Take Off Pounds After Stroke Trial (TOPS)
TOPS
1 other identifier
interventional
38
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Dec 2019
Shorter than P25 for phase_2 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedAugust 23, 2023
August 1, 2023
1.5 years
January 22, 2019
August 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving at least a 5% weight loss
Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group
12 weeks
Other Outcomes (4)
Change in blood pressure
12 weeks
Change in Waist Circumference
12 weeks
Change in Body Mass Index
12 weeks
- +1 more other outcomes
Study Arms (2)
Diet Intervention
EXPERIMENTALThe diet intervention is a partial meal replacement program using the commercially available OPTAVIA® Optimal Weight 4\&2\&1 Plan™. In the OPTAVIA program, subjects are asked to eat 6 times each day, once every 2 to 3 hours.
Enhanced Standard Care
PLACEBO COMPARATORThe control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.
Interventions
Four meals consist of meal replacements made by OPTAVIA, such as shakes, soups, bars, biscuits, hot drinks, and puddings. Meal replacements will be provided to subjects without charge. For two other daily meals, subjects or their caregivers will be taught how to prepare meals consisting of 5-7 ounces (cooked) of a low-fat protein, 3 servings of non-starchy vegetables, and up to 2 servings of healthy fats.
Participants will receive one 45-minute counseling session on a healthy diet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Yale Universitycollaborator
Study Sites (2)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Related Publications (1)
Dearborn Tomazos J, Viscoli C, Amin H, Lovelett LJ, Rivera J, Gull A, Kernan WN. Partial Meal Replacement for Weight Loss after Stroke: Results of a Pilot Clinical Trial. Cerebrovasc Dis. 2024;53(1):54-61. doi: 10.1159/000530996. Epub 2023 May 15.
PMID: 37231793RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor is blinded to study group assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 24, 2019
Study Start
December 1, 2019
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
The findings from this study will be presented at scientific meetings and published in scientific journals without revealing the identity of the subjects. The investigators plan to acknowledge the study subjects for their participation. The overall results of the study will be shared with the participants, accompanied by a thank you note, upon publication of the final results.