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Peer Counseling for Weight Loss

NCT ID: NCT00120029

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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weight loss survivorship breast ductal lavage exercise diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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weight loss counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Principal Investigators

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Zora Djuric, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Donna Ford, BS

Role: CONTACT

Phone: 313-745-5774

Email: [email protected]

Facility Contacts

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Donna Ford

Role: primary

Other Identifiers

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1P50ES012395

Identifier Type: NIH

Identifier Source: secondary_id

View Link

057103MP4F

Identifier Type: -

Identifier Source: org_study_id