Take Off Pounds After Stroke Trial (TOPS)
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 loss without impairment of motor recovery in patients with
 elevated body mass index (BMI) and upper extremity weakness following a recent ischemic
 stroke.
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 care, in achieving clinically significant weight loss without impairment of
 motor recovery when initiated within 30 days following ischemic stroke in patients with BMI
 27-to-49.9 kg/m2 and an upper-extremity motor deficit.

 Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet
 intervention) or enhanced standard care (control) with randomization stratified by
 recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency
 Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a
 stratification factor because it is expected that patients with difficulty swallowing
 (dysphagia) after stroke that results in need for modifications to food/liquids will have a
 different weight loss trajectory than patients who are able to safely consume a regular
 diet.The follow-up duration will be 12 weeks for all subjects.
Inclusion Criteria:

 1. Acute ischemic stroke within 30 days of randomization

 2. Age 18-80 years

 3. BMI 27-49.9 mg/kg2

 4. New or worse unilateral upper extremity weakness attributable to index stroke

 5. Score of 0-54 on the Fugl-Meyer upper extremity scale

 6. Able to meet all nutritional and fluid needs by oral intake.

 7. Ready to undergo behavioral change

 8. Able and willing to sign document outlining importance of following the study protocol

 9. Able and willing to provide written informed consent

 Exclusion Criteria:

 1. 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

 2. 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)

 3. Pregnancy or desire to become pregnant, or currently breastfeeding

 4. High-risk of malnutrition using a standard screen73

 5. Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months
 preceding screening)

 6. Allergy to soy based food products

 7. Inability to communicate with study team

 8. Inability to speak English

 9. Irreversible medical conditions likely to affect short-term survival (predicted
 survival of less than one year)