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Diet and Exercise for Elevated Risk (DEER)

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ClinicalTrials.gov Identifier: NCT00000598
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Stanford University

Brief Summary:
To determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education Program (NCEP) Step Two diet compared to usual care control group on HDL- and LDL-cholesterol.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Hypercholesterolemia Postmenopause Behavioral: diet, fat-restricted Behavioral: exercise Phase 3

Detailed Description:

BACKGROUND:

The NCEP is a major public education program providing advice to physicians and the public on management and prevention of coronary heart disease. However, data supporting the advice are derived primarily from middle-aged men, with less data available for women and older individuals. Furthermore, there have been recent reports that when low saturated fat diets such as the NCEP Step One and NCEP Step Two diets, are followed, HDL-cholesterol is lowered as well as LDL-cholesterol.

DESIGN NARRATIVE:

Randomized, controlled, factorial design powered for men and women separately. One hundred eighty postmenopausal women, 45 through 64 years of age, and 197 men, 30 through 64 years of age, who had low high-density lipoprotein (HDL) cholesterol levels (< or =59 mg per deciliter in women and < or =44 mg per deciliter in men) and moderately elevated levels of low-density lipoprotein (LDL) cholesterol (>125 mg per deciliter but <210 mg per deciliter in women and >125 mg per deciliter but <190 mg per deciliter in men) were enrolled. The subjects were randomly assigned to aerobic exercise, the NCEP Step 2 diet, or diet plus exercise, or to a control group, which received no intervention. The four interventions were delivered for one year: usual care (written dietary materials only with delayed intervention optional), exercise only (supervised, progressive aerobic exercise program at least three times per week), diet only (group and individual dietary instruction on the NCEP Step One/Step Two diet delivered by registered dietitians), and diet plus exercise. At baseline and at the end of one year, measurements were made of blood lipids and lipoproteins, plasma glucose and insulin, glucose tolerance, blood pressure, body composition through hydrostatic weighing and waist and hip circumterences, aerobic fitness (VO2 max), and five unannounced 24-hr. recalls. The primary outcomes measured was HDL-cholesterol, major secondary endpoints included LDL-C, LDL-C/HDL-C ratio, and triglycerides.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
Study Start Date : August 1991
Study Completion Date : August 1996

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men with with LDL-cholesterol of 125-189 mg/dL and HDL-cholesterol below or equal to 44 mg/dL, and postmenopausal women, age 45 to 64, with LDL-cholesterol of 125 to 209 mg/dL and HDL-cholesterol below or equal to 59 mg/dL.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000598


Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Peter Wood Stanford University

Publications:
ClinicalTrials.gov Identifier: NCT00000598     History of Changes
Other Study ID Numbers: 501
R01HL045733 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: March 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases