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Framingham Cycle V Offspring-Spouse Nutrition Studies

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ClinicalTrials.gov Identifier: NCT00005347
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : May 13, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date May 13, 2016
Study Start Date February 1992
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Framingham Cycle V Offspring-Spouse Nutrition Studies
Official Title Not Provided
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Hypertension
  • Obesity
  • Diabetes Mellitus
  • Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date January 1997
Primary Completion Date Not Provided
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005347
Other Study ID Numbers 4216
R01HL046193 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date May 2000