McCarroll 2014.

Study characteristics
Methods	Design: parallel design, 2‐arm, randomised controlled trial Setting: single‐centre study in Ohio, USA Used Case Comprehensive Cancer Center (affiliates University Hospitals Case Medical Center and Cleveland Clinic) tumor registry to identify participants. Letter was sent to potential participants describing the study and women were invited to attend an informational session. Follow‐up: 12 months. Outcome measures assessed at baseline, 3, 6 and 12 months.
Participants	Number of participants enroled 75 participants enroled; 41 in intervention arm and 34 in control arm Inclusion criteria Histologically confirmed endometrial cancer diagnosed within last 3 years Stage I or II Undergone surgical treatment of endometrial cancer in the form of total abdominal hysterectomy and bilateral salpingo‐oophorectomy with/without lymphadenectomy No evidence of disease at time of enrolment ECOG PS 0–2 BMI ≥ 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 6 months Baseline participant characteristics No differences in the baseline characteristics of participants between groups. Mean age 57 (SD 8.6) years in intervention arm, 58.9 (SD 10.9) in control arm. Overall, mean BMI 36.5 kg/m2; 36.4 kg/m2 (SD 5.5) in intervention arm and 36.5 kg/m2 (SD 9.6) in control arm. No ethnicity data were available. Comorbidities: hypertension in 31.7% and diabetes in 17.1% of intervention arm; hypertension in 35.3% and diabetes in 26.5% of control arm. All participants had an ECOG PS 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 16 group sessions focusing on diet and physical activity over 6 months and an additional 3 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 telephone, email and newsletters. Group topics included physical activity, nutrition and improving diet quality and behaviour modification designed to increase women's self‐efficacy. Sessions were 60 min with 8–10 women per group. Participants weighed in private at beginning of each session and weekly food/activity records reviewed. After 6 months when sessions ended, additional feedback and support was provided via newsletters, telephone and email. Topics included holiday recipes, reinforcement of goals for increasing calcium, decreasing sodium and ways to increase physical activity. Intervention followed a stepwise, phased approach using strategies outlined by social cognitive theory, indicating that the optimal intervention for a major behaviour change should focus on establishing short‐term goals, enabling the person to build self‐efficacy. Control arm Received "Healthy Eating & Physical Activity Across Your Lifespan, Better Health and You" 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.
Outcomes	Primary outcomes Overall survival: no deaths reported during 12‐month study 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 Recurrence‐free survival: not reported Cancer‐specific survival: no deaths reported during 12‐month study 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 at baseline, 3, 6 and 12 months. Power Power calculation performed and sufficient detail 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 2008).
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. Principal 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: principal investigator performed outcome assessments and was unblinded to treatment group allocation. This is unlikely to affect weight measurements but may impact upon QoL 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 study authors. Study was underpowered at 12 months to detect a weight loss of ≥ 4.0 kg in intervention arm. Quote: "Attrition in the trial overall was 21.3%. Six (14.6%) patients in the LI group (intervention) versus 10 (29.4%) in UC (control) 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 conducted according to intention‐to‐treat protocol; however, only 85.4% of participants in intervention arm and 70.6% of participants in control arm attended 12‐month assessments. Missing data were 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: "This research was supported by the American Cancer Society." Ethical approval: obtained Quote: "Institutional review board approval was granted …" Conflicts of interest: no significant conflicts of interest noted.