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Home > "L" Clinical Trials Conditions > Lifestyle Management for Women with CHD and NIDDM  Lifestyle Management for Women with CHD and NIDDM
Lifestyle Management for Women with CHD and NIDDM
For Condition: Diabetes Mellitus, non-insulin dependent,Postmenopause,Coronary Disease,Diabetes Mellitus,Heart Diseases,Cardiovascular Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 4370;
Study Start Date: April 1993
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005441
Other Diabetes Mellitus, Non-Insulin Dependent Studies:
1. Women's Health Trial: Feasibility Study in Minority Populations
2. Women's Angiographic Vitamin and Estrogen Trial (WAVE)
3. Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
4. Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
5. Thrombotic, Inflammatory & Gene Markers of CVD in Women
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Lifestyle Management for Women with CHD and NIDDM
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