NCT00859989UnknownPhase 3
Obesity Reduction Black Intervention Trial (ORBIT)
University of Illinois at Chicago2 sites in 1 country200 target enrollmentStarted: July 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Body mass index as assessed at baseline, 24 weeks, and 18 months
Study Overview
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.
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 black women.
- To estimate the effect of these interventions on changes in fasting serum insulin, glucose, and free IGF-1, IGFBP-1, and IGFBP-2 levels as well as total IGF-1 and IGFBP-3 levels.
Secondary
- To compare changes in dietary consumption of total calories, total fat, fruits, vegetables, and fiber as well as physical activity in participants undergoing a weight-loss intervention vs a control intervention.
- To compare changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss in participants undergoing a weight-loss intervention vs a control intervention.
- Assess the efficacy of a weight-loss intervention mechanism and the association between weight loss and weight loss maintenance with potential biologic mediators of breast cancer risk.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- 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 ...
Investigators
Study Sites (2)
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