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Weight-Loss Program for Obesity

Phase 3
Waitlist Available
Led By Marian Fitzgibbon, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre- or perimenopausal
No exercise intolerance due to chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, or exercise-induced asthma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare a weight-loss program with a general health education program to see if the weight-loss program is more effective for obese black women.

Who is the study for?
This trial is for obese Black or African-American women with a BMI of 30 kg/m² or higher, who are pre- or perimenopausal and not currently pregnant. They should have no history of cancer treatment in the past 5 years (except skin cancer), no diabetes, controlled hypertension, and must not be planning to move from Chicago during the study.Check my eligibility
What is being tested?
The study is testing a weight-loss program specifically designed for obese black women against a general health education program to see which is more effective at helping them lose weight. The goal is also to assess if weight loss reduces the risk of developing cancer.See study design
What are the potential side effects?
Since this trial involves diet and exercise interventions rather than medication, side effects may include typical responses to new physical activities such as muscle soreness, fatigue, and potential injury if exercises are performed incorrectly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am before or around the time of menopause.
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I do not have exercise intolerance due to lung conditions like COPD.
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I haven't needed treatment for any cancer except skin cancer in the last 5 years.
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I do not have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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 ...

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Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
608 Previous Clinical Trials
1,559,317 Total Patients Enrolled
33 Trials studying Obesity
9,623 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,168 Total Patients Enrolled
48 Trials studying Obesity
31,288 Patients Enrolled for Obesity
Marian Fitzgibbon, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
412 Total Patients Enrolled

Media Library

Weight-Loss Program Clinical Trial Eligibility Overview. Trial Name: NCT00859989 — Phase 3
Obesity Research Study Groups:
Obesity Clinical Trial 2023: Weight-Loss Program Highlights & Side Effects. Trial Name: NCT00859989 — Phase 3
Weight-Loss Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT00859989 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is an adult, do they meet the requirements for this research?

"Eligibility guidelines state that only individuals aged 30-50 may apply to this trial. However, there are 258 other clinical trials open to minors and 1985 trials open to seniors."

Answered by AI

Are there any documented negative effects of this treatment?

"This Phase 3 trial has yielded some data in support of the treatment's efficacy, as well as multiple rounds of data affirming its safety. Consequently, we have rated the safety of the treatment as a 3."

Answered by AI

Are people currently being signed up to participate in this clinical trial?

"No, this particular clinical trial is not currently enrolling patients according to the latest update on clinicaltrials.gov. The first posting was on July 1st, 2004 with the most recent update being December 17th, 2013. It's worth noting that there are 2432 other clinical trials that are still recruiting patients."

Answered by AI

Who would be an appropriate candidate for this research?

"200 individuals with breast cancer, aged between 30 and 50, are needed for this clinical trial. Eligibility requirements include: Body mass index ≥ 30 kg/m², 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."

Answered by AI
~10 spots leftby Apr 2025