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Peer Counseling for Weight Loss

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ClinicalTrials.gov Identifier: NCT00120029
Recruitment Status : Unknown
Verified June 2008 by Wayne State University.
Recruitment status was:  Recruiting
First Posted : July 14, 2005
Last Update Posted : September 5, 2008
Barbara Ann Karmanos Cancer Institute
University of Michigan
Information provided by:
Wayne State University

Brief Summary:
The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: weight loss counseling

Detailed Description:
Obesity has adverse effects on breast cancer survival and recurrence, and this may be mediated via the insulin resistance that is associated with obesity. This is a matter of exceptional concern for African-American (AA) breast cancer survivors since a greater proportion of AAs than European Americans (EA) are obese, insulin-resistant and diabetic. This proposal seeks to test the effects of weight loss intervention in obese and overweight AA breast cancer survivors (body mass index 25-40 kg/m2, stage I, II, or IIIA cancer, free of recurrence). Subjects (n=100) will be randomized across 3 arms: 1) control; 2) individualized, dietitian-led counseling; and 3) dietitian-led counseling combined with peer counseling using telephone counseling by trained peers who are AA breast cancer survivors successful at weight control. Psychosocial factors that can affect the extent of weight loss achieved will be assessed, including individual, home and community-level factors. Some of these factors may change when weight loss is achieved and will be assessed both before and after intervention. Genetic polymorphisms that have been shown to be associated with increased body weight, insulin resistance, lipid metabolism, and oxidative stress will be determined and related to both baseline and post-intervention anthropometric and biologic measures. This should further help elucidate inter-individual differences in response to weight loss intervention. The possible beneficial effects of weight loss on the health risks associated with obesity will be evaluated with measures of insulin resistance, insulin-like growth factor and lipid levels in blood samples, as well as with blood pressure and anthropometric measures. The effects of weight loss on these measures have been studied in other obese and overweight populations, but there is little data in breast cancer survivors. Finally, we will attempt to determine if beneficial effects of weight loss can be detected in the breast, since this should be related to subsequent breast cancer risk. The breast contralateral to surgery will be subjected to ductal lavage at baseline, 12 and 24 months. The investigators will examine the effects of weight change on markers of oxidative stress in the breast nipple aspirate fluid that is obtained as part of the lavage procedure. Levels of lipid peroxidation are very high in this fluid and have been related to both nuclear atypia and breast cancer risk. The nuclear morphology of epithelial cells obtained by ductal lavage therefore will be quantified as well. Weight loss in obese and overweight AA breast cancer survivors should improve both psychosocial function and biological indicators of health risks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer Counseling for Weight Loss in African American Breast Cancer Survivors
Study Start Date : January 2004
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. weight loss

Secondary Outcome Measures :
  1. markers of oxidative stress in blood and breast fluid
  2. markers of cardiovascular health in blood
  3. body fat
  4. fitness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Overweight or obese
  • African American
  • Up to 7 years post breast cancer diagnosis
  • Able to keep food records
  • Have a telephone
  • Stable weight within 5 pounds last 2 months

Exclusion Criteria:

  • Breast cancer recurrence
  • History of other cancers
  • Uncontrolled congestive heart failure
  • Untreated hypertension
  • Disabling osteoarthritis
  • Abusing drugs or alcohol
  • Have psychiatric conditions that interfere with counseling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120029

Contact: Donna Ford, BS 313-745-5774 dford@med.wayne.edu

United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Donna Ford    313-745-5774    dford@med.wayne.edu   
Principal Investigator: Zora Djuric, PhD         
Sponsors and Collaborators
Wayne State University
Barbara Ann Karmanos Cancer Institute
University of Michigan
Principal Investigator: Zora Djuric, PhD University of Michigan

ClinicalTrials.gov Identifier: NCT00120029     History of Changes
Other Study ID Numbers: 057103MP4F
1P50ES012395 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: June 2008

Keywords provided by Wayne State University:
weight loss
breast ductal lavage

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms