Recruitment

Recruitment Status
Completed

Inclusion Criteria

Mentally competent
Physically able to exercise
Gives informed consent to participate in all study activities
...
Mentally competent
Physically able to exercise
Gives informed consent to participate in all study activities
American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
Completed surgery, chemotherapy and radiation at least 2 months ago
Able to come for baseline and 6-month clinic visits
Agrees to be randomly assigned to either weight loss or control
BMI >25 kg/m2

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

Mentally competent
Physically able to exercise
Gives informed consent to participate in all study activities
...
Mentally competent
Physically able to exercise
Gives informed consent to participate in all study activities
American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
Completed surgery, chemotherapy and radiation at least 2 months ago
Able to come for baseline and 6-month clinic visits
Agrees to be randomly assigned to either weight loss or control
BMI >25 kg/m2

Tracking Information

NCT #
NCT02109068
Collaborators
Not Provided
Investigators
  • Principal Investigator: Melinda L Irwin, PhD, MPH Yale University
  • Melinda L Irwin, PhD, MPH Yale University