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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005509 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cardiovascular Risk Factors in a Cohort of Latina Women | ||||
| Official Title ICMJE | |||||
| Brief Summary | To conduct a cross-sectional study of cardiovascular risk factors in a cohort of Latina women. |
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| Detailed Description | BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death among Latina women (LW) in the United States. Nursing knowledge in the area of CVD and Latina women is currently underdeveloped. Most studies have included Mexican women with limited information on how predictors such as resources, situational, personal, and demographic factors have an effect on the CVD-related dietary practices, physical activity, and exercise practices among Latina women subgroups such as Central American women. DESIGN NARRATIVE: To conduct a cross-sectional and follow-up preliminary intervention study in order to describe and analyze the CVD-related diet, physical activity, and exercise practices predictors in 221 Mexican and Central American women recruited from six counties in Northern California. Face-to-face interviews were conducted with Mexican American and Central American women (ages 40-75) who had at least one risk factor for CVD to answer the following questions: What were the CVD-related risk factors, dietary practices, physical activity, and exercise behaviors in Mexican and Central American women who were 40 to 75 years and who had at least one risk factor for CVD? What was the relationship between predictor variables (resources, situational, personal, and demographic factors) with CVD-related diet practices, physical activity, and exercise behaviors (outcome variables)?, and what were the short and intermediate-term effects of a cardiovascular nursing intervention on diet, physical activity, and exercise? A sample of 221 women was targeted. Data were collected during the first two years of the project to provide substantial research-based information to develop a cardiovascular nursing intervention to support Latina women efforts to promote heart health and prevent CVD. Data were analyzed during the third year and the cardiovascular nursing intervention was developed to determine the short (3 months) and intermediate-term (6 months) effects in the outcome variables. A randomly selected sample of 60 women from the same cohort was randomly assigned to the developed intervention group (n=30 in each group) and to a delayed-intervention control group. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | March 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005509 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5027 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | December 2004 | ||||
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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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