Scott 2013.

Methods	Design: randomised controlled trial Country: UK Accrual dates: NR Trial Reg: ISRCTN08045231
Participants	Number randomised: 90 523 sent recruitment letter, 371 did not respond to letter, 86 enquiries from other sources, 238 total number of enquiries, 60 excluded, 64 refused to participate, 14 could not contact, 10 declined after familiarisation, 47 allocated to intervention group, 43 allocated to control, 6 lost to follow‐up intervention, 5 lost to follow‐up control, 41 completed 6‐month intervention assessments, 38 completed 6‐month control assessments Inclusion: overweight women with BMI 25 kg/m². Completed surgery, chemotherapy, and radiotherapy for early‐stage breast cancer (stage I to III) 3 to 18 months previously. Receiving adjuvant endocrine treatments and yet to complete a 1‐year course of adjuvant trastuzumab. Subject to acceptable cardiac function determined by a multi‐gated acquisition (MUGA) scan and consultant approval Exclusion: concomitant HRT or oral contraceptives; metastatic or active loco‐regional disease. Physical or psychiatric impairment limiting physical mobility. Severe nausea, anorexia, or other condition precluding participation in exercise. Following alternative/complementary diets. Taking high‐dose antioxidant supplements. Engaged in regular exercise Gender: female Age: Intervention: 55.6 mean (SD 10.2) years Control: 55.9 mean (SD 8.9) years Type of cancer: breast Therapy previously received for cancer: Mastectomy: intervention: n = 28 (60%), control: n = 9 (21%) Breast‐conserving surgery: intervention: n = 19, control: (40%) n = 34 (79%) Chemotherapy: intervention: n = 27 (57%), control: n = 23 (54%) Radiotherapy: intervention: n = 40 (85%), control: n = 35 (81%) Tamoxifen: intervention: n = 23 (49%), control: n = 22 (51%) Aromatase inhibitor: intervention: n = 14 (30%), control: n = 11 (26%) Trastuzumab: intervention: n = 4 (9%), control: n = 6 (14%) Lymphedema: intervention: n = 10 (21%), control: n = 15 (35%) Cancer stage: all early stage, I to III Ethnicity: white: intervention: n = 46 (98%), control: n = 42 (98%) Baseline physical activity: Resting heart rate, beats/min at baseline: intervention: 78 mean (SD 12), Control: 74 mean (SD 11) Education (SES): Secondary and A levels: intervention: n = 18 (38%), control: n = 12 (28%) Degree: intervention: n = 8 (17%), control: n = 8 (19%) Vocational qualifications: intervention n = 6 (13%), control: n = 2 (5%)
Interventions	Comparison: exercise and hypocaloric healthy eating programme vs control Intervention: 24‐week lifestyle intervention with 3 weekly supervised exercise sessions and an individually tailored hypocaloric healthy eating programme. Each participant also received one‐to‐one individualised dietary advice and written information (‘‘Weight Loss on a Plate,’’ Scottish Dietetic Association). Additional weekly small‐group nutrition education seminars included topics such as dietary fat intake, hydration, achieving a healthy balanced diet, and alcohol consumption Control: a healthy eating booklet, "Eat Well" (Food Standards Agency, UK), which also included brief advice on keeping active
Outcomes	Weight: measured by a standard technique BMI: measured by a standard technique Waist circumference: measured by a standard technique Waist‐ to‐hip ratio: measured by a standard technique % body fat: measured using bioelectrical impedance QoL: measured using the Functional Assessment of Cancer Therapy ‐ General (FACT‐G), including the breast subscale (FACT‐B) Dietary intake: measured using 3‐day diet diaries, which were analysed for total energy and macronutrient intake (NetWisp 3: Tinuviel Software Systems, Cheshire, UK) Duration of follow‐up: 6 months
Notes	Funding: American Institute for Cancer Research (Grant number 05A008‐REV)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomly allocated (1:1 ratio) to 1 of 2 groups: (1) lifestyle intervention group, or (2) control group. Randomisation was performed by an independent researcher at the Clinical Trials Research Unit, University of Leeds
Allocation concealment (selection bias)	Low risk	Randomisation sequence was not disclosed until patients had completed their baseline assessments
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	No blinding; outcome is not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	No blinding; outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	No blinding; outcome is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding of outcome assessment; outcome measurement is likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Objective	Low risk	Attrition 12%. Missing outcome data balanced in numbers across invention and control groups. ITT with missing data inputted
Incomplete outcome data (attrition bias) Subjective	Low risk	Attrition 12%. Missing outcome data balanced in numbers across invention and control groups. ITT with missing data inputted
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Unclear risk	Not reported