NCT00005441

Brief Summary

To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat vegetarian diet, smoking cessation and stress management training) for postmenopausal women with coronary heart disease and Type II (non-insulin dependent) diabetes.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1993

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1993

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1997

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1998

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

4.5 years

First QC Date

May 25, 2000

Last Update Submit

February 4, 2016

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

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

Sponsors & Collaborators

Related Publications (1)

  • Toobert DJ, Glasgow RE, Nettekoven LA, Brown JE. Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease. Patient Educ Couns. 1998 Nov;35(3):177-88. doi: 10.1016/s0738-3991(98)00074-3.

    PMID: 9887850BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesDiabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

April 1, 1993

Primary Completion

October 1, 1997

Study Completion

March 1, 1998

Last Updated

February 8, 2016

Record last verified: 2016-02