Irwin 2014.

Trial name or title	Lifestyle, exercise, and nutrition study 2 (LEAN 2)
Methods	A parallel randomised controlled trial
Participants	Those with a diagnosis of breast cancer ‐ American Joint Committee on Cancer (AJCC) stages 0 to IIIC, with BMI > 25 kg/m² Completed surgery, chemotherapy, and radiation at least 2 months ago and physically able to exercise
Interventions	Intervention arm: intervention will be based on the Diabetes Prevention Program weight loss programme, which uses a combination of reduced caloric intake, increased physical activity, and behaviour therapy. Content of the weight loss programme will be similar for the in‐person and telephone interventions, but the approach will vary (i.e. in‐person vs telephone counselling). Participants will be taught diet, exercise, and behaviour change strategies via the telephone (weekly calls for month 1, every other week for months 2 and 3, and monthly for months 4 to 6). All lessons and diet and physical activity logs will be mailed to participants at the beginning of the programme. Participants will record their daily diet and exercise in the logs Control arm: usual care/wait‐list ‐ at 6 months, participants in the wait‐list group may choose to participate in the 11 sessions either in‐person or via telephone or a combination of the two modes of delivery. They will also be offered the opportunity to return to Yale at 12 months (immediately after the end of the 6‐month counselling sessions) to have weight and DEXA measured
Outcomes	BMI, weight, height, body fat percentage, hormones, physical activity, dietary intake All outcomes are measured at baseline and at 6 months
Starting date	April 2014
Contact information	Dr Melinda L Irwin, Yale University, USA 203 785 6392 Melinda.irwin@yale.edu
Notes