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Weight Loss Counseling for African American Breast Cancer Survivors
This study has been completed.
Sponsors and Collaborators: National Cancer Institute (NCI)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00082056
  Purpose

The purpose of this study is to develop a weight loss intervention for obese African American breast cancer survivors.


Condition Intervention
Obesity
Breast Neoplasms
Behavioral: Spirituality Counseling for Weight Management

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Obesity Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Culturally-Tailored Weight Loss Program

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • weight change [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
control: No Intervention
continue own usual diet
liefstyle counseling: Experimental
telephone counseling for diet and exercise
Behavioral: Spirituality Counseling for Weight Management

Detailed Description:

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 to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082056

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Investigators
Study Director: Zora Djuric University of Michigan
Principal Investigator: Michael Simon Wayne State University
  More Information

study flyer  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Weight loss
Spirituality

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Skin Diseases
Weight Loss
Body Weight Changes
Nutrition Disorders
Breast Neoplasms
Overweight
Overnutrition
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009