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Lifestyle Management for Women With CHD and NIDDM

This study has been completed.
Study NCT00005441.   Last updated on June 23, 2005.   Information provided by National Heart, Lung, and Blood Institute (NHLBI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Lifestyle Management for Women With CHD and NIDDM
Official Title 
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.

Study Phase
Study Type  Observational
Study Design  Natural History, Longitudinal
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cardiovascular Diseases
Coronary Disease
Heart Diseases
Diabetes Mellitus, Non-Insulin Dependent
Postmenopause
Diabetes Mellitus
Intervention 
MEDLINE PMIDs 9887850
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  April 1993
Completion Date March 1998
Eligibility Criteria 

No eligibility criteria

Gender Female
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00005441
Organization ID 4370
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date September 2002
First Received Date  May 25, 2000
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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