Cardiovascular Diseases Clinical Trial
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.
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.
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