Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer

Summary

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PRIMARY OBJECTIVES: I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus [vs.] control) improves serum fasting glucose. II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of glucose regulation (insulin, C-peptide, insulin-lik...

PRIMARY OBJECTIVES: I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus [vs.] control) improves serum fasting glucose. II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of glucose regulation (insulin, C-peptide, insulin-like growth factor-1 [IGF-1], IGF binding protein 3 [IGF-BP3] and adiponectin). III. To test whether the DPP lifestyle intervention decreases the levels of insulin receptor or insulin-like growth factor-1 receptor (IGF-1R) in prostate cancer (PCa) tissue epithelium on follow-up prostate biopsy. IV. To test whether PCa patients randomized to the DPP lifestyle intervention sustain the lifestyle changes for at least 6 months after the end of the intervention period. SECONDARY OBJECTIVES: I. To evaluate whether the DPP lifestyle intervention improves health-related quality of life. II. To evaluate whether the DPP lifestyle intervention effects on pathologic features of follow-up prostate biopsies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study. ARM II: Patients receive oral and written information based on general U.S. dietary and physical activity guidelines along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week. After completion of study, patients are followed up at 3, 6, and 12 months.

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