- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120029
Peer Counseling for Weight Loss
September 4, 2008 updated by: Wayne State University
Peer Counseling for Weight Loss in African American Breast Cancer Survivors
The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors.
Study Overview
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
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Donna Ford, BS
- Phone Number: 313-745-5774
- Email: dford@med.wayne.edu
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201
- Recruiting
- Wayne State University
-
Contact:
- Donna Ford
- Phone Number: 313-745-5774
- Email: dford@med.wayne.edu
-
Principal Investigator:
- Zora Djuric, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
weight loss
|
Secondary Outcome Measures
Outcome Measure |
---|
fitness
|
markers of oxidative stress in blood and breast fluid
|
markers of cardiovascular health in blood
|
body fat
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zora Djuric, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
July 6, 2005
First Submitted That Met QC Criteria
July 6, 2005
First Posted (Estimate)
July 14, 2005
Study Record Updates
Last Update Posted (Estimate)
September 5, 2008
Last Update Submitted That Met QC Criteria
September 4, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 057103MP4F
- 1P50ES012395 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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