A Weight-Loss Program in Helping Obese Black Women Lose Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00859989
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2009
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 effective than a general health education program in helping obese black women lose weight. Weight loss may reduce a person's risk of developing cancer.

PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it works in helping obese black women lose weight.

Condition or disease Intervention/treatment Phase
Breast Cancer Obesity Weight Changes Behavioral: behavioral dietary intervention Behavioral: exercise intervention Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Other: immunoenzyme technique Other: laboratory biomarker analysis Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: evaluation of cancer risk factors Procedure: support group therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Official Title: Obesity Reduction Black Intervention Trial (ORBIT)
Study Start Date : July 2004
Estimated Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Body mass index as assessed at baseline, 24 weeks, and 18 months
  2. Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months

Secondary Outcome Measures :
  1. Changes in diet and physical activity as assessed by Block 98 FFQ and Stanford 7-Day Physical Activity Recall questionnaires at baseline, 24 weeks, and 18 months
  2. Changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss as assessed by Nutrition Attitudes Scale, Self-Efficacy for Eating and Exercise Behaviors, and Social Support for Eating and Exerci ...

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Self-identified as Black or African-American
  • Body mass index ≥ 30 kg/m²


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00859989

United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
Principal Investigator: Marian Fitzgibbon, PhD University of Illinois at Chicago

Responsible Party: Marian Fitzgibbon, University of Illinois Cancer Center Identifier: NCT00859989     History of Changes
Other Study ID Numbers: CDR0000635687
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: March 2009

Keywords provided by National Cancer Institute (NCI):
breast cancer
weight changes

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Nutrition Disorders
Signs and Symptoms