Overview

This trial is active, not recruiting.

Conditions breast cancer, weight loss
Treatment weight loss counseling
Phase phase 3
Sponsor Yale University
Start date November 2013
End date November 2016
Trial size 100 participants
Trial identifier NCT02110641, 1012007780_1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
weight loss counseling
The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
(No Intervention)
At 6-months the participants in the Wait List group may choose to participate in the 11 sessions either in-person or via telephone or a combination of the two modes of delivery. They will also be offered the opportunity to return to Yale at 12-months (immediately after the end of the 6-month counseling sessions) to have weight and DEXA measured.

Primary Outcomes

Measure
Change in Body Mass Index (BMI)
time frame: 6 months
Change in body weight in kilograms (kg)
time frame: 6 months
Change in percent body fat
time frame: 6 months
Change in breast tissue markers
time frame: 6 months

Secondary Outcomes

Measure
Change in fasting insulin
time frame: 6 months
Change in Leptin
time frame: 6 months
Change in C-reactive protein
time frame: 6 months
Skin Carotenoids Assessment
time frame: 6 months
Maintenance of Weight Loss
time frame: 12 months
Changes in salivary cortisol
time frame: 6 months

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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: - Patients with double mastectomy

Additional Information

Official title Lifestyle, Exercise and Nutrition (LEAN) Study 2
Principal investigator Melinda L Irwin, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Yale University.