xml: <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/NCT06001801</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00227197</org_study_id>
      <nct_id>NCT06001801</nct_id>
    </id_info>
    <brief_title>The Inspiring Action to Prevent Diabetes Intervention</brief_title>
    <acronym>INSPIRA</acronym>
    <official_title>Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Diabetes Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research is studying how to help increase uptake of and engagement in formal Diabetes&#xD;
        Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce&#xD;
        risk of getting diabetes.&#xD;
  &#xD;
        This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP&#xD;
        program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program&#xD;
        includes getting matched with someone else in the program to provide each other support along&#xD;
        with a chance to earn healthy food vouchers.&#xD;
  &#xD;
        Eligible participants will be randomized to one of the two groups and be asked to participate&#xD;
        for approximately 6 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <phase>N/A</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in weight</measure>
      <time_frame>baseline, 6 months</time_frame>
      <description>Weight will be measured in pounds.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in hemoglobin A1c</measure>
      <time_frame>baseline, 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in waist circumference</measure>
      <time_frame>baseline, 6 months</time_frame>
      <description>This will be measured in centimeters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of group sessions attended by participants</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in reported diet quality</measure>
      <time_frame>baseline, 6 months</time_frame>
      <description>measured by comparing baseline and six month survey responses</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">142</enrollment>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>Diabetes Prevention Program (DPP) (usual care)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>DPP plus the INSPIRA intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will include the DPP plus additional interventions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Diabetes Prevention Program</intervention_name>
      <description>The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.&#xD;
  This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.&#xD;
  Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.&#xD;
  Participation in this project should last approximately 6-months.</description>
      <arm_group_label>DPP plus the INSPIRA intervention</arm_group_label>
      <arm_group_label>Diabetes Prevention Program (DPP) (usual care)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>INSPIRA</intervention_name>
      <description>This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session.&#xD;
  CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions.&#xD;
  Participation in this project should last approximately 6-months.</description>
      <arm_group_label>DPP plus the INSPIRA intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English or Spanish-speaking&#xD;
  &#xD;
            -  Body Mass Index (BMI) &gt; 24.9 kilograms/meters squared (kg/m2)&#xD;
  &#xD;
            -  The most recent A1c test, completed in 60 days or fewer prior to enrollment, is&#xD;
               5.7%-6.4%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with schizophrenia&#xD;
  &#xD;
            -  Active alcohol or other drug abuse&#xD;
  &#xD;
            -  Are pregnant or planning pregnancy in next 6 months&#xD;
  &#xD;
            -  Will not be in local area in six months&#xD;
  &#xD;
            -  Will not be able to attend sessions, in-person or remotely, for three more weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mary Ellen M Heisler, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shelley Stoll, MPH</last_name>
      <phone>734-232-0697</phone>
      <email>scstoll@med.umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Community Health and Social Services Center, Incorporated</name>
        <address>
          <city>Detroit</city>
          <state>Michigan</state>
          <zip>48209</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shelley Stoll, MPH</last_name>
        <phone>734-232-0697</phone>
        <email>scstoll@med.umich.edu</email>
      </contact>
      <investigator>
        <last_name>Mary Ellen M Heisler, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Mary Ellen Michele Heisler</investigator_full_name>
      <investigator_title>Professor of Internal Medicine</investigator_title>
    </responsible_party>
    <keyword>Diabetes Prevention Program</keyword>
    <keyword>Behaviors</keyword>
    <keyword>Weight loss</keyword>
    <keyword>Healthy lifestyle changes</keyword>
    <keyword>Peer Partner</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001801
  org study id: HUM00227197
  nct id: NCT06001801
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This research is studying how to help increase uptake of and engagement in formal Diabetes
        Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce
        risk of getting diabetes.
  
        This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP
        program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program
        includes getting matched with someone else in the program to provide each other support along
        with a chance to earn healthy food vouchers.
  
        Eligible participants will be randomized to one of the two groups and be asked to participate
        for approximately 6 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in weight
  time frame: baseline, 6 months
  description: Weight will be measured in pounds.
  measure: Change in hemoglobin A1c
  time frame: baseline, 6 months
  measure: Change in waist circumference
  time frame: baseline, 6 months
  description: This will be measured in centimeters.
  measure: Number of group sessions attended by participants
  time frame: 6 months
  measure: Change in reported diet quality
  time frame: baseline, 6 months
  description: measured by comparing baseline and six month survey responses
  arm group label: Diabetes Prevention Program (DPP) (usual care)
  arm group type: Active Comparator
  arm group label: DPP plus the INSPIRA intervention
  arm group type: Experimental
  description: This arm will include the DPP plus additional interventions.
  intervention type: Behavioral
  intervention name: Diabetes Prevention Program
  description: The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.
  This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.
  Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.
  Participation in this project should last approximately 6-months.
  arm group label: DPP plus the INSPIRA intervention
  arm group label: Diabetes Prevention Program (DPP) (usual care)
  intervention type: Behavioral
  intervention name: INSPIRA
  description: This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session.
  CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions.
  Participation in this project should last approximately 6-months.
  arm group label: DPP plus the INSPIRA intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mary Ellen M Heisler, MD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Shelley Stoll, MPH
  phone: 734-232-0697
  email: scstoll@med.umich.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Mary Ellen Michele Heisler
  investigator title: Professor of Internal Medicine
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  sharing ipd: No