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Peer Counseling for Weight Loss

This study is currently recruiting participants.
Verified by Wayne State University, June 2008

Sponsors and Collaborators: Wayne State University
Barbara Ann Karmanos Cancer Institute
University of Michigan
Information provided by: Wayne State University
ClinicalTrials.gov Identifier: NCT00120029
  Purpose

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


Condition Intervention
Breast Cancer
Behavioral: weight loss counseling

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Weight Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Peer Counseling for Weight Loss in African American Breast Cancer Survivors

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • weight loss

Secondary Outcome Measures:
  • markers of oxidative stress in blood and breast fluid
  • markers of cardiovascular health in blood
  • body fat
  • fitness

Estimated Enrollment:   100
Study Start Date:   January 2004
Estimated Study Completion Date:   June 2008

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.

  Eligibility
Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120029

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

Locations
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

Investigators
Principal Investigator:     Zora Djuric, PhD     University of Michigan    
  More Information


A project within the Center for Urban and African American Health  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   057103MP4F, 1P50 ES012395
First Received:   July 6, 2005
Last Updated:   September 4, 2008
ClinicalTrials.gov Identifier:   NCT00120029
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Skin Diseases
Weight Loss
Body Weight Changes
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 28, 2008




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