Lifestyle, Exercise and Nutrition (LEAN) Study 1
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index (BMI)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
In-Person Counseling
Participants randomized to in-person counseling will meet via in-person or via telephone (but at least 3 of the 11 sessions must be in person) weekly for month 1, then every other week for months 2, and 3, and then monthly for months 4-6 at Yale University. The meetings will last 30 minutes. Participants will turn in their diet and exercise logs and also be weighed. A lesson will then be discussed (see above for content).
Intervention: Weight Loss Counseling- In-Person (Behavioral)
Telephone-based Counseling
The exact same information, content, schedule, and 30 minute sessions will be provided to telephone-based participants as offered to participants who receive in-person counseling. Participants will be taught diet, exercise and behavior change strategies via the telephone (weekly calls for month 1, every other week for months 2-3, and monthly for months 4-6). All lessons and diet and physical activity logs will be mailed to them at the beginning of the program. Participants will record their daily diet and exercise in the logs. Every four weeks, participants will return, via stamped, addressed envelopes, the logs to the study office.
Intervention: Weight Loss Counseling- Phone (Behavioral)
Usual Care
Immediately after randomization, participants in the Usual Care Group will be provided written information that emphasizes the importance of a healthy lifestyle. Usual care participants will be encouraged to follow the American Cancer Society (ACS) nutrition and physical activity guidelines. Upon completion of the study (at 6 months), usual care participants will be offered all the educational material, as well as an in-person or telephone counseling session.
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)