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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | February 1992 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005347 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Framingham Cycle V Offspring-Spouse Nutrition Studies |
| Official Title ICMJE | |
| Brief Summary | To examine the associations between diet, nutrition and coronary heart disease (CHD) incidence over seven years using the Cycle V Framingham Offspring/Spouse examination ; to examine the cross-sectional associations between dietary variables and major cardiovascular disease risk factors, to examine changes in dietary behaviors and their determinants over seven years; and to characterize the influences of dietary behavior changes on risk factor status between 1984-88 and 1991-94. |
| Detailed Description | DESIGN NARRATIVE: The data collection efforts and cross-sectional analyses were carried out among approximately 3800 males and females during the scheduled 1991-1994 Cycle V Framingham Offspring/Spouse study. The secular trend and longitudinal analyses also included data that were collected during the Cycle III Offspring/Spouse studies in 1984-88. Of particular interest were dietary variables which play a major role in serum total cholesterol and lipoprotein regulation. Additional dietary variables which were associated with major cardiovascular risk factors ((elevated) blood pressure, glucose (in)tolerance, (excess) body weight or physical (in)activity, and smoking) or that may predict CHD endpoints were included in the analyses. The potential confounding effects or interactions between dietary and risk factor variables were considered. Separate analyses were carried out in males and females. |
| 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 | January 1997 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| 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 | NCT00005347 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4216 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | May 2000 |
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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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