Lifestyle Management for Women With CHD and NIDDM
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005441
First Posted
May 25, 2000
Last Updated
February 4, 2016
Sponsor
Oregon Research Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005441
Brief Title
Lifestyle Management for Women With CHD and NIDDM
Study Type
Observational
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 1993 (undefined)
Primary Completion Date
October 1997 (Actual)
Study Completion Date
March 1998 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
BACKGROUND:
Coronary heart disease is the leading cause of death among postmenopausal women. Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women, especially as a result of comprehensive lifestyle changes. A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women.
DESIGN NARRATIVE:
The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred. Its generalizability and applicability -- especially for high-risk women --was uncertain. The program was compared to a usual care condition in an initial randomized trial. Outcome measures included patient self-care behaviors and health outcomes (serum lipid profiles, blood pressure, relative weight, and glycemic control). Process measures included self-efficacy, personal health models, perceived stress, social support and problem-solving skills. Subjects participated in the intervention for three years, with gradual fading of the program in the third year to evaluate the long-term effects of the program. Analyses included assessments of between groups differences on physiological risk factors, behavioral (lifestyle) measures and process measures as well as maintenance over time. Based upon the results of this study, the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Postmenopause, Diabetes Mellitus
7. Study Design
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9887850
Citation
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.
Results Reference
background
Learn more about this trial
Lifestyle Management for Women With CHD and NIDDM
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