McCarroll 2014.

Methods	Design Comment: Parallel design, two‐arm, randomised controlled trial Quote: "...two‐group randomised trial...Patients were randomised to either: 1) a lifestyle intervention (SUCCEED) group that received nutrition, exercise, and behavioral modification counselling and 2) a usual care (UC) group..." Setting Comment: Single‐centre study in Ohio, USA Quote: "The Case Comprehensive Cancer Center (affiliates University Hospitals Case Medical Center and Cleveland Clinic) tumor registry was used to identify potential subjects. A letter was sent to potential patients describing the study and women were invited to attend an informational session." Follow‐up Comment: 12 months Quote: "Outcome measures were assessed in both groups at baseline, 3, 6, and 12 months."
Participants	Number of participants enrolled 75 participants enrolled; 41 in the intervention arm and 34 in the control arm Inclusion criteria Histologically‐confirmed endometrial cancer diagnosed within last three years Stage I or II Undergone surgical treatment of endometrial cancer in the form of total abdominal hysterectomy and bilateral salpingo‐oophorectomy +/‐ lymphadenectomy No evidence of disease at time of enrolment Performance status 0‐2 BMI greater than or equal to 25 kg/m2 Medical clearance from primary care physician and approval to contact patient by treating gynae‐oncologist Exclusion criteria Unable to read consent form Severe depression, dementia or cognitive deficit Unavailable for longitudinal follow‐up assessment Pre‐existing medical conditions that prevent participation in unsupervised walking Participation in weight‐loss or exercise programme in preceding six months Baseline participant characteristics There were no significant differences in the baseline characteristics of participants between the two groups. The mean age of participants in the intervention arm was 57 years (SD 8.6 years) compared with 58.9 years (SD 10.9 years) in the control arm. Overall, the mean BMI was 36.5 kg/m2; 36.4 kg/m2 (SD 5.5) in the intervention arm and 36.5 kg/m2 (SD 9.6) in the control arm. The co‐morbidities hypertension and diabetes were present in 31.7% and 17.1% of participants in the intervention arm compared with 35.3% and 26.5% of participants in the control arm, respectively. All participants had a performance status of 0‐2. All participants underwent surgical treatment of their endometrial cancer, on average, 20.7 months earlier. In addition, 39.0% of participants in the intervention arm and 35.3% of participants in the control arm had undergone adjuvant radiotherapy. Details of grade, stage and histological type of endometrial cancer were not provided.
Interventions	Intervention arm Comment: Sixteen group sessions focusing on diet and physical activity over six months and an additional three face‐to‐face counselling visits at 3, 6 and 12 months. Feedback and support were provided by a registered dietitian after the end of the group sessions by phone, email and newsletters. Quote: "Sixteen group sessions were conducted (10 weekly followed by 6 bi‐weekly) in the SUCCEED group. Physician face‐to‐face counselling visits occurred at 3, 6 and 12 months. Group topics included PA, nutrition and improving diet quality and behavior modification designed to increase women's self‐efficacy. Sessions were 60 min in length with 8–10 women per group. The RD weighed participants in private at the beginning of each session and weekly food/activity records were reviewed. After 6 months when the group sessions ended, additional feedback and support was provided by the RD via newsletters, telephone and email. Newsletter topics included holiday recipes, reinforcement of goals for increasing calcium, decreasing sodium, and ways to increase PA. The intervention followed a stepwise, phased approach using strategies outlined by social cognitive theory, indicating that the optimal intervention for a major behavior change should focus on establishing short‐term goals, enabling the person to build self‐efficacy." Control arm Comment: Received information brochure only. Participants also attended physician counselling sessions at 3, 6 and 12 months, but these visits did not include any lifestyle advice related to weight loss, physical activity or nutrition. Quote: "Patients randomized to the (control) group received an informational brochure (“Healthy Eating & Physical Activity Across Your Lifespan, Better Health and You”).
Outcomes	Primary outcomes Overall survival: No deaths reported for the duration of the study period (12 months) Adverse events: Reported adverse events in both intervention and control arms Quote:"(Adverse events were reported) as required by the IRB...The true adverse events were all in the intervention group" Second outcomes Recurence‐free survival: Not reported Cancer‐specific survival: No deaths reported for the duration of the study period (12 months) Weight loss: Weight change from baseline at 3, 6 and 12 months reported Cardiovascular and metabolic event frequency: No events reported QoL: Change in QoL from baseline measured at 3, 6 and 12 months using FACT‐G questionnaire Quote: "Quality of life (QoL) was measured by the Functional Assessment of Cancer Therapy—General (FACT‐G)... FACT‐G was measured at baseline, 3, 6, and 12 months post‐baseline." Power Comment: A power calculation was performed and sufficient detail was provided to allow it to be replicated Quote: "Approximately 37 patients per group were needed to provide 80% power to detect a difference between groups in mean weight change from baseline to 12 months of 4.0 kg or greater (alpha= 0.05, two‐sided, SD= 6.0; effect size= 0.67) and to assess changes in PA with a similar effect size. Effect sizes of 0.5 are considered medium and 0.8 or greater large."
Notes	This is the definitive RCT following on from the pilot study also included in this review (von Gruenigen 2009)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: Block randomisation performed according to baseline BMI Quote: "Randomization was stratified using block sizes of 6 or 8 by baseline BMI (25.0–39.9 versus > 40)"
Allocation concealment (selection bias)	Unclear risk	Comment:No details of allocation concealment provided by study authors
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel not possible due to nature of intervention. Principle investigator involved in delivery of intervention so aware of randomisation. Quote: "Due to the interventions performed by the study team (dietitian, Physical therapist, psychologist, etc.), they were able to know who was in each group."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Principle investigator performed outcome assessments and was unblinded to treatment group allocation. This is unlikely to affect weight measurements but may impact upon quality of life assessments
Incomplete outcome data (attrition bias) All outcomes	High risk	Follow‐up Entered into the study: 41 in intervention arm and 34 in control arm Withdrew from study: 6 in intervention arm and 10 in control arm Completed study: 35 in intervention arm and 24 in control arm Reasons for withdrawal from study not provided by authors. The study was underpowered at 12 months to detect a weight loss of 4.0 kg or greater in the intervention arm. Quote: "Attrition in the trial overall was 21.3%. Six (14.6%) patients in the LI group versus 10 (29.4%) in UC did not complete the twelve‐month assessments, P = 0.159. Thirty‐one (75.6%) participants in the (intervention arm) attended 14 or more of the 16 sessions; mean adherence was 84.1%. Intention‐to‐treat analysis Comment: Analyses were conducted according to an intention‐to‐treat protocol, however, only 85.4% of participants in the intervention arm and 70.6% of participants in the control arm attended for the 12 month assessments. Missing data were imputed by multiple imputation. Quote: "Analyses were done according to intention‐to‐treat principles. Missing data were examined and imputed by multiple imputation"
Selective reporting (reporting bias)	Low risk	Comment: Protocol not published but trial registered prospectively on clinicaltrials.gov and all prespecified outcomes reported
Other bias	Low risk	Source of funding Comment: Source of funding described Quote:"This research was supported by the American Cancer Society." Ethical approval Comment: Ethical approval was obtained Quote: "Institutional review board approval was granted..." Conflicts of interest Comment: No significant conflicts of interest noted