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Brief Title: A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Official Title: A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Study ID: NCT02037542
Brief Summary: The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
Detailed Description: * Primary endpoint: To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study. * Secondary endpoint: To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention * Secondary endpoint: To examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
South Miami Hospital, Miami, Florida, United States
Name: Maria Amelia Rodrigues, MD
Affiliation: BHSF
Role: PRINCIPAL_INVESTIGATOR