Spots Global Cancer Trial Database for Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
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Trial Identification
Brief Title: Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
Official Title: Lifestyle, Exercise and Nutrition (LEAN) Study 2
Study ID: NCT02110641
Interventions
Study Description
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, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.
Detailed Description: We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Yale University, New Haven, Connecticut, United States
Contact Details
Name: Melinda L Irwin, PhD, MPH
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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