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Breast CancerNCT00120029

Peer Counseling for Weight Loss

A study testing weight loss counseling in people with Breast Cancer, run by Wayne State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 71 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
weight loss counseling
How many people
100 participants
Where
1 siteUnited States
Study dates
Jan 2004to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 71 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Donna Ford, BS contact

313-745-5774

dford@med.wayne.edu

United States1 site, 1 recruiting
  • Wayne State University

    Detroit, Michigan, 48201

    Donna Ford, 313-745-5774, dford@med.wayne.edu

    Zora Djuric, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
weight loss counseling
Keywords
weight loss, survivorship, breast ductal lavage, exercise, diet
Medical subject headings
Breast Neoplasms, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • weight loss counselingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight loss

Secondary outcomes (4)
  1. markers of oxidative stress in blood and breast fluid

  2. markers of cardiovascular health in blood

  3. body fat

  4. fitness

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2005 (estimated)
  2. Study startJan 2004
  3. Study completionJun 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120029
Sponsor's protocol ID
057103MP4F
Other IDs
1P50ES012395
Status last verified
Jun 2008
First submitted
6 Jul 2005
Last updated
5 Sep 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing weight loss counseling in people with Breast Cancer, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Donna Ford, BS (313-745-5774, dford@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight loss. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2008.

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