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NCT03815214 · ClinicalTrials.gov registry record · Phase 2
Take Off Pounds After Stroke Trial (TOPS)
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT03815214: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT03815214 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815214, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.
Primary Outcome
Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group
Interventions
- BEHAVIORAL Dietary Counseling
- BEHAVIORAL Partial meal replacement program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2021-05-30 |
| Phase | Phase 2 |
What the finished NCT03815214 record still lists
NCT03815214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Dietary Counseling is the first listed.
NCT03815214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815214 about?
NCT03815214 is a clinical study titled "Take Off Pounds After Stroke Trial (TOPS)". The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight...
What is the current status of trial NCT03815214?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2019-12-01. Estimated completion is 2021-05-30.
What interventions are being tested in trial NCT03815214?
The interventions under investigation include: Dietary Counseling (BEHAVIORAL), Partial meal replacement program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03815214?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815214's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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