NCT00000598

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1991

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1991

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1996

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

January 12, 2016

Status Verified

March 1, 2005

First QC Date

October 27, 1999

Last Update Submit

January 8, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesHypercholesterolemiaPostmenopause

Interventions

diet, fat-restrictedBEHAVIORAL
exerciseBEHAVIORAL

Eligibility Criteria

Age30 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Stefanick ML, Mackey S, Sheehan M, Ellsworth N, Haskell WL, Wood PD. Effects of diet and exercise in men and postmenopausal women with low levels of HDL cholesterol and high levels of LDL cholesterol. N Engl J Med. 1998 Jul 2;339(1):12-20. doi: 10.1056/NEJM199807023390103.

    PMID: 9647874BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypercholesterolemia

Interventions

Diet, Fat-RestrictedExercise

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter Wood

    Stanford University

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1991

Study Completion

August 1, 1996

Last Updated

January 12, 2016

Record last verified: 2005-03