Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): A randomized controlled trial

Objective. The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle. Methods. Early stage overweight and obese (body mass index >= 25) ECS (N = 75) were randomized to a 6-month lifestyle intervention (LI) or usual care (UC). The LI group received education and counseling for six months (10 weekly followed by 6 bi-weekly sessions). Weight change at 12 months was the primary endpoint. Secondary outcomes included fruit/vegetable servings/day and physical activity (PA). Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline. Results. Adherence was 84% and follow-up data were available from 92% of participants at 6 months and 79% at 12 months. Mean [95% CI] difference in weight change between LI and UC groups at 6 months was -4.4 kg [-5.3, -3.5], p<0.001 and at 12 months was -4.6 kg [-5.8, -3.5], p<0.001. Mean [95% Cl] difference in PA minutes between groups at 6 months was 100[6, 194], p = 0.038 and at 12 months was 89[14, 163], p = 0.020. Mean difference in kilocalories consumed was -217.8 (p<0.001) at 6 months and -187.2 (p<0.001) at 12 months. Mean [95% CI] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months (p<0.001). Conclusions. Behavior change and weight loss are achievable in overweight and obese ECS, however, the clinical implications of these changes are unknown and require a larger trial with longer follow-up. (C) 2012 Elsevier Inc. All rights reserved.