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Physiologic and related behavioral outcomes from the Women's Lifestyle Heart Trial |
Toobert DJ, Glasgow RE, Radcliffe JL |
Annals of Behavioral Medicine 2000 Mar;22(1):1-9 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
The Women's Lifestyle Heart Trial was a small (n = 28) randomized controlled trial to evaluate the effects of a comprehensive lifestyle self-management program (very low-fat vegetarian diet, stress-management training, exercise, group support, and smoking cessation) on reduction of cardiovascular risk factors in postmenopausal women with coronary heart disease (CHD). Women assigned to the treatment condition (Prime Time) participated in a week-long retreat followed by twice-weekly 4-hour meetings. Endpoints were program adherence; changes in lipid profiles, body mass, blood pressure, hypolipidemic and antihypertensive medications; and quality of life. Risk factor and psychosocial evaluations were conducted at baseline and at 4, 12, and 24 months. Repeated measures analyses of covariance revealed that the dietary, stress management, and physical activity changes made by intervention women were dramatic and lasting. There were significantly greater improvements in the Prime Time condition compared to the usual care control group on body mass, angina symptoms, and quality of life, and a tendency for a greater reduction in blood pressure-lowering medications. Similar patterns were seen in lipids, blood pressure, and lipid-lowering medications, but did not reach significance. These results demonstrate that postmenopausal CHD women can make lasting lifestyle changes, and that these changes may reduce the need for cardiac medications and improve CHD risk factors and quality of life.
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