Take Off Pounds After Stroke Trial (TOPS)

Beth Israel Deaconess Medical Center38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Obesity Overweight Hemiparesis

Interventions

Partial meal replacement programBEHAVIORAL

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.

Dietary CounselingBEHAVIORAL

Participants will receive one 45-minute counseling session on a healthy diet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (2)

Yale New Haven Hospital

New Haven, Connecticut, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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