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NCT00774371 · ClinicalTrials.gov registry record · NA
Weight Reduction Intervention for Breast Cancer Survivors
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 253
- Enrollment target
NCT00774371 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 253 participants.
The verdict
NCT00774371, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 253 participants
- Enrollment target
Study Summary
Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse effect of excess body fat on prognosis following the diagnosis of breast cancer, including increased circulating sex hormones, insulin, leptin, and various growth factors. Results from previous studies suggest that specific strategies can facilitate weight reduction and maintenance of weight loss in this target population. This randomized clinical trial will recruit 253 overweight or obese women who have been previously treated for early stage breast cancer and will test whether a multifaceted approach to promoting healthy weight management can achieve the goal of weight loss and maintenance. Additionally, this study tests whether weight loss is associated with changes in biological and psychosocial factors, including eating attitudes and behaviors and health-related quality of life. The intervention incorporates cognitive-behavioral therapy, increased physical activity, diet modification to facilitate a modest reduction in energy intake, and strategies to improve body image and self-acceptance. This approach and intervention have been pilot-tested with breast cancer survivors in a developmental project, which resulted in the intervention group losing significantly more weight than the wait-list control group. Study Aims include: testing whether an intervention that emphasizes increased physical activity and individualized diet modification to promote an energy imbalance is associated with a greater degree of weight loss and maintenance of that loss over an 18-month time period; describing the effect of the intervention on hormones and growth factors; describing the relationships between body weight and weight reduction and measures of selected psychosocial factors. Measurements of hormonal and psychosocial factors in this study will provide insight into the responsiveness of these fa
Interventions
- BEHAVIORAL Cognitive behavioral therapy CBT) for weight loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2005-01 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00774371
The ClinicalTrials.gov registry entry for NCT00774371 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 253 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive behavioral therapy CBT) for weight loss is the first listed.
NCT00774371 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00774371 about?
NCT00774371 is a clinical study titled "Weight Reduction Intervention for Breast Cancer Survivors". Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse effect of excess body fat on prognosis following the diagnosis of breast cancer, including increased circulating sex...
What is the current status of trial NCT00774371?
This trial is currently completed. It is a NA study. The enrollment target is 253 participants. The study started on 2005-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00774371?
The interventions under investigation include: Cognitive behavioral therapy CBT) for weight loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT00774371?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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