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

• ClinicalTrials.gov Identifier: NCT03815214
• Recruitment Status: Completed
• First Posted: January 24, 2019
• Last Update Posted: June 1, 2022
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Yale University
• Information provided by (Responsible Party): Jennifer Dearborn-Tomazos, Beth Israel Deaconess Medical Center

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

More Information

• 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
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Paresis; Overweight; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Weight; Neurologic Manifestations