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Clinical Trial: Weight Loss Counseling for African American Breast Cancer Survivors
This study is not yet open for patient recruitment.
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Purpose
The purpose of this study is to develop a weight loss intervention for obese African American breast cancer survivors.
| Condition | Treatment or Intervention |
|---|---|
| Obesity Breast Neoplasms | Behavior: Spirituality Counseling for Weight Management |
MedlinePlus related topics: Breast Cancer; Obesity
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Culturally-Tailored Weight Loss Program
Expected Total Enrollment: 50
Study start: May 2004; Expected completion: April 2006
The impact of obesity on insulin resistance and breast cancer prognosis is a matter of major concern for African American breast cancer survivors, who have higher rates of obesity, insulin-resistance, and diabetes than European Americans. Because weight loss requires a lifestyle change, weight loss counseling that incorporates spirituality may be particularly effective in African American women, who are more likely than European Americans to use spiritual influences in their lives.
Participants in this study will be randomly assigned to receive 18 months of either traditional or spiritualized individual dietary and exercise counseling in combination with the Weight Watchers weight loss program. The spiritual counseling will use an 8-component theoretical framework that will include meditation, readings, and the recording of thoughts. The program will address several areas important for long-term weight management, including coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Body Mass Index of 30 to 40
- Stable body weight
- Stage I, II, or IIIA breast cancer diagnosis within the past 5 years
- Completed chemotherapy or radiation therapy more than 3 months ago
Exclusion Criteria:
- Recurrence of cancer
- Currently following a special diet
- Uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling
Location Information
Call Center 800-karmanos
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
Call Center 800-karmanos
Zora Djuric, PhD, Principal Investigator
Diane Brown, PhD, Sub-Investigator
Kathryn Carolin, MD, Sub-Investigator
More Information
study flyer
Publications
Djuric Z, DiLaura NM, Jenkins I, Darga L, Jen CK, Mood D, Bradley E, Hryniuk WM. Combining weight-loss counseling with the weight watchers plan for obese breast cancer survivors. Obes Res. 2002 Jul;10(7):657-65.
Record last reviewed: December 2004
Last Updated: December 17, 2004
Record first received: April 28, 2004
ClinicalTrials.gov Identifier: NCT00082056
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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