<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815214</url>
  </required_header>
  <id_info>
    <org_study_id>2018P000770</org_study_id>
    <nct_id>NCT03815214</nct_id>
  </id_info>
  <brief_title>Take Off Pounds After Stroke Trial (TOPS)</brief_title>
  <acronym>TOPS</acronym>
  <official_title>Take Off Pounds After Stroke Trial (TOPS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded&#xD;
      Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial&#xD;
      meal replacement program, compared to enhanced standard care, for efficacy in achieving&#xD;
      clinically significant weight loss without impairment of physical function patients with&#xD;
      elevated body mass index (BMI) following a recent ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of&#xD;
      a 12-week high protein, calorie restricted, partial meal replacement program, compared to&#xD;
      enhanced standard care, in achieving clinically significant weight loss without impairment of&#xD;
      physical function when initiated within 90 days following ischemic stroke in patients with&#xD;
      BMI 27-to-49.9 kg/m2.&#xD;
&#xD;
      Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet&#xD;
      intervention) or enhanced standard care (control) with randomization stratified by&#xD;
      recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency&#xD;
      Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a&#xD;
      stratification factor because it is expected that patients with difficulty swallowing&#xD;
      (dysphagia) after stroke that results in need for modifications to food/liquids will have a&#xD;
      different weight loss trajectory than patients who are able to safely consume a regular diet.&#xD;
      The follow-up duration will be 12 weeks for all subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor is blinded to study group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects achieving at least a 5% weight loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in blood pressure from baseline to 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in waist circumference from baseline to 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Body Mass Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in Body Mass Index from baseline to 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in modified Rankin scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in modified Rankin scale from baseline to 12 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Stroke</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Hemiparesis</condition>
  <arm_group>
    <arm_group_label>Diet Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The diet intervention is a partial meal replacement program using the commercially available OPTAVIA® Optimal Weight 4&amp;2&amp;1 Plan™. In the OPTAVIA program, subjects are asked to eat 6 times each day, once every 2 to 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Standard Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partial meal replacement program</intervention_name>
    <description>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.</description>
    <arm_group_label>Diet Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Counseling</intervention_name>
    <description>Participants will receive one 45-minute counseling session on a healthy diet</description>
    <arm_group_label>Enhanced Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute ischemic stroke within 90 days of randomization&#xD;
&#xD;
          2. Age &gt;=18&#xD;
&#xD;
          3. BMI 27-49.9 mg/kg2&#xD;
&#xD;
          4. Able to meet all nutritional and fluid needs by oral intake.&#xD;
&#xD;
          5. Ready to undergo behavioral change&#xD;
&#xD;
          6. Able and willing to provide written informed consent&#xD;
&#xD;
          7. Maximum weight &lt;=350 lbs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical contraindication to weight loss or diet, including the following: renal&#xD;
             disease requiring dialysis, taking lithium, or end stage liver or renal disease&#xD;
             considered incompatible with diet intervention by patient's personal healthcare&#xD;
             provider or the study PI&#xD;
&#xD;
          2. Enrollment in a conflicting clinical trial (defined as a trial with an intervention&#xD;
             known to affect weight or with an exclusion for participation in another trial)&#xD;
&#xD;
          3. Pregnancy or desire to become pregnant, or currently breastfeeding&#xD;
&#xD;
          4. High-risk of malnutrition using a standard screen&#xD;
&#xD;
          5. Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months&#xD;
             preceding screening)&#xD;
&#xD;
          6. Allergy to soy based food products&#xD;
&#xD;
          7. Require thickening of liquids due to dysphagia&#xD;
&#xD;
          8. Inability to communicate with study team&#xD;
&#xD;
          9. Inability to speak English&#xD;
&#xD;
         10. Irreversible medical conditions likely to affect short-term survival (predicted&#xD;
             survival of less than one year)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <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. 2023 May 15. doi: 10.1159/000530996. Online ahead of print.</citation>
    <PMID>37231793</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Jennifer Dearborn-Tomazos</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815214
org study id: 2018P000770
nct id: NCT03815214
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor is blinded to study group assignment
measure: Proportion of subjects achieving at least a 5% weight loss
time frame: 12 weeks
description: Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group
measure: Change in blood pressure
time frame: 12 weeks
description: Change in blood pressure from baseline to 12 weeks
measure: Change in Waist Circumference
time frame: 12 weeks
description: Change in waist circumference from baseline to 12 weeks
measure: Change in Body Mass Index
time frame: 12 weeks
description: Change in Body Mass Index from baseline to 12 weeks
measure: Change in modified Rankin scale
time frame: 12 weeks
description: Change in modified Rankin scale from baseline to 12 weeks
arm group label: Diet Intervention
arm group type: Experimental
description: 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.
arm group label: Enhanced Standard Care
arm group type: Placebo Comparator
description: The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.
intervention type: Behavioral
intervention name: Partial meal replacement program
description: 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.
arm group label: Diet Intervention
intervention type: Behavioral
intervention name: Dietary Counseling
description: Participants will receive one 45-minute counseling session on a healthy diet
arm group label: Enhanced Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
country: United States
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. 2023 May 15. doi: 10.1159/000530996. Online ahead of print.
PMID: 37231793
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Jennifer Dearborn-Tomazos
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Paresis
mesh term: Overweight
sharing ipd: No
ipd 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.