A RANDOMIZED STUDY EVALUATING THE EFFECT OF A REMOTE-BASED WEIGHT LOSS PROGRAM (POWER-REMOTE) ON BIOMARKERS IN WOMEN WITH EARLY STAGE BREAST CANCER
Researchers have developed a weight loss program, called POWER, that was tested in a general population and shown to be an effective and easy to access weight loss intervention. Eligible participants are randomly assigned to one of two study groups: 1)dietary intervention group (POWER-remote) 2)no intervention group (Self-directed). The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program by comparing the patterns in blood and breast tissue samples, and questionnaires evaluating different aspects of one's well-being, before and after a dietary intervention vs no intervention.
- women, 18 years or older- early stage breast cancer, having completed surgery and radiation therapy, chemotherapy at least 3 months, and not more than 36 months ago- overweight with a weight of no more than 400 pounds and a current BMI (body mass index) of 25 or higher, and willing to lose at least 5% of body weight- comfortable using and have access to the internet and a phone, and have an email address- not currently in a weight loss program or taking weight loss medications, or have a history of bariatric surgery- not pregnant or nursing
Participants in both groups will have baseline and follow-up visits at 6 and 12 months which will include questionnaires and blood draws for research samples Some participants may also be asked to provide an optional breast fine needle aspiration (FNA). Participants in the POWER-remote group will also be asked to participate in phone calls over one year with a weight loss coach and use an interactive website that includes weight loss tools and materials.
03/13/2014 04:02 AM