anxiety |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01136343 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women | ||||
| Official Title ICMJE | Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women | ||||
| Brief Summary | In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Other: lifestyle modified project
education, counseling |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 130 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 40 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01136343 | ||||
| Other Study ID Numbers ICMJE | 99001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jeng Chii, Taipei Medical University / College of Nursing | ||||
| Study Sponsor ICMJE | Taipei Medical University WanFang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taipei Medical University WanFang Hospital | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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