Lifestyle, Exercise and Nutrition Study 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, and serum hormones in breast cancer survivors.

Conditions

• Breast Cancer
• Weight Loss

Interventions

BEHAVIORAL

Weight Loss Counseling- Phone

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. During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.

BEHAVIORAL

Weight Loss Counseling- In-Person

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. During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change.

Sponsors & Collaborators

• Yale University

  lead OTHER

Principal Investigators

• Melinda L Irwin, PhD, MPH · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2014-01-31

Completion

2014-01-31

Countries

• United States

Study Locations