Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Michigan |
---|---|
Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00583726 |
This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.
Condition | Intervention |
---|---|
Breast Cancer |
Behavioral: motivational interviewing Behavioral: written materials only |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Motivational Interviewing for Weight Maintenance |
Estimated Enrollment: | 40 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
The control arm receives written information and pedometers
|
Behavioral: written materials only
dietary guidance materials and pedometers
|
2: Experimental
This arm also receives telephone counseling.
|
Behavioral: motivational interviewing
telephone counseling
|
Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet.
The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Zora Djuric, PhD | University of Michigan |
Responsible Party: | Unviesrity of Michigan ( Dr. Zora Djuric ) |
Study ID Numbers: | HUM00012524 |
Study First Received: | December 20, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00583726 History of Changes |
Health Authority: | United States: Institutional Review Board |
chemotherapy exercise diet |
fruit vegetables low-fat |
Body Weight Skin Diseases Breast Neoplasms Healthy Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |