Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-26 @ 9:55 AM
Study NCT ID:
NCT02109068
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle, Exercise and Nutrition Study 1
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Lifestyle, Exercise and Nutrition (LEAN) Study 1
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEAN
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: