Skip to main content
Clinical Trials/NCT00859989
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

Sponsor Class
Other

Study Sites (2)

Loading locations...

Similar Trials