<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/NCT01682954</url>
  </required_header>
  <id_info>
    <org_study_id>2012H0149</org_study_id>
    <secondary_id>1R34DK093907</secondary_id>
    <nct_id>NCT01682954</nct_id>
  </id_info>
  <brief_title>Evaluation of a Lifestyle Intervention for Employees With Prediabetes</brief_title>
  <official_title>Evaluation of a Lifestyle Intervention for Employees With Prediabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for&#xD;
      diabetes prevention among employees with prediabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The lifestyle intervention includes a 16-week group-based program which targets weight&#xD;
      reduction through the adoption of a lower fat diet and greater physical activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>4 months</time_frame>
    <description>Change in body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>7 Months</time_frame>
    <description>Change in body weight</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Prediabetes</condition>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes Prevention Program lifestyle intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care from primary care physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle counseling</intervention_name>
    <description>16-week nutrition, physical activity and behavioral intervention</description>
    <arm_group_label>Lifestyle counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  overweight or obese&#xD;
&#xD;
          -  prediabetes with elevated glucose value&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent cardiovascular event&#xD;
&#xD;
          -  use of corticosteroids&#xD;
&#xD;
          -  concurrent participation in a structured weight loss program&#xD;
&#xD;
          -  pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>October 16, 2014</results_first_submitted>
  <results_first_submitted_qc>October 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 23, 2014</results_first_posted>
  <last_update_submitted>October 22, 2014</last_update_submitted>
  <last_update_submitted_qc>October 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Carla Miller</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>lifestyle risk reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lifestyle Counseling</title>
          <description>Diabetes Prevention Program lifestyle intervention&#xD;
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care from primary care physician</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lifestyle Counseling</title>
          <description>Diabetes Prevention Program lifestyle intervention&#xD;
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care from primary care physician</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.75" spread="9.49"/>
                    <measurement group_id="B2" value="50.55" spread="7.99"/>
                    <measurement group_id="B3" value="50.65" spread="8.73"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Body Weight</title>
        <description>Change in body weight</description>
        <time_frame>4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Counseling</title>
            <description>Diabetes Prevention Program lifestyle intervention&#xD;
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care from primary care physician</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight</title>
          <description>Change in body weight</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.12" spread="0.63"/>
                    <measurement group_id="O2" value="-0.37" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight</title>
        <description>Change in body weight</description>
        <time_frame>7 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Counseling</title>
            <description>Diabetes Prevention Program lifestyle intervention&#xD;
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care from primary care physician</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight</title>
          <description>Change in body weight</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.86" spread="0.62"/>
                    <measurement group_id="O2" value="-0.35" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Lifestyle Counseling</title>
          <description>Diabetes Prevention Program lifestyle intervention&#xD;
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care from primary care physician</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Carla Miller</name_or_title>
      <organization>Ohio State University</organization>
      <phone>614-292-1391</phone>
      <email>miller.4453@osu.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/NCT01682954
org study id: 2012H0149
secondary id: 1R34DK093907
nct id: NCT01682954
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for
      diabetes prevention among employees with prediabetes.
The lifestyle intervention includes a 16-week group-based program which targets weight
      reduction through the adoption of a lower fat diet and greater physical activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Body Weight
time frame: 4 months
description: Change in body weight
measure: Body Weight
time frame: 7 Months
description: Change in body weight
arm group label: Lifestyle counseling
arm group type: Experimental
description: Diabetes Prevention Program lifestyle intervention
arm group label: Usual Care
arm group type: No Intervention
description: Usual care from primary care physician
intervention type: Behavioral
intervention name: Lifestyle counseling
description: 16-week nutrition, physical activity and behavioral intervention
arm group label: Lifestyle counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Carla Miller, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Carla Miller
investigator title: Associate Professor
mesh term: Overweight
mesh term: Prediabetic State
mesh term: Glucose Intolerance
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 