Promoting weight loss through diet and exercise in overweight women with breast cancer

INTERVENTION: We will randomize overweight or obese patients into four intervention arms: 1. Dietary Intervention (DI) 2. Physical Activity Intervention (PAI) 3. Physical Activity And Dietary Intervention (PADI) 4. Less Intensive Intervention (LII) Women allocated to the dietary intervention and/or physical activity intervention arms will be offered an individualized dietary and/or physical activity counseling consisting of face‐to face contacts, group meetings, motivational phone calls and information pamphlets. All participants will be given a pedometer device (wrist band) in order to monitor (in the two physical activity arms) participants’ physical activity and sedentary time. Dietary intake for all participants will be repeatedly assessed with validated food frequency questionnaires. Quality of life, health status and participants' anxiety will be assessed with self‐administered questionnaires including FACT‐B and the State‐Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected at baseline and follow‐up visit to assess glucose, insulin, lipid and hormone profile. Women allocated to the less intensive intervention (or minimal counseling) arm will be considered as control group. Participants will be followed up for a further 18 months and outcome assessments will be made at 12 and 24 months. CONDITION: Overweight or obese breast cancer patients ; Cancer PRIMARY OUTCOME: Change in body weight (weight loss =5% of the baseline body weight) at the end of the 6‐month intervention SECONDARY OUTCOME: The secondary outcome measures will be assessed along intervention including:; 1. Maintain long‐term weight control, measured at baseline, 6 months, 12 months and 24 months; 2. Increase physical activity levels and reduce physical inactivity from baseline, measured at baseline, 6 months, 12 months and 24 months; 3. Change in dietary intake (increase adherence to healthy diet from baseline), measured at baseline, 6 months and 24 months; 4. Evaluate the effect of intervention on long‐term breast cancer recurrence; 5. Change in health status and quality of life, measured at baseline, 6 months, 12 months and 24 months; 6. Evaluate the effect of intervention on blood lipid profile (total cholesterol, LDL and HDL cholesterol, triglycerides), measured at baseline, 6 months and 24 months; 7. Evaluate the effect of intervention on biomarkers (estradiol, C‐reactive protein (CRP), insulin, glucose), measured at baseline, 6 months and 24 months INCLUSION CRITERIA: 1. Women aged 18 or older 2. Written informed consent obtained 3. Willing to be randomized to either group 4. Histological breast cancer diagnosis 5. BMI comprised between 25 and 40 kg/m2 6. Within one year/6 months of completion of main cancer treatment 7. Willing to wear the wrist‐based activity monitor during the 6‐month study period