Breast CancerPhase 3NCT00859989
A Weight-Loss Program in Helping Obese Black Women Lose Weight
A Phase 3 study testing behavioral dietary intervention, exercise intervention and telephone-based intervention in people with Breast Cancer and Obesity, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Breast Cancer, Obesity, Weight Changes
- What is being tested?
- behavioral dietary intervention, exercise intervention and telephone-based intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Obesity, Weight Changes
- Being tested
- behavioral dietary intervention, exercise intervention, telephone-based intervention, counseling intervention, educational intervention
- Keywords
- breast cancer, weight changes, obesity
- Medical subject headings
- Breast Neoplasms, Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
exercise interventionBehavioural
telephone-based interventionBehavioural
counseling interventionOther
educational interventionOther
immunoenzyme techniqueOther
laboratory biomarker analysisOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
evaluation of cancer risk factorsProcedure or surgery
support group therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startJul 2004
- Primary completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Marian Fitzgibbon, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859989
- Sponsor's protocol ID
- CDR0000635687
- Other IDs
- UIC-2004-0748
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Reduction Black Intervention Trial (ORBIT)
- ClinicalTrials.gov ID
- NCT00859989
- Acronym / sponsor ID
- CDR0000635687
- Conditions
- Breast Cancer, Obesity, Weight Changes
- Keywords
- breast cancer, weight changes, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Apr 2009 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral dietary intervention | Behavioural | – |
| exercise intervention | Behavioural | – |
| telephone-based intervention | Behavioural | – |
| 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 or surgery | – |
| support group therapy | Procedure or surgery | – |
Primary outcome
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
2 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 ...
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Fitzgibbon, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing behavioral dietary intervention, exercise intervention and telephone-based intervention in people with Breast Cancer and Obesity, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index as assessed at baseline, 24 weeks, and 18 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.