Ligibel 2013.

Trial name or title	Healthy living after cancer: weight management pilot study
Methods	A 16‐week crossover randomised controlled trial
Participants	History of any malignancy and completed all adjuvant surgery, chemotherapy, and/or radiation at least 1 month before study enrolment (patients receiving ongoing hormonal or biologic therapy are eligible to participate). BMI > 25 kg/m² and ECOG performance status of 0 or 1. Physically able to exercise and physician consent to start a weight loss programme
Interventions	Immediate weight loss programme group: patients will also be provided with exercise and dietary goals to implement at home. The programme consists of 16 sessions focused on reducing calories and increasing exercise. Sample goals of the programme include reducing weight by 1 or 2 pounds per week and increasing exercise to at least 150 minutes of moderate exercise (such as walking) per week. Weight loss sessions will take place once per week for 16 weeks at Dana‐Farber. The participant will meet with a dietitian and an exercise specialist weekly during the sessions to set diet and exercise goals for the week. Each session will consist of discussion of a diet and/or exercise topic for 30 minutes and 30 minutes of group exercise. The participant will also be given a pedometer to help keep track of his/her exercise, a cookbook with low‐calorie recipes, and a journal to keep track of their exercise and the food eaten each day. The participant will bring the journal to each weight loss session to review with study staff Delayed Weight Loss Programme Group ‐ will take part in the weight loss intervention after the 16‐week control period
Outcomes	Weight, anthropometrics, QoL, physical activity, body image Assessment of outcomes will occur at baseline (pre‐randomisation), at the end of the 16‐week intervention or control period, and at 32 weeks
Starting date	October 2013
Contact information	Dr Jennifer Ligibel, Dana‐Farber Cancer Institute jligibel@partners.org
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