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| Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease |
| Toobert DJ, Glasgow RE, Nettekoven LA, Brown JE |
| Patient Education and Counseling 1998 Nov;35(3):177-188 |
| clinical trial |
| 4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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* |
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Females, especially older women, historically have been excluded from coronary heart disease (CHD) studies. The PrimeTime program was a randomized clinical trial designed to study the effects of a comprehensive lifestyle management program (very low-fat vegetarian diet, smoking cessation, stress-management training, moderate exercise, and group support) on changes in behavioral risk factors among postmenopausal women with CHD. The study also explored program effects on four psychosocial clusters: coping with stress, distress, social support, and self-efficacy. The program produced significant behavioral improvements in 4- and 12-months adherence to diet, physical activity, and stress-management in the PrimeTime women compared to the usual care (UC) group. In addition, the PrimeTime participants demonstrated improvements relative to UC on psychosocial measures of self-efficacy, perceived social support, and ability to cope with stress. Strengths and weaknesses of the study, and implications for future research are discussed.
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