Hemiparesis, Obesity, Overweight, Stroke
Conditions
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.
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 care, in achieving clinically significant weight loss without impairment of physical function when initiated within 90 days following ischemic stroke in patients with BMI 27-to-49.9 kg/m2. 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.
Interventions
BEHAVIORALPartial meal replacement program
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.
BEHAVIORALDietary Counseling
Participants will receive one 45-minute counseling session on a healthy diet
Sponsors
Yale University
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor is blinded to study group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Acute ischemic stroke within 90 days of randomization 2. Age \>=18 3. BMI 27-49.9 mg/kg2 4. Able to meet all nutritional and fluid needs by oral intake. 5. Ready to undergo behavioral change 6. Able and willing to provide written informed consent 7. Maximum weight \<=350 lbs
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 screen 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. Require thickening of liquids due to dysphagia 8. Inability to communicate with study team 9. Inability to speak English 10. Irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving at least a 5% weight loss | 12 weeks | Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | 12 weeks | Change in blood pressure from baseline to 12 weeks |
| Change in Waist Circumference | 12 weeks | Change in waist circumference from baseline to 12 weeks |
| Change in Body Mass Index | 12 weeks | Change in Body Mass Index from baseline to 12 weeks |
| Change in modified Rankin scale | 12 weeks | Change in modified Rankin scale from baseline to 12 weeks |
Countries
United States
Outcome results
None listed