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Reducing Breast Cancer Recurrence With Weight Loss

NCT01112839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2015-06-18

No results posted yet for this study

Summary

The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.

Conditions

Interventions

BEHAVIORAL

Less Intensive

Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.

BEHAVIORAL

Intensive Group

Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Cheryl L. Rock, PhD, RD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01112839 on ClinicalTrials.gov