Clinical trial · Interventional
A Weight-Loss Program in Helping Obese Black Women Lose Weight
Obesity Reduction Black Intervention Trial (ORBIT)
NCT00859989CI-TRIAL-00013070unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| evaluation of cancer risk factors | Procedure | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Body mass index as assessed at baseline, 24 weeks, and 18 months
- measure
- Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months
Secondary outcomes (2)
- measure
- 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
- measure
- 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 ...
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.