Mediterranean Lifestyle Project

Deborah J. Toobert, Ph.D. Oregon Research Institute

Abstract:

Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This proposal addresses the poorly understood “natural history” of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The proposed study is a continuation of a current research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors in a sample of postmenopausal women with type 2 diabetes. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories. For the current study, 279 postmenopausal women having type 2 diabetes were recruited and randomized into two groups: (1) usual care (assessment only) and (2) the Mediterranean Lifestyle Program (MLP), a comprehensive lifestyle change intervention. The MLP yielded significant behavioral, psychosocial, and physiologic outcomes at 6 and 12 months post-intervention. In the proposed assessment-only “natural history” continuation, the longer-term (3- to 7-year) effects of the MLP will be examined using a variety of statistical approaches, including state-of-the-art mediational and latent growth modeling techniques. In addition, the potential for translating this program into the real world will be assessed using the RE-AIM evaluation framework, a cost-effectiveness analysis will be conducted, and dissemination of the intervention will begin if it proves cost-effective. This proposal represents the next logical step in this line of research, as it examines long-term maintenance of behavior change and lays the groundwork for translation of this successful intervention into practice. It will also provide important scientific and theoretical information about the patterns of maintenance/relapse among multiple risk factors, and about the relative importance of theoretical mediating variables (self-efficacy; problem-solving; peer and community support).

Specific Aims:

The primary goals of this project are to examine long-term maintenance of behavior change on multiple risk factors and to lay the groundwork for translating a successful lifestyle change intervention into practice. The proposed study is a continuation of an existing research project focused on postmenopausal women with type 2 diabetes, who are at high risk for developing coronary heart disease (CHD). In the current study, a theory-based comprehensive lifestyle change program (Mediterranean Lifestyle Program [MLP]) was shown to be effective in improving behavioral, psychosocial, quality of life, and physiologic outcomes. In the continuation, longer-term (3- to 7-year) effects of the MLP relative to usual care (UC) will be examined. In addition, the potential for translating the MLP into practice will be evaluated, the theoretical mechanisms of behavior change will be explored, cost-effectiveness analysis will be conducted, and a dissemination plan will be developed. More specifically, the aims of the project are to:

  1. Assess the longer-term (3- to 7-year) maintenance of multiple behavior changes (dietary, physical activity, and stress management), psychosocial factors (self-efficacy, problem-solving skills, social support, depression, stress), physiologic outcomes (body weight and composition, lipids and lipoproteins, HbA1c, progression of atherosclerosis), and quality of life indicators in the MLP group compared to the UC group.

  2. Determine, using mediation analysis, structural equation modeling, and latent growth modeling, the patterns and theoretical mechanisms of relapse and maintenance by evaluating the effects of hypothesized mediators (e.g., problem-solving skills, depression, stress, self-efficacy, and utilization of community support resources) on primary outcomes.

  3. Use the RE-AIM evaluation framework to assess the potential for translation of the MLP into clinical and managed care settings. The program will be evaluated on its Reach; Effectiveness across participants, settings, and intervention agents; Adoption; Implementation; and Maintenance.

  4. Estimate the replication costs, cost-effectiveness, and other economic outcomes of the MLP.

  5. Develop a comprehensive plan and begin to disseminate the intervention if it proves cost-effective in producing long-term improvements.