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Take Off Pounds After Stroke Trial (TOPS) (TOPS)

Primary Purpose

Stroke, Obesity, Overweight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Partial meal replacement program
Dietary Counseling
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale New Haven Hospital
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diet Intervention

Enhanced Standard Care

Arm Description

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.

The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 22, 2019
Last Updated
August 21, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT03815214
Brief Title
Take Off Pounds After Stroke Trial (TOPS)
Acronym
TOPS
Official Title
Take Off Pounds After Stroke Trial (TOPS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Obesity, Overweight, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor is blinded to study group assignment
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Standard Care
Arm Type
Placebo Comparator
Arm Description
The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.
Intervention Type
Behavioral
Intervention Name(s)
Partial meal replacement program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counseling
Intervention Description
Participants will receive one 45-minute counseling session on a healthy diet
Primary Outcome Measure Information:
Title
Proportion of subjects achieving at least a 5% weight loss
Description
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
Other Pre-specified Outcome Measures:
Title
Change in blood pressure
Description
Change in blood pressure from baseline to 12 weeks
Time Frame
12 weeks
Title
Change in Waist Circumference
Description
Change in waist circumference from baseline to 12 weeks
Time Frame
12 weeks
Title
Change in Body Mass Index
Description
Change in Body Mass Index from baseline to 12 weeks
Time Frame
12 weeks
Title
Change in modified Rankin scale
Description
Change in modified Rankin scale from baseline to 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
37231793
Citation
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.
Results Reference
result

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Take Off Pounds After Stroke Trial (TOPS)

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