Lifestyle, Exercise and Nutrition Study 1
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Completed surgery, chemotherapy and radiation at least 2 months ago
- 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
- American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
- BMI >25 kg/m2
- Agrees to be randomly assigned to either weight loss or control
- Gives informed consent to participate in all study activities
- Mentally competent
- Physically able to exercise
- Able to come for baseline and 6-month clinic visits
Summary
- Conditions
- Breast Cancer
- Weight Loss
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Only females
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 counseli...
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.
Inclusion Criteria
- Completed surgery, chemotherapy and radiation at least 2 months ago
- 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
- American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
- BMI >25 kg/m2
- Agrees to be randomly assigned to either weight loss or control
- Gives informed consent to participate in all study activities
- Mentally competent
- Physically able to exercise
- Able to come for baseline and 6-month clinic visits
Tracking Information
- NCT #
- NCT02109068
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Melinda L Irwin, PhD, MPH Yale University
- Melinda L Irwin, PhD, MPH Yale University
Get Well Soon