Allison 2016.

Methods	Design Comment: Parallel design, 3‐arm, open‐label randomised controlled trial Quote: "..randomised, controlled study..." Setting Comment: Multicentre study in USA. Quote: "...multi‐site, pilot feasibility study..." Follow‐up Duration: 6 months Quote: "...6 month follow‐up..."
Participants	Number of participants enrolled 41 women were randomised; 13 into Arm A, 13 into Arm B and 15 into Arm C. Six‐month follow‐up data were only available for 30 women at the time of undertaking this review (11 Arm A, 10 Arm B, 9 Arm C) Inclusion criteria Women aged 18 years or older Biopsy proven endometrial cancer of any histological type BMI greater than or equal to 30 kg/m2 ECOG PS 0‐1 No concurrent or planned chemo‐radiation Access to wireless Internet and/or smartphone Life expectancy > 1 year Exclusion criteria Significant medical condition that would affect compliance with protocol or ability to participate, e.g. uncontrolled hypertension, symptomatic cardiac disease Current participation in another weight‐loss programme or taking weight‐loss medication Another invasive malignancy in last five years (excluding non‐melanoma skin cancer) Autoimmune or immunosuppressive condition Currenty taking immunosuppressant medication Currently pregnant Baseline participant characteristics The mean age of participants was 62.2 years (SD 8.7 years), with a mean BMI of 39.1 kg/m2 (range 30 kg/m2 to 67 kg/m2). Details of co‐morbid conditions not collected by study authors. Participants had both type I and type II endometrial cancer, though the grade and stage of their malignancy was not provided. All had ECOG PS 0‐1 and had undergone surgical treatment of their endometrial cancer. Baseline characteristics of participants according to group allocation were not provided.
Interventions	Arm A Comment: Telemedicine arm. Telephone‐based weight‐loss counselling undertaken by trained interventionists with guided digital measurements of weight, lean and fat mass. Counselling and weight‐loss measurements occurred at least weekly for the six months duration of the intervention. Quote: "The telemedicine arm included a Wifi scale that recorded at least weekly weights of participants. The scale automatically graphs the weights on a password protected website which permitted counsellors to have immediate feedback during weekly 15‐20 minute counselling sessions teach standard weight‐loss skills, including self‐monitoring, problem‐solving, enlisting social support, and overcoming negative thoughts according to a standard curriculum." Arm B Comment: Text4Diet Group. Participants received 3‐5 Short Message Service (SMS) text messages each day for the six‐month intervention period. The text message provided tips and reminders to encourage healthy eating and weight loss. Participants also received a digital scale to track and report weight and were prompted to do so once a week by text message. Quote: "The texting arm receives personalized text messages daily, following different monthly themes, e.g. Do not go to a party hungry. Eat a healthy snack before or bring a healthy dish with you to share. You will be more likely to stick to your goals! Since you have been meal planning do you find that you eat out less often? Y or N‐remember the restaurant website is a great way to help you plan a healthy meal to order. Different styles included encouraging statements, yes/no questions or multiple choice questions." All participants in Arms A and B recorded dietary intake and restricted calories to 1200 kcal/day to 1500 kcal/day. They were given an exercise goal of 50 minutes/week to 175 minutes/week of moderate, aerobic physical activity, e.g. brisk walking. Arm C Comment: Enhanced Usual Care Group. Participants provided with handouts based on American Cancer Society guidelines on healthy eating and exercise and did not receive any additional input from the research team. Quote:"...printed information from American Cancer Society guidelines on healthy eating and exercise...encourage weight loss through dietary monitoring and a walking program...these efforts were not reinforced or monitored by study staff..."
Outcomes	Primary outcomes Overall survival: No deaths were reported in any arm for the duration of the study. Adverse events: Not reported Second outcomes Recurence‐free survival: Not reported Cancer‐specific survival: No cancer‐specific deaths were reported in any arm for the duration of the study Weight loss: Change in weight from baseline at 6 months reported Cardiovascular and metabolic event frequency: No events reported in any arm QoL: Change in QoL from baseline at 6 months reported using SF‐12 Physical Health component change score Quote: "Change in quality of life from baseline... SF‐12 Physical Health component change score" Power Comment: No power calculation performed. Aim of study was to provide estimates of the effect size of the intervention in order to power a full‐scale trial Quote: "The purpose will be to provide estimates for the size of an intervention effect achievable by the experimental intervention in order to power and justify a grant application for a full‐scale trial of a weight loss program in women with endometrial cancer. With a sample size of 30 participants per group, the true difference in mean weight loss between the groups can be estimated with a 95% confidence interval size of ±0.50σ, where σ is the population standard deviation of weight loss, assumed in this calculation to be the same in each of the two intervention groups and the control group. We will assess the comparability of variance across the groups and do exploratory analyses of possibly variance‐stabilizing transformations. Because this is a pilot study to derive parameters to design an appropriately‐powered study, hypothesis testing is not a primary goal of the statistical analysis of the data, although P‐values will be calculated."
Notes	Study not yet published. Information obtained through correspondence with research team.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: Computer‐generated algorithm used at co‐ordinating centre to produce randomisation envelopes for each site. Quote: "The coordinating center used a computer generated algorithm to produce the randomization envelopes for each clinical site, with the general parameters of randomizing 1:1:1 across the three conditions."
Allocation concealment (selection bias)	Low risk	Comment: Next envelope chosen for each enrolled participant Quote: " The envelopes are then chosen sequentially as each participant was enrolled."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Participants and personnel were unblinded Quote: "There was no blinding."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Outcome assessments performed by unblinded study co‐ordinators Quote: "The outcome assessments were conducted by study coordinators and trained medical personnel (for blood draws, DEXA). The coordinators knew which condition the participants were in, but other medical personnel were not informed."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up Entered the study: 13 into Arm A , 13 into Arm B and 15 into Arm C Withdrew from study: 0 in Arm A, 0 in Arm B, 0 in Arm C Completed the study (at the time of correspondence): 11 in Arm A, 10 in Arm B, 9 in Arm C No missing data reported. Intention‐to‐treat analysis Comment: Not performed Quote: "Given we only had pre‐post assessment data and our main analyses used paired t‐tests and correlations, we were unable to do intention‐to treat analyses."
Selective reporting (reporting bias)	Low risk	Comment: Protocol not published but trial registered prospectively on clinicaltrials.gov and all prespecified outcomes reported
Other bias	Unclear risk	Source of funding Comment: Source of funding described Quote: "Cross‐TREC study funded by NCI U54‐CA155850 – University of Pennsylvania; U54 CA155626 – Harvard University; U54 CA155496CC – Washington University; U01 CA116850 – Fred Hutchinson Cancer Research Center." Ethical approval Comment: Ethical approval obtained Conflicts of interest Comment: No conflicts of interest reported Other sources The study failed to enrol 30 participants into each group within their allotted time. The reasons for this were not provided. Four centres open to recruitment although only the UniversitIes of Washington and Pennsylvania enrolled patients into the study. Only 30 participants had completed 6 months of follow‐up at the time of correspondence with the study's chief investigator. Further results will be available for inclusion when the review is updated.