High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women

All subjects participate in same intervention. Intervention consists of a 6-month structured
weight loss program utilizing portion controlled meals and a prescribed level of graduated
physical activity with an eventual goal of 200 minutes or more per week. The program will
include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions
the first 3 months with transition to unsupervised exercise and less frequent group phone
sessions the second 3 months.

Inclusion Criteria:

- Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or
surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of
breast cancer but at high risk for development of breast cancer and participating in
HSC 4601 (Cohort B)

- Body Mass Index (BMI) >30 kg/m2. Women with a BMI > 45 kg/m2 must be age < 60 and
ability to perform physical activity must be confirmed

- By self-assessment, currently performing 60 minutes or less of purposeful exercise per
week but able to walk at least 30 minutes on a level surface

- Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and
willing to have diet and exercise data accessed by study personnel

- Access to a personal computer

- Live in the greater Kansas City Metropolitan Area

- Willing and able to perform moderate intensity exercise at least 5 days per week for 6
months. This consists of a supervised exercise intervention at one of the 15 YMCAs
affiliated with our program for 2 days per week. Must be willing to perform
unsupervised home exercise for the entire 6 months.

- Willing to participate in a weekly behavioral modification group phone call for first
3 months and every 2 weeks for the second 3 months

- Willing to participate in a controlled dietary intervention with portion controlled
meals and partial meal replacements plus 35 servings of fruits and vegetables/week for
6 months and track food intake and exercise

- Blood tests (Cohort A2) must have been performed after completion of any breast cancer
surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver
and renal function as well as a hemoglobin of 10 or higher and/or performed within a
year of study entry

Exclusion Criteria:

- Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic
drugs within the prior 3 weeks

- Individuals with prior gastric bypass surgery or procedure that would impair
absorption of nutrients

- Need for chronic immunosuppressive drugs

- Participation within the past 6 months on a structured weight loss program such as
Weight Watchers®

- Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit
performing moderate intensity exercise at least 5 days per week.

- Any other condition or intercurrent illness that in the opinion of the investigator
makes the subject a poor candidate for participation in the trial such as recent
cardiac event

- Currently receiving investigational agents in a clinical trial