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Peer Counseling for Weight Loss

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss counseling
Sponsored by
Wayne State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring weight loss, survivorship, breast ductal lavage, exercise, diet

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wayne State UniversityRecruiting

Outcomes

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

Full Information

First Posted
July 6, 2005
Last Updated
September 4, 2008
Sponsor
Wayne State University
Collaborators
Barbara Ann Karmanos Cancer Institute, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00120029
Brief Title
Peer Counseling for Weight Loss
Official Title
Peer Counseling for Weight Loss in African American Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wayne State University
Collaborators
Barbara Ann Karmanos Cancer Institute, University of Michigan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
weight loss, survivorship, breast ductal lavage, exercise, diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
weight loss counseling
Primary Outcome Measure Information:
Title
weight loss
Secondary Outcome Measure Information:
Title
markers of oxidative stress in blood and breast fluid
Title
markers of cardiovascular health in blood
Title
body fat
Title
fitness

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Ford, BS
Phone
313-745-5774
Email
dford@med.wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zora Djuric, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Ford
Phone
313-745-5774
Email
dford@med.wayne.edu
First Name & Middle Initial & Last Name & Degree
Zora Djuric, PhD

12. IPD Sharing Statement

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Peer Counseling for Weight Loss

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