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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00859989
First received: March 10, 2009
Last updated: December 17, 2013
Last verified: March 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Obesity Reduction Black Intervention Trial (ORBIT)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Body mass index as assessed at baseline, 24 weeks, and 18 months [ Designated as safety issue: No ]
  • Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • 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 ... [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2004
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859989

Locations
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Marian Fitzgibbon, PhD University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Marian Fitzgibbon, University of Illinois Cancer Center
ClinicalTrials.gov Identifier: NCT00859989     History of Changes
Other Study ID Numbers: CDR0000635687, UIC-2004-0748
Study First Received: March 10, 2009
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Breast Neoplasms
Obesity
Breast Diseases
Neoplasms
Neoplasms by Site
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014