Take Off Pounds After Stroke Trial (TOPS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Take Off Pounds After Stroke Trial (TOPS)

Conditions
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Stroke, Obesity, Overweight, Hemiparesis

Intervention / Treatment
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* Behavioral: Partial meal replacement program
* Behavioral: Dietary Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Intervention<br>The 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. | Behavioral: Partial meal replacement program<br>* 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.<br>|
| Placebo Comparator: Enhanced Standard Care<br>The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture. | Behavioral: Dietary Counseling<br>* Participants will receive one 45-minute counseling session on a healthy diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |