NCT02037542

A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Weight

Interventions

Type	Name	Description
BEHAVIORAL	Diet and exercise	Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-01-16
• Last updated: 2016-07-21

Locations

1 site across 1 country: United States