The Women's Healthy Lifestyle Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Motivational Interviewing for Weight Maintenance

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: motivational interviewing
* Behavioral: written materials only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The control arm receives written information and pedometers | Behavioral: written materials only<br>* dietary guidance materials and pedometers<br>|
| Experimental: 2<br>This arm also receives telephone counseling. | Behavioral: motivational interviewing<br>* telephone counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, exercise, diet, fruit, vegetables, low-fat