BACKGROUND: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors do not reach the recommended physical activity levels and have overweight. This has implications for both physical and psychological health, including an increased risk of subsequent and secondary cancers. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology in improving health outcomes in cancer survivors with overweight or obesity. Objective: This study aims to investigate whether a personalized mHealth behavior change intervention improves physical and psychological health outcomes in cancer survivors with overweight or obesity. METHODS: A sample of 123 cancer survivors (BMI >= 25 kg/m2) was randomly assigned to the standard care control (n = 61) or intervention (n = 62) condition. Group allocation was unblinded. The intervention group attended a 4-hour tailored lifestyle education and information session with physiotherapists, a dietician, and a clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through SMS text messaging contact with the research team). Direct measures of physical activity were collected using a Fitbit accelerometer. Data on anthropometric, functional exercise capacity, dietary behavior, and psychological measures were collected at face-to-face assessments in a single hospital site at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). RESULTS: The rate of attrition was 21% (13/61) for the control condition and 14% (9/62) for the intervention condition. Using intent-to-treat analysis, significant reductions in BMI (F[2,242] = 4.149; p = 0.02; etap2 = 0.033) and waist circumference (F[2,242] = 3.342; p = 0.04; etap2 = 0.027) were observed in the intervention group. Over the 24-week study, BMI was reduced by 0.52 in the intervention condition, relative to a non-significant reduction of 0.11 in the control arm. Waist circumference was reduced by 3.02 cm in the intervention condition relative to 1.82 cm in the control condition. Physical activity level was significantly higher in the intervention group on 8 of the 12 weeks of the intervention phase and on 5 of the 12 weeks of the follow-up period, accounting for up to 2500 additional steps per day (mean 2032, SD 270). CONCLUSIONS: The results demonstrate that for cancer survivors with a BMI >= 25 kg/m2, lifestyle education and personalized goal setting using mobile technology can yield significant changes in clinically relevant health indicators. Further research is needed to elucidate the mechanisms of behavior change and explore the capacity for mHealth interventions to improve broader health and well-being outcomes in the growing population of cancer survivors. TRIAL REGISTRATION: ISRCTN Registry ISRCTN18676721; https://www.isrctn.com/ISRCTN18676721

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