The Women's Healthy Lifestyle Study

Breast Cancer Clinical Trial

Official title:

Motivational Interviewing for Weight Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583726
• Other study ID #: HUM00012524
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: November 30, 2015
• Start date: December 2007
• Est. completion date: November 2011

Study information

• Verified date: December 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult female, age 18 and older

• Stage I, II, or IIIA breast cancer

• Scheduled for chemotherapy and completed no more than two weeks of chemotherapy

• Body mass index 25-45 kg/m2

• Stable body weight within 5 pounds in the past 2 months

• Physician approval for participating in a weight control program

• Willing and able to follow advice for exercise and diet quality

Exclusion Criteria:

• Previous invasive cancers, excluding basal cell carcinoma, in the past 10 years

• Following a medically-prescribed diet

• Currently participating in a formal weight loss program

• Medical conditions that preclude safe exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• motivational interviewing
telephone counseling
• written materials only
dietary guidance materials and pedometers

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

Djuric Z, Ellsworth JS, Weldon AL, Ren J, Richardson CR, Resnicow K, Newman LA, Hayes DF, Sen A. A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Open Obes J. 2011;3:87-97. — View Citation

Djuric Z, Ren J, Brown PR, Ellsworth JS, Sen A. Lifestyle factors associated with serum N-3 fatty acid levels in breast cancer patients. Breast. 2012 Aug;21(4):608-11. doi: 10.1016/j.breast.2012.02.003. Epub 2012 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		12 months	No
Secondary	Change in body fat		12 months	No