<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/NCT01671735</url>
  </required_header>
  <id_info>
    <org_study_id>RRP 12-440</org_study_id>
    <nct_id>NCT01671735</nct_id>
  </id_info>
  <brief_title>VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot</brief_title>
  <official_title>VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program&#xD;
      (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and&#xD;
      VA DPP-eligible VA MOVE! participants to identify baseline participant demographic&#xD;
      characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial&#xD;
      constructs such as social support; and self-regulation skills that predict 6-month weight&#xD;
      loss and program attendance. The data collected will contribute to our knowledge of&#xD;
      pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our&#xD;
      understanding of how different programs may impact weight loss, and to evidence-based&#xD;
      targeting in future clinical implementation projects. It will also provide baseline quality&#xD;
      of life data for use in a future cost-effectiveness analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Type 2 diabetes is a preventable disease. Multiple large scale randomized controlled trials&#xD;
      have shown that in people with impaired glucose tolerance, Type 2 diabetes can be prevented&#xD;
      with prevention lifestyle interventions that emphasize diet, exercise and weight loss. The&#xD;
      Diabetes Prevention Program (DPP) showed that lifestyle interventions can reduce the&#xD;
      incidence of type 2 diabetes by 58% in this high risk group. Little is known about the&#xD;
      incidence of pre-diabetes in the VA because routine screening for pre-diabetes is not an&#xD;
      established practice in the VA. With a few exceptions, lifestyle modification interventions&#xD;
      that target individuals with pre-diabetes and follow the Diabetes Prevention Program&#xD;
      curriculum are not available to Veterans in the VA. In order to address this gap in evidence&#xD;
      based clinical services, the National Center for Health Promotion and Disease Prevention&#xD;
      (NCP) has funded a VA Diabetes Prevention Program Demonstration Project (VA DPP) at 3 VA&#xD;
      Medical Centers (Baltimore, Minneapolis, and Greater Los Angeles). NCP has requested&#xD;
      assistance to conduct a more extensive implementation focused evaluation of VA DPP.&#xD;
&#xD;
      Methods Baseline survey data will be collected from 720 Veterans eligible for the VA DPP (360&#xD;
      in the VA DPP group, 360 in VA MOVE!) from 3 Medical Centers across the country. All&#xD;
      participants referred to the VA MOVE! program will be evaluated for VA DPP eligibility and&#xD;
      scheduled for a VA MOVE! orientation meeting. At that face-to-face orientation meeting, VA&#xD;
      DPP-eligible Veterans will be invited to complete the baseline survey after completing an&#xD;
      informed consent process and signing a written informed consent document. Consented Veterans&#xD;
      will be provided with a paper copy of the survey, a stamped return envelope addressed to the&#xD;
      Ann Arbor VA coordinating center and an incentive gift card or voucher. Instructions on the&#xD;
      survey will include a URL link to an online survey that can be used by Veterans who prefer to&#xD;
      answer the survey online as opposed to taking the paper survey. The survey will include a&#xD;
      unique participant code that will be used to match survey data with clinical and&#xD;
      administrative data by participant. The participant code will also be used to access the&#xD;
      online survey. There will be no other personal identifiers on the survey.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        1. To identify baseline participant demographic characteristics: attitudes and beliefs&#xD;
           about diet, exercise and weight loss: psychosocial constructs such as social support;&#xD;
           and self-regulation skills that predict 6-month weight loss and program attendance.&#xD;
&#xD;
        2. To collect baseline survey data on hypothesized modifiable mediators of program impact&#xD;
           on weight loss including outcome expectations, self-regulation, skill mastery,&#xD;
           willingness to self-monitor, self-efficacy for use in subsequent analyses after 6- and&#xD;
           12-month survey data and to collect quality of life data to be used in future&#xD;
           cost-effectiveness studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not considered a clinical trial because both treatment protocols have been approved as usual&#xD;
    care&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>VA DPP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-Diabetic Participants eligible for VA DPP receive a curriculum based life-style intervention program tailored off of the original DPP but in a group format</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VA DPP-eligible MOVE!</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pre-Diabetic participants who screen and are eligible for VA DPP but bc of class being filled - have been assigned to MOVE!</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>A clinical demonstration project funded by NCP will involve screening Veterans and enrolling veterans with pre-diabetes into the VA DPP program. This research project will recruit VA DPP eligible participants enrolled in the VA DPP program and Veterans enrolled in MOVE! that are VA DPP eligible as a comparison group. The research is not truly an intervention but similar to a program evaluation.</description>
    <arm_group_label>VA DPP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese Veterans who qualify for VA MOVE! who also have pre-diabetes by&#xD;
             the CDC&#xD;
&#xD;
          -  NDPRP criteria (fasting glucose of 100 to 125 mg/dl or Hgb A1C of 5.7 to 6.4 )&#xD;
&#xD;
          -  and who live within one hour of one of three VAMCs (Baltimore, Minneapolis and Greater&#xD;
             Los Angeles) will be eligible for the VA DPP program&#xD;
&#xD;
          -  Veterans who have been assigned to the VA DPP program or Veterans who have been&#xD;
             screened for the VA DPP program are eligible but classes have been filled and have&#xD;
             been assigned to VA MOVE! will be asked to consent to complete a survey questionnaire&#xD;
             at the time of enrollment&#xD;
&#xD;
          -  They will also be asked to consent for access to link their program data (such as&#xD;
             weight, BMI, visit attendance) to their survey data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with A1C of 6.5-6.9% although considered pre-diabetic by VA criteria, will be&#xD;
             excluded, as they are considered diabetic based upon ADA and NDPRP criteria for the VA&#xD;
             DPP clinical program&#xD;
&#xD;
          -  Similarly, patients who are being treated with metformin will be excluded, to avoid&#xD;
             confounding factors in the analysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline R Richardson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Ann Arbor Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48113-0170</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01671735
org study id: RRP 12-440
nct id: NCT01671735
lead sponsor: 
has dmc: No
This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program
      (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and
      VA DPP-eligible VA MOVE! participants to identify baseline participant demographic
      characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial
      constructs such as social support; and self-regulation skills that predict 6-month weight
      loss and program attendance. The data collected will contribute to our knowledge of
      pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our
      understanding of how different programs may impact weight loss, and to evidence-based
      targeting in future clinical implementation projects. It will also provide baseline quality
      of life data for use in a future cost-effectiveness analysis.
Background:

      Type 2 diabetes is a preventable disease. Multiple large scale randomized controlled trials
      have shown that in people with impaired glucose tolerance, Type 2 diabetes can be prevented
      with prevention lifestyle interventions that emphasize diet, exercise and weight loss. The
      Diabetes Prevention Program (DPP) showed that lifestyle interventions can reduce the
      incidence of type 2 diabetes by 58% in this high risk group. Little is known about the
      incidence of pre-diabetes in the VA because routine screening for pre-diabetes is not an
      established practice in the VA. With a few exceptions, lifestyle modification interventions
      that target individuals with pre-diabetes and follow the Diabetes Prevention Program
      curriculum are not available to Veterans in the VA. In order to address this gap in evidence
      based clinical services, the National Center for Health Promotion and Disease Prevention
      (NCP) has funded a VA Diabetes Prevention Program Demonstration Project (VA DPP) at 3 VA
      Medical Centers (Baltimore, Minneapolis, and Greater Los Angeles). NCP has requested
      assistance to conduct a more extensive implementation focused evaluation of VA DPP.

      Methods Baseline survey data will be collected from 720 Veterans eligible for the VA DPP (360
      in the VA DPP group, 360 in VA MOVE!) from 3 Medical Centers across the country. All
      participants referred to the VA MOVE! program will be evaluated for VA DPP eligibility and
      scheduled for a VA MOVE! orientation meeting. At that face-to-face orientation meeting, VA
      DPP-eligible Veterans will be invited to complete the baseline survey after completing an
      informed consent process and signing a written informed consent document. Consented Veterans
      will be provided with a paper copy of the survey, a stamped return envelope addressed to the
      Ann Arbor VA coordinating center and an incentive gift card or voucher. Instructions on the
      survey will include a URL link to an online survey that can be used by Veterans who prefer to
      answer the survey online as opposed to taking the paper survey. The survey will include a
      unique participant code that will be used to match survey data with clinical and
      administrative data by participant. The participant code will also be used to access the
      online survey. There will be no other personal identifiers on the survey.

      Objectives

        1. To identify baseline participant demographic characteristics: attitudes and beliefs
           about diet, exercise and weight loss: psychosocial constructs such as social support;
           and self-regulation skills that predict 6-month weight loss and program attendance.

        2. To collect baseline survey data on hypothesized modifiable mediators of program impact
           on weight loss including outcome expectations, self-regulation, skill mastery,
           willingness to self-monitor, self-efficacy for use in subsequent analyses after 6- and
           12-month survey data and to collect quality of life data to be used in future
           cost-effectiveness studies.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: weight loss
time frame: one year
arm group label: VA DPP
arm group type: Experimental
description: Pre-Diabetic Participants eligible for VA DPP receive a curriculum based life-style intervention program tailored off of the original DPP but in a group format
arm group label: VA DPP-eligible MOVE!
arm group type: No Intervention
description: Pre-Diabetic participants who screen and are eligible for VA DPP but bc of class being filled - have been assigned to MOVE!
intervention type: Other
intervention name: Survey
description: A clinical demonstration project funded by NCP will involve screening Veterans and enrolling veterans with pre-diabetes into the VA DPP program. This research project will recruit VA DPP eligible participants enrolled in the VA DPP program and Veterans enrolled in MOVE! that are VA DPP eligible as a comparison group. The research is not truly an intervention but similar to a program evaluation.
arm group label: VA DPP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Caroline R Richardson, MD
role: Principal Investigator
affiliation: VA Ann Arbor Healthcare System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State