StrokePhase 2TOPSNCT03815214
Take Off Pounds After Stroke Trial (TOPS)
A Phase 2 study testing Partial meal replacement program and Dietary Counseling in people with Stroke and Obesity, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Obesity, Overweight
- What is being tested?
- Partial meal replacement program and Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2019to 30 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- Stroke, Obesity, Overweight, Hemiparesis
- Being tested
- Partial meal replacement program, Dietary Counseling
- Medical subject headings
- Stroke, Obesity, Overweight, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial meal replacement programBehavioural
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 CounselingBehavioural
Participants will receive one 45-minute counseling session on a healthy diet
| Study group | Role | What they receive |
|---|---|---|
| Diet Intervention | Experimental | 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. Receives: Behavioral: Partial meal replacement program |
| Enhanced Standard Care | Placebo comparator | The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture. Receives: Behavioral: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Dec 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Jennifer Dearborn-Tomazos, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815214
- Sponsor's protocol ID
- 2018P000770
- Acronym
- TOPS
- Status last verified
- Aug 2023
- First submitted
- 22 Jan 2019
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37231793
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Off Pounds After Stroke Trial (TOPS)
- ClinicalTrials.gov ID
- NCT03815214
- Acronym / sponsor ID
- TOPS / 2018P000770
- Conditions
- Stroke, Obesity, Overweight, Hemiparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Intervention | Experimental | Behavioral: Partial meal replacement programThe 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. |
| Enhanced Standard Care | Placebo comparator | Behavioral: Dietary CounselingThe control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial meal replacement programFour 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. | Behavioural | Diet Intervention |
| Dietary CounselingParticipants will receive one 45-minute counseling session on a healthy diet | Behavioural | Enhanced Standard Care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Results publication: PubMed 37231793Dearborn 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partial meal replacement program and Dietary Counseling in people with Stroke and Obesity, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving at least a 5% weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.