The Women's Healthy Lifestyle Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zora Djuric, University of Michigan
ClinicalTrials.gov Identifier:
NCT00583726
First received: December 20, 2007
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Motivational Interviewing for Weight Maintenance

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body fat [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2007
Study Completion Date: November 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The control arm receives written information and pedometers
Behavioral: written materials only
dietary guidance materials and pedometers
Experimental: 2
This arm also receives telephone counseling.
Behavioral: motivational interviewing
telephone counseling

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583726

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Zora Djuric, PhD University of Michigan
  More Information

Publications:
Responsible Party: Zora Djuric, Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00583726     History of Changes
Other Study ID Numbers: HUM00012524
Study First Received: December 20, 2007
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
chemotherapy
exercise
diet
fruit
vegetables
low-fat

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014