Limited evidence exists on the effects of weight loss on chronic disease risk and patientreported outcomes in breast cancer survivors. Breast cancer survivors (stage I to III; body mass index 25 to 45 kg/m2) were randomized to a 12-month, remotely delivered (22 telephone calls, mailed material, optional text messages) weight loss (diet and physical activity) intervention (n = 79) or usual care (n = 80). Weight loss (primary outcome), body composition, metabolic syndrome risk score and components, quality of life, fatigue, musculoskeletal pain, menopausal symptoms, fear of recurrence, and body image were assessed at baseline, 6 months, 12 months (primary endpoint), and 18 months. Participants were 55 +/- 9 years and 10.7 +/- 5.0 months post-diagnosis; retention was 81.8% (12 months) and 80.5% (18 months). At 12-months, intervention participants had significantly greater improvements in weight (-4.5% (95%CI -6.5 to -2.5); p < 0.001), fat mass (-3.3 kg (-4.8 to -1.9); p < 0.001), metabolic syndrome risk score (-0.19 (-0.32 to -0.05); p = 0.006), waist circumference (-3.2 cm (-5.5 to -0.9); p = 0.007), fasting plasma glucose (-0.23 mmol/L (-0.44 to -0.02); p = 0.032), physical quality of life (2.7 (0.7 to 4.6); p = 0.007; Cohen's effect size (d) = 0.40), musculoskeletal pain (-0.5 (-0.8 to -0.2); p = 0.003; d = 0.49), and body image (-0.2 (-0.4 to -0.0); p = 0.030; d = 0.31) than usual care. At 18 months, effects on weight, adiposity, and metabolic syndrome risk scores were sustained; however, significant reductions in lean mass were observed (-1.1 kg (-1.7 to -0.4); p < 0.001). This intervention led to sustained improvements in adiposity and metabolic syndrome risk.

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