Take Off Pounds After Stroke Trial (TOPS)

Obesity Clinical Trial

— TOPS  

Official title:

Take Off Pounds After Stroke Trial (TOPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815214
• Other study ID #: 2018P000770
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemiparesis
• Obesity
• Overweight
• Paresis
• Stroke

Intervention

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.
• Dietary Counseling
Participants will receive one 45-minute counseling session on a healthy diet

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood pressure	Change in blood pressure from baseline to 12 weeks	12 weeks
Other	Change in Waist Circumference	Change in waist circumference from baseline to 12 weeks	12 weeks
Other	Change in Body Mass Index	Change in Body Mass Index from baseline to 12 weeks	12 weeks
Other	Change in modified Rankin scale	Change in modified Rankin scale from baseline to 12 weeks	12 weeks
Primary	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