Status:
COMPLETED
Take Off Pounds After Stroke Trial (TOPS)
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Yale University
Conditions:
Stroke
Obesity
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard...
Eligibility Criteria
Inclusion
- Acute ischemic stroke within 90 days of randomization
- Age \>=18
- BMI 27-49.9 mg/kg2
- Able to meet all nutritional and fluid needs by oral intake.
- Ready to undergo behavioral change
- Able and willing to provide written informed consent
- Maximum weight \<=350 lbs
Exclusion
- Medical contraindication to weight loss or diet, including the following: renal disease requiring dialysis, taking lithium, or end stage liver or renal disease considered incompatible with diet intervention by patient's personal healthcare provider or the study PI
- Enrollment in a conflicting clinical trial (defined as a trial with an intervention known to affect weight or with an exclusion for participation in another trial)
- Pregnancy or desire to become pregnant, or currently breastfeeding
- High-risk of malnutrition using a standard screen
- Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months preceding screening)
- Allergy to soy based food products
- Require thickening of liquids due to dysphagia
- Inability to communicate with study team
- Inability to speak English
- Irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03815214
Start Date
December 1 2019
End Date
May 30 2021
Last Update
August 23 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115