Lifestyle, Exercise and Nutrition (LEAN) Study 1
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Yale University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index (BMI)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Change in Body Mass Index (BMI)
Time Frame: 6 months
BMI will be calculated using weight and height measurements (weight (kg)/height (m)\^2 ). Weight and height will be measured by research staff blinded to the participant's randomization group at baseline and 6-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured in a standard manner, without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. All measures will be performed and recorded twice in succession.
Change in body weight in kilograms (kg)
Time Frame: 6 months
Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg. All measures will be performed and recorded twice in succession.
Change in percent body fat
Time Frame: 6 months
Dual Energy X-Ray Absorptiometry (DEXA) scans will be performed at baseline and 6-months. The DEXA measurements will be made with a Hologic scanner (Hologic 4500 with a "Discovery" upgrade, Hologic Inc, Waltham, Mass). A whole-body scan takes approximately 10 minutes to complete. Percent body fat will be measured utilizing DEXA.
Secondary Outcomes
- Change in fasting insulin(6 months)
- Change in Insulin-like growth factor 1 (IGF-1)(6 months)
- Change in Leptin(6 months)
- Change in C-reactive protein(6 months)
- Skin Carotenoids Assessment(6 months)
- Maintenance of Weight Loss(12 months)