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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: Completed NA study, sponsored by University of Pittsburgh.
NCT01500356 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 383 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Left ventricular mass will be assessed using cardiac MRI
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 |
What the finished NCT01500356 record still lists
NCT01500356 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Behavioral weight loss intervention is the first listed.
NCT01500356 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01500356's enrollment target sits among peer trials
383 273rd of 2000 higher than 1,728 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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