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NCT01500356 · ClinicalTrials.gov registry record · NA
Effect of Exercise and Weight Loss on Cardiovascular Health
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 383
- Enrollment target
NCT01500356 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 383 participants.
The verdict
NCT01500356, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 383 participants
- Enrollment target
Study Summary
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity \[moderate physical activity (MOD-PA) = 150 min/wk\] versus a higher dose of physical activity \[high physical activity (HIGH-PA) = 250 min/wk\] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
Interventions
- BEHAVIORAL Behavioral weight loss intervention
- BEHAVIORAL Diet Plus Moderate Exercise
- BEHAVIORAL Diet Plus High Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2011-12-13 |
| Est. Completion | 2016-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500356
The ClinicalTrials.gov registry entry for NCT01500356 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 383 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Behavioral weight loss intervention is the first listed.
NCT01500356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01500356 about?
NCT01500356 is a clinical study titled "Effect of Exercise and Weight Loss on Cardiovascular Health". The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity \[moderate physical activity (MOD-PA) = 150 min/wk\] versus a higher dose of physical activity \[high physical activity (HIGH-PA) = 250 min/wk\] in the context of a comprehens...
What is the current status of trial NCT01500356?
This trial is currently completed. It is a NA study. The enrollment target is 383 participants. The study started on 2011-12-13. Estimated completion is 2016-06-30.
What interventions are being tested in trial NCT01500356?
The interventions under investigation include: Behavioral weight loss intervention (BEHAVIORAL), Diet Plus Moderate Exercise (BEHAVIORAL), Diet Plus High Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT01500356?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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