Peer Counseling for Weight Loss

Breast Cancer Clinical Trial

Official title:

Peer Counseling for Weight Loss in African American Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00120029
• Other study ID #: 057103MP4F
• Secondary ID: 1P50ES012395
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2005
• Last updated: September 4, 2008
• Start date: January 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Wayne State University
• Contact: Donna Ford, BS
• Phone: 313-745-5774
• Email: dford[@]med.wayne.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 71 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Weight Loss

Intervention

Behavioral:
• weight loss counseling

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	Barbara Ann Karmanos Cancer Institute, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss
Secondary	markers of oxidative stress in blood and breast fluid
Secondary	markers of cardiovascular health in blood
Secondary	body fat
Secondary	fitness

External Links

•   A project within the Center for Urban and African American Health