- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859989
A Weight-Loss Program in Helping Obese Black Women Lose Weight
Obesity Reduction Black Intervention Trial (ORBIT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: laboratory biomarker analysis
- Other: immunoenzyme technique
- Other: questionnaire administration
- Procedure: support group therapy
- Procedure: evaluation of cancer risk factors
- Behavioral: telephone-based intervention
- Other: educational intervention
- Other: counseling intervention
- Other: study of socioeconomic and demographic variables
- Behavioral: behavioral dietary intervention
- Behavioral: exercise intervention
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.
OUTLINE: Participants are randomized to 1 of 2 intervention arms.
- Arm I (weight-loss intervention): Participants undergo a combined weight-loss intervention (diet and physical activity) over 24 weeks comprising individualized sessions with an interventionist once monthly and group sessions twice weekly. During the group sessions, participants receive information about diet, physical activity, and weight loss and take part in exercise classes. Participants receive handouts, food-measuring tools, and pedometers. Participants also discuss goal setting and problem solving. During the individualized sessions, participants undergo motivational interviewing (MI) to assess their individual needs and to motivate them to make or sustain behavioral changes.
Beginning 1 month after completion of the combined weight-loss intervention, participants undergo a weight-loss maintenance intervention over 12 months. Participants continue their exercise classes twice weekly and receive a copy of the aerobic exercise class videotape for use at home. Prior to each exercise session, participants may share their weight-loss experiences (e.g., successes, struggles) or a motivational or informational story, article, or prayer with other group members. Participants also receive weekly newsletters that include information presented in the original weight-loss intervention, opportunities in the community for physical activity (e.g., ice skating, swimming, or local walks), and further advice on maintaining weight loss. Participants undergo 4 MI sessions over the telephone that address diet, physical activity, and weight-loss maintenance strategies. The MI sessions also provide an opportunity for individualized problem solving.
- Arm II (control intervention): Participants undergo a control intervention over 24 weeks comprising weekly newsletters on general health topics, such as first aid, smoking cessation, cancer screening, and disease prevention, and monthly general health classes that demonstrate information conveyed in the newsletter (e.g., first-aid techniques).
After completion of the control intervention, participants undergo a control maintenance intervention over 12 months comprising a monthly newsletter on general health topics. After completion of the maintenance intervention, participants undergo 10 intervention sessions and receive the same study-related materials (handouts, food-measuring tools, and pedometers) as in arm I.
Blood samples are collected at baseline, 24 weeks, and 18 months for laboratory biomarker studies. Samples are analyzed for insulin levels by radioimmunoassay, glucose concentrations, and total and free IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 by enzyme-linked immunoassay.
Participants complete questionnaires at baseline, 24 weeks, and 18 months to assess diet, physical activity, cognitive measures (attitudes, beliefs, and self-efficacy), social support, and environmental measures.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612-7243
- University of Illinois Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome 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
|
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 ...
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000635687
- UIC-2004-0748
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on laboratory biomarker analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States