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

NCT00859989 | Unknown Phase 3

• 2 other identifiers: CDR0000635687UIC-2004-0748
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Obesity; Weight Changes

Keywords

breast cancer; weight changes; obesity

Outcome Measures

Primary Outcomes (2)

• Body mass index as assessed at baseline, 24 weeks, and 18 months

• Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months

Secondary Outcomes (2)

• 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

• 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 ...

Interventions

behavioral dietary intervention BEHAVIORAL

exercise intervention BEHAVIORAL

telephone-based intervention BEHAVIORAL

counseling intervention OTHER

educational intervention OTHER

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

questionnaire administration OTHER

study of socioeconomic and demographic variables OTHER

evaluation of cancer risk factors PROCEDURE

support group therapy PROCEDURE

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Body Weight Changes

Interventions

Counseling; Early Intervention, Educational; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Marian Fitzgibbon, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: July 1, 2004
• Primary Completion: April 1, 2009
• Last Updated: December 18, 2013

Record last verified: 2009-03

Locations

US (1)