Framingham Cycle V Offspring-Spouse Nutrition Studies

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005347
• Other study ID #: 4216
• Secondary ID: R01HL046193
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: February 1992
• Est. completion date: January 1997

Study information

• Verified date: May 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Diseases
• Hypertension
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Drach GW. Urinary lithiasis. J Urol. 1980 Mar;123(3):348. — View 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. — View Citation