Framingham Cycle V Offspring-Spouse Nutrition Studies
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005347
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005347
Brief Title
Framingham Cycle V Offspring-Spouse Nutrition Studies
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
February 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1997 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Obesity, Diabetes Mellitus, Atherosclerosis
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
7359634
Citation
Drach GW. Urinary lithiasis. J Urol. 1980 Mar;123(3):348. doi: 10.1016/s0022-5347(17)55928-5. No abstract available.
Results Reference
background
PubMed Identifier
7852683
Citation
Posner BM, Franz MM, Quatromoni PA, Gagnon DR, Sytkowski PA, D'Agostino RB, Cupples LA. Secular trends in diet and risk factors for cardiovascular disease: the Framingham Study. J Am Diet Assoc. 1995 Feb;95(2):171-9. doi: 10.1016/S0002-8223(95)00043-7.
Results Reference
background
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Framingham Cycle V Offspring-Spouse Nutrition Studies
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