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Sponsors and Collaborators: |
National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00082056 |
The purpose of this study is to develop a weight loss intervention for obese African American breast cancer survivors.
Condition | Intervention |
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Obesity Breast Neoplasms |
Behavioral: Spirituality Counseling for Weight Management |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Culturally-Tailored Weight Loss Program |
Enrollment: | 31 |
Study Start Date: | May 2004 |
Study Completion Date: | October 2008 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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control: No Intervention
continue own usual diet
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liefstyle counseling: Experimental
telephone counseling for diet and exercise
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Behavioral: Spirituality Counseling for Weight Management |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 |
Study Director: | Zora Djuric | University of Michigan |
Principal Investigator: | Michael Simon | Wayne State University |
Responsible Party: | University of Michigan ( Zora Djuric ) |
Study ID Numbers: | R21 CA100720 |
Study First Received: | April 28, 2004 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00082056 |
Health Authority: | United States: Federal Government |
Weight loss Spirituality |
Body Weight Signs and Symptoms Obesity Skin Diseases Weight Loss Body Weight Changes |
Nutrition Disorders Breast Neoplasms Overweight Overnutrition Breast Diseases |
Neoplasms Neoplasms by Site |