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| ID | Type | Description | Link |
|---|---|---|---|
| 013003B3E | Other Identifier | Wayne State University - Human Investigation Committee |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietitian-led counseling and Weight Watchers | 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. |
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| Dietitian & Weight Watchers + Spirituality Counseling | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | 18 months |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer within the past 5 years
Identified as African American
Body Mass Index 30-40
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Two groups to participate:
Group 1: Dietitian led counseling and Weight Watchers groups for 18 months Group 2: Dietitian led counseling and Weight Watchers groups for 18 months with Spirituality counseling from 6 to 18 months.
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| Name | Affiliation | Role |
|---|---|---|
| Michael S. Simon, MD, MPH | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19585923 | Result | Djuric Z, Mirasolo J, Kimbrough L, Brown DR, Heilbrun LK, Canar L, Venkatranamamoorthy R, Simon MS. A pilot trial of spirituality counseling for weight loss maintenance in African American breast cancer survivors. J Natl Med Assoc. 2009 Jun;101(6):552-64. doi: 10.1016/s0027-9684(15)30940-8. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Spiritual counseling | Other | Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |