NCT00120029

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 5, 2008

Status Verified

June 1, 2008

First QC Date

July 6, 2005

Last Update Submit

September 4, 2008

Conditions

Breast Cancer

Keywords

weight losssurvivorshipbreast ductal lavageexercisediet

Outcome Measures

Primary Outcomes (1)

  • weight loss

Secondary Outcomes (4)

  • markers of oxidative stress in blood and breast fluid

  • markers of cardiovascular health in blood

  • body fat

  • fitness

Interventions

weight loss counselingBEHAVIORAL

Eligibility Criteria

Age18 Years - 71 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsWeight LossMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Zora Djuric, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Ford, BS

CONTACT

313-745-5774dford@med.wayne.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

January 1, 2004

Study Completion

June 1, 2008

Last Updated

September 5, 2008

Record last verified: 2008-06

Locations

US(1)