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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815214
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Jennifer Dearborn-Tomazos, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Stroke Obesity Overweight Hemiparesis Behavioral: Partial meal replacement program Behavioral: Dietary Counseling Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor is blinded to study group assignment
Primary Purpose: Treatment
Official Title: Take Off Pounds After Stroke Trial (TOPS)
Actual Study Start Date : December 1, 2019
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : May 30, 2021

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




Primary Outcome Measures :
  1. Proportion of subjects achieving at least a 5% weight loss [ Time Frame: 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 Outcome Measures:
  1. Change in blood pressure [ Time Frame: 12 weeks ]
    Change in blood pressure from baseline to 12 weeks

  2. Change in Waist Circumference [ Time Frame: 12 weeks ]
    Change in waist circumference from baseline to 12 weeks

  3. Change in Body Mass Index [ Time Frame: 12 weeks ]
    Change in Body Mass Index from baseline to 12 weeks

  4. Change in modified Rankin scale [ Time Frame: 12 weeks ]
    Change in modified Rankin scale from baseline to 12 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815214


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Yale University
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Responsible Party: Jennifer Dearborn-Tomazos, Assistant Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03815214    
Other Study ID Numbers: 2018P000770
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Paresis
Overweight
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Body Weight
Neurologic Manifestations