Lifestyle, Exercise and Nutrition Study 1

Lifestyle, Exercise and Nutrition (LEAN) Study 1

The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

Proposed is a three-arm randomized controlled trial of 6-months of weight loss counseling (i.e., dietary-induced caloric restriction and physical activity) on clinically meaningful endpoints in 100 breast cancer survivors . The three arms will be: 1. In-person counseling, 2. Telephone-based counseling, 3. Usual care. Women will be randomized into one of 3 study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Inclusion Criteria:

• American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
• BMI >25 kg/m2
• Completed surgery, chemotherapy and radiation at least 2 months ago
• Physically able to exercise
• Agrees to be randomly assigned to either weight loss or control
• Gives informed consent to participate in all study activities
• Able to come for baseline and 6-month clinic visits
• Mentally competent

Exclusion Criteria:

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