Status:
UNKNOWN
A Weight-Loss Program in Helping Obese Black Women Lose Weight
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
30-50 years
Phase:
PHASE3
Brief Summary
RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program may help obese black women lose weight. It is not yet known whether a weight-loss program is more effectiv...
Detailed Description
OBJECTIVES: Primary * To estimate the effectiveness of a 24-week diet and physical activity intervention and a 1-year maintenance intervention designed to produce and maintain weight loss in obese b...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Self-identified as Black or African-American
- Body mass index ≥ 30 kg/m²
- PATIENT CHARACTERISTICS:
- Pre- or perimenopausal
- Not pregnant or nursing
- Not planning to become pregnant
- Not planning to move from the Chicago area during the active and maintenance study interventions (18 months)
- No exercise intolerance due to chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, or exercise-induced asthma)
- No cancer requiring treatment within the past 5 years, except nonmelanoma skin cancer
- No diabetes
- No uncontrolled hypertension
- Participants on hypertensive medication may be eligible upon approval by the Investigator
- None of the following conditions:
- Unstable angina
- Orthostatic hypotension
- Moderate to severe aortic stenosis
- Uncontrolled arrhythmia
- Uncontrolled congestive heart failure
- Pulmonary embolism within the past 6 months
- History of cardiac arrest
- No significant mental illness (e.g., schizophrenia or unmedicated bipolar disorder)
- No alcohol intake of \> 2 drinks per day
- No illegal drug use
- No laxative abuse (i.e., \> twice the recommended dose)
- PRIOR CONCURRENT THERAPY:
- No concurrent treatment for an eating disorder
- No concurrent medications (e.g., hormone-replacement therapy) that could interfere with adherence to an exercise program or could interfere with study outcomes
- No concurrent participation in a formal weight-loss program
- No concurrent pharmacotherapy for weight loss
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00859989
Start Date
July 1 2004
Last Update
December 18 2013
Active Locations (1)
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1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243