<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/NCT03258723</url>
  </required_header>
  <id_info>
    <org_study_id>2000020105</org_study_id>
    <secondary_id>1K12HL138037-01</secondary_id>
    <secondary_id>1U54MD010711-01</secondary_id>
    <nct_id>NCT03258723</nct_id>
  </id_info>
  <brief_title>Diabetes Prevention With Lifestyle Intervention and Metformin Escalation</brief_title>
  <acronym>LIME</acronym>
  <official_title>Diabetes Prevention With Lifestyle Intervention and Metformin Escalation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk&#xD;
      pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.&#xD;
&#xD;
      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle&#xD;
      intervention, with escalation to Metformin therapy will lower the incidence of diabetes among&#xD;
      the highest risk pre-diabetic individuals of Caribbean-descent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to conduct a pragmatic trial that tests the effectiveness of&#xD;
      lifestyle modification and Metformin use in minority populations. Our study population is&#xD;
      Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have&#xD;
      five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1,&#xD;
      Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators'&#xD;
      strong research network in these locations, and to enable us to address diabetes disparities&#xD;
      due to geographic differences. The investigators will first modify an established lifestyle&#xD;
      modification workshop series developed by the East Harlem Partnership for Diabetes Prevention&#xD;
      (EHPDP) for use in the community, 10to target the population at the involved clinical sites.&#xD;
      The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the&#xD;
      highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who&#xD;
      remain morbidly obese.&#xD;
&#xD;
      The investigators will leverage our existing robust research infrastructure and network at&#xD;
      the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and&#xD;
      now the Yale Transdisciplinary Collaborative center for Health Disparities focused on&#xD;
      Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD&#xD;
      (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean.&#xD;
      The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands&#xD;
      to include New York and New Jersey and focuses on diabetes and hypertension. The&#xD;
      investigators' network includes community advisory boards as well as policy delegations that&#xD;
      are well suited to inform this project and its expansion into routine healthcare practice and&#xD;
      policy.&#xD;
&#xD;
      The control arm of this study was never activated due to COVID-19 restrictions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 led to changes in study design and an early end to data collection.&#xD;
  </why_stopped>
  <start_date type="Actual">July 30, 2018</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patient Recruitment:&#xD;
The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics.&#xD;
Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS).&#xD;
ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Hemoglobin A1C (HbA1C) test was assessed via clinical tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Weight (kg)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Weight in kilograms (kg) assessed via clinical tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Systolic blood pressure assessed via clinical tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diastolic Blood Pressure</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Diastolic blood pressure assessed via clinical tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Risk Score</measure>
    <time_frame>6 months</time_frame>
    <description>The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy Score - Personal Control Scale</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy Score - Worry Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Level.</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fruit and Vegetable Intake (Total Servings)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Total mean servings per day of fruit and vegetables self report via electronic survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Highest risk pre-diabetic patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Glucophage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;25 or WC&gt;88/102cm&#xD;
&#xD;
          -  No history of type I or type II diabetes or gestational diabetes&#xD;
&#xD;
          -  Not on blood sugar altering medication&#xD;
&#xD;
          -  Ability to attend weekly sessions&#xD;
&#xD;
          -  HbA1c 6-6.4%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  eGFR&lt;45 mL/min/1.73 m2&#xD;
&#xD;
          -  Prescribed Metformin and randomized to the control arm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcella Nunez-Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics</name>
      <address>
        <city>Bridgetown</city>
        <country>Barbados</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine Clinic at the University of Puerto Rico Hospital</name>
      <address>
        <city>Carolina</city>
        <zip>00984</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Regional Health Authority, La Romaine Health Center</name>
      <address>
        <city>San Fernando</city>
        <country>Trinidad and Tobago</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ministry of Health Clinics</name>
      <address>
        <city>Charlotte Amalie</city>
        <country>Virgin Islands (U.S.)</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Barbados</country>
    <country>Puerto Rico</country>
    <country>Trinidad and Tobago</country>
    <country>Virgin Islands (U.S.)</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>December 1, 2022</results_first_submitted>
  <results_first_submitted_qc>December 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2022</results_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03258723/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 17, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03258723/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 211 participants agreed to be a part of the study, 114 participants attended at least 1 workshop and are those considered &quot;enrolled&quot;.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Month Follow up</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 Month Follow up</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>COVID Interruption of study</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="114"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.3" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African or Caribbean</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino or Puerto Rican</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed or multi-racial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown/Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <population>1 participant missing education information.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Hemoglobin A1c (HbA1c)</title>
        <description>Hemoglobin A1C (HbA1C) test was assessed via clinical tests.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>All participants with valid data on matched cases at baseline and 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hemoglobin A1c (HbA1c)</title>
          <description>Hemoglobin A1C (HbA1C) test was assessed via clinical tests.</description>
          <population>All participants with valid data on matched cases at baseline and 12 months.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.19" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Weight (kg)</title>
        <description>Weight in kilograms (kg) assessed via clinical tests.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data that could be matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight (kg)</title>
          <description>Weight in kilograms (kg) assessed via clinical tests.</description>
          <population>Participants with valid data that could be matched from baseline to 6 months.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.66" spread="16.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.00" spread="16.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure</title>
        <description>Systolic blood pressure assessed via clinical tests.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure</title>
          <description>Systolic blood pressure assessed via clinical tests.</description>
          <population>Participants with valid data matched from baseline to 6 months.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.93" spread="20.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.64" spread="18.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1809</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diastolic Blood Pressure</title>
        <description>Diastolic blood pressure assessed via clinical tests.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure</title>
          <description>Diastolic blood pressure assessed via clinical tests.</description>
          <population>Participants with valid data matched from baseline to 6 months.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.86" spread="11.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.54" spread="10.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0973</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Risk Score</title>
        <description>The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.</description>
        <time_frame>6 months</time_frame>
        <population>These data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Risk Score</title>
          <description>The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.</description>
          <population>These data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-Efficacy Score - Personal Control Scale</title>
        <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Matched cases with valid data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-Efficacy Score - Personal Control Scale</title>
          <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
          <population>Matched cases with valid data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within subject change on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1992</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-Efficacy Score - Worry Scale</title>
        <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
        <time_frame>6 months</time_frame>
        <population>Matched cases with valid data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-Efficacy Score - Worry Scale</title>
          <description>The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.</description>
          <population>Matched cases with valid data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.88" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within subject change on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7017</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Activity Level.</title>
        <description>Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data that could be matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Activity Level.</title>
          <description>Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire</description>
          <population>Participants with valid data that could be matched from baseline to 6 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <title>Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases in low activity group at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1573</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases in medium activity group at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4328</p_value>
            <method>McNemar</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases in high activity group at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6698</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fruit and Vegetable Intake (Total Servings)</title>
        <description>Total mean servings per day of fruit and vegetables self report via electronic survey.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data that could be matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fruit and Vegetable Intake (Total Servings)</title>
          <description>Total mean servings per day of fruit and vegetables self report via electronic survey.</description>
          <population>Participants with valid data that could be matched from baseline to 6 months.</population>
          <units>daily servings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5271</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)</title>
        <description>Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with valid data that could be matched from baseline to 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)</title>
          <description>Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.</description>
          <population>Participants with valid data that could be matched from baseline to 6 months.</population>
          <units>teaspoons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.30" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.83" spread="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Within group change from baseline assessed on matched cases.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Highest risk pre-diabetic patients&#xD;
Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.&#xD;
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.&#xD;
Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="114"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marcella Nunez-Smith, MD, MHS</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>(203) 785-6454</phone>
      <email>marcella.nunez-smith@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03258723
org study id: 2000020105
secondary id: 1K12HL138037-01
secondary id: 1U54MD010711-01
nct id: NCT03258723
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk
      pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.

      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle
      intervention, with escalation to Metformin therapy will lower the incidence of diabetes among
      the highest risk pre-diabetic individuals of Caribbean-descent.
The investigators propose to conduct a pragmatic trial that tests the effectiveness of
      lifestyle modification and Metformin use in minority populations. Our study population is
      Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have
      five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1,
      Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators'
      strong research network in these locations, and to enable us to address diabetes disparities
      due to geographic differences. The investigators will first modify an established lifestyle
      modification workshop series developed by the East Harlem Partnership for Diabetes Prevention
      (EHPDP) for use in the community, 10to target the population at the involved clinical sites.
      The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the
      highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who
      remain morbidly obese.

      The investigators will leverage our existing robust research infrastructure and network at
      the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and
      now the Yale Transdisciplinary Collaborative center for Health Disparities focused on
      Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD
      (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean.
      The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands
      to include New York and New Jersey and focuses on diabetes and hypertension. The
      investigators' network includes community advisory boards as well as policy delegations that
      are well suited to inform this project and its expansion into routine healthcare practice and
      policy.

      The control arm of this study was never activated due to COVID-19 restrictions.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patient Recruitment:
The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics.
Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS).
ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Hemoglobin A1c (HbA1c)
time frame: Baseline and 12 months
description: Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
measure: Change in Weight (kg)
time frame: Baseline and 6 months
description: Weight in kilograms (kg) assessed via clinical tests.
measure: Change in Systolic Blood Pressure
time frame: Baseline and 6 months
description: Systolic blood pressure assessed via clinical tests.
measure: Change in Diastolic Blood Pressure
time frame: Baseline and 6 months
description: Diastolic blood pressure assessed via clinical tests.
measure: Diabetes Risk Score
time frame: 6 months
description: The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.
measure: Change in Self-Efficacy Score - Personal Control Scale
time frame: Baseline and 6 months
description: The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
measure: Change in Self-Efficacy Score - Worry Scale
time frame: 6 months
description: The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
measure: Change in Physical Activity Level.
time frame: Baseline and 6 months
description: Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
measure: Change in Fruit and Vegetable Intake (Total Servings)
time frame: Baseline and 6 months
description: Total mean servings per day of fruit and vegetables self report via electronic survey.
measure: Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)
time frame: Baseline and 6 months
description: Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.
arm group label: Intervention
arm group type: Experimental
description: Highest risk pre-diabetic patients
arm group label: Control
arm group type: No Intervention
description: Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups.
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.
The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.
arm group label: Intervention
intervention type: Drug
intervention name: Metformin
description: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
arm group label: Intervention
other name: Glucophage
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Marcella Nunez-Smith, MD
role: Principal Investigator
affiliation: Yale University
facility: 
facility: 
facility: 
facility: 
country: Barbados
country: Puerto Rico
country: Trinidad and Tobago
country: Virgin Islands (U.S.)
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Metformin
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 