Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors

Study Overview
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Brief Summary
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RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight. PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors.

Detailed Description
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OBJECTIVES: To develop a weight loss intervention for obese African American women who are breast cancer survivors. OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups. Group 1: Participants receive traditional individual dietary and exercise counseling in combination with the Weight Watchers weight loss program for 18 months. Group 2: Participants receive individual dietary and exercise counseling in combination with the Weight Watchers weight loss program as in group 1. They also receive spiritual counseling that incorporates meditation, readings, and the recording of thoughts into a long-term weight management program. The program addresses coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.

Official Title
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A Culturally-Tailored Weight Loss Program

Conditions
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Breast Cancer, Obesity, Weight Changes

Intervention / Treatment
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* Behavioral: Diet
* Other: Spiritual counseling


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer within the past 5 years Stage I-IIIA disease No recurrence of cancer Identified as African American Body Mass Index 30-40 Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Stable body weight Not currently following a special diet No uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling PRIOR CONCURRENT THERAPY: More than 3 months since prior chemotherapy or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dietitian-led counseling and Weight Watchers<br>Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter. | Behavioral: Diet<br>* Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.<br>|
| Dietitian & Weight Watchers + Spirituality Counseling<br>Dietitian wkly for the 1st-3 months, every other week for the next 3 months and monthly thereafter; Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter. | Behavioral: Diet<br>* Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.<br>Other: Spiritual counseling<br>* Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight changes, obesity, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer