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This paper describes a randomized study to evaluate the effects of a comprehensive lifestyle management intervention for 279 postmenopausal women with type 2 diabetes who are at elevated risk for coronary heart disease (CHD). The intervention, called the Mediterranean Lifestyle Trial, is focused on dietary factors, physical activity, social support and stress management. The Mediterranean Lifestyle Trial relies on a synthesis of Social Cognitive Theory and Social Ecologic Theory, as well as goal-systems theory, to explicitly inform the lifestyle intervention and to address maintenance. Thus, the trial should help illuminate the theoretical mechanisms responsible for lifestyle change. Primary outcome variables are dietary, stress management and physical activity behavior change, quality of life, and CHD-related biological risk factors. Hypothesized mediating variables include self-efficacy, coping, and social and environmental support. Following the initial 6-month intervention, participants in the intervention condition are randomized to one of two groups designed to enhance maintenance of effects: either a peer-led support group or a personalized multilevel community resources maintenance condition. Unlike the peer group, the personalized approach focuses on multiple levels of community resources to promote healthful lifestyle change. Because this research focuses on issues of generalization and translation to practice, the RE-AIM evaluation framework is being used to evaluate Reach, Effectiveness, Adoption, Implementation and Maintenance. This framework will help to translate research into practice by directing researchers’ attention to important but seldom-investigated strategies for enhancing longer-term maintenance. Specifically, the study tests how long-term maintenance may be improved through the use of existing community resources, an intervention based on multiple environmental factors and multiple lifestyle behaviors, and lay leaders versus personalized professional support.

Enhancing support for health behavior change among women at risk for heart disease: the Mediterranean Lifestyle Trial