Take Off Pounds After Stroke Trial (TOPS) (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 physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.

Study Overview

• Status: Completed
• Conditions: Stroke; Obesity; Overweight; Hemiparesis
• Intervention / Treatment: Behavioral: Partial meal replacement program; Behavioral: Dietary Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Change in blood pressure from baseline to 12 weeks	12 weeks
Change in Waist Circumference	Change in waist circumference from baseline to 12 weeks	12 weeks
Change in Body Mass Index	Change in Body Mass Index from baseline to 12 weeks	12 weeks
Change in modified Rankin scale	Change in modified Rankin scale from baseline to 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Yale University

Publications and helpful links

General Publications

• 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. 2023 May 15. doi: 10.1159/000530996. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Overnutrition; Nutrition Disorders; Body Weight; Stroke; Overweight; Paresis
• Other Study ID Numbers: 2018P000770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No