Clinical trial NCT03815214: Take Off Pounds After Stroke Trial (TOPS)
Official title: Take Off Pounds After Stroke Trial (TOPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Obesity
Overweight
Hemiparesis
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2019-01-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Proportion of subjects achieving at least a 5% weight loss
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Change in blood pressure
timeFrame: 12 weeks
measure: Change in Waist Circumference
timeFrame: 12 weeks
measure: Change in Body Mass Index
timeFrame: 12 weeks
measure: Change in modified Rankin scale
timeFrame: 12 weeks
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
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. 2024;53(1):54-61. doi: 10.1159/000530996. Epub 2023 May 15.