Peer Counseling for Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Wayne State University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Barbara Ann Karmanos Cancer Institute
University of Michigan
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT00120029
First received: July 6, 2005
Last updated: September 4, 2008
Last verified: June 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peer Counseling for Weight Loss in African American Breast Cancer Survivors

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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

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

ClinicalTrials.gov processed this record on July 20, 2014