<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/NCT03283657</url>
  </required_header>
  <id_info>
    <org_study_id>STU00204220</org_study_id>
    <secondary_id>R34DK113541</secondary_id>
    <nct_id>NCT03283657</nct_id>
  </id_info>
  <brief_title>Diabetes Risk Education and Communication Trial</brief_title>
  <acronym>DiRECT</acronym>
  <official_title>Diabetes Risk Education and Communication Trial (DiRECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern 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>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A large body of research has demonstrated that intensive lifestyle interventions and&#xD;
      metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet&#xD;
      neither treatment is routinely used in practice. This pilot study will develop and evaluate&#xD;
      the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates&#xD;
      information about diabetes risk and treatment options for preventing diabetes among primary&#xD;
      care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project&#xD;
      has large potential to impact public health by developing a scalable intervention to promote&#xD;
      the use of evidence-based treatments that lower diabetes risk in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Landmark clinical trials have found that intensive lifestyle interventions (ILI) and&#xD;
      metformin are safe and effective treatment options for preventing diabetes among adults with&#xD;
      prediabetes and overweight/obesity. Despite being included in expert clinical guidelines,&#xD;
      these treatments are rarely used in practice and little existing research has focused on&#xD;
      approaches for promoting their use.&#xD;
&#xD;
      This novel intervention, delivered by medical assistants before patients' routinely scheduled&#xD;
      office visits, consists of the following 3 components intended to promote initiation of ILI&#xD;
      and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options&#xD;
      for preventing diabetes; 2) a &quot;think aloud&quot; exercise; and 3) formulating a preliminary&#xD;
      treatment plan. Previous studies report that medical assistants can improve uptake of some&#xD;
      preventive health services in primary care, which may also be true for ILI and metformin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 17, 2019</completion_date>
  <primary_completion_date type="Actual">March 17, 2019</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin</measure>
    <time_frame>3 months</time_frame>
    <description>The number of participants that initiate ILI, Metformin, or both treatments at follow-up is the primary outcome of the pilot trial, which will be assessed in the following ways. Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose. Attendance logs will be used to confirm whether participants attended at least 1 ILI session. Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment. Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment. Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Body Weight</condition>
  <condition>Body Weight Changes</condition>
  <arm_group>
    <arm_group_label>DiRECT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DiRECT consists of the following components that will be delivered by medical assistants before patients' routinely scheduled office visits: 1) a prediabetes decision aid focused on type 2 diabetes (T2D) risk and treatment options for preventing T2D; 2) a 'think aloud' exercise; and 3) formulating a preliminary treatment plan for T2D prevention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DiRECT</intervention_name>
    <description>DiRECT participants will meet with a medical assistant (MA) before a routinely scheduled office and formulate a preliminary treatment plan for T2D prevention. Participants will attend their scheduled physician visit, during which they may make a definitive treatment plan to initiate metformin and/or ILI.</description>
    <arm_group_label>DiRECT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care (UC)</intervention_name>
    <description>Standard care with routine medical care.</description>
    <arm_group_label>Usual Care (UC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight or obesity&#xD;
&#xD;
          -  documentation of prediabetes in medical chart or&#xD;
&#xD;
          -  A1c 5.7-6.4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18; individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Patient's primary care physician did not provide permission to participate in the&#xD;
             study&#xD;
&#xD;
          -  Pregnancy status: current or planned pregnancy during study period&#xD;
&#xD;
          -  Serum creatinine &gt;1.4mg/dL in women and &gt;1.5mg/dL in men&#xD;
&#xD;
          -  Patients that are blind, deaf, or otherwise unable to review study materials&#xD;
&#xD;
          -  Prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication&#xD;
&#xD;
          -  Diagnosis of post-surgical hypoinsulinemia&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  Uncontrolled hypertension (≥160/100 mm Hg)&#xD;
&#xD;
          -  No office visit in past 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew J O'Brien</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Matthew J O'Brien</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283657
org study id: STU00204220
secondary id: R34DK113541
nct id: NCT03283657
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A large body of research has demonstrated that intensive lifestyle interventions and
      metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet
      neither treatment is routinely used in practice. This pilot study will develop and evaluate
      the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates
      information about diabetes risk and treatment options for preventing diabetes among primary
      care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project
      has large potential to impact public health by developing a scalable intervention to promote
      the use of evidence-based treatments that lower diabetes risk in this population.
Landmark clinical trials have found that intensive lifestyle interventions (ILI) and
      metformin are safe and effective treatment options for preventing diabetes among adults with
      prediabetes and overweight/obesity. Despite being included in expert clinical guidelines,
      these treatments are rarely used in practice and little existing research has focused on
      approaches for promoting their use.

      This novel intervention, delivered by medical assistants before patients' routinely scheduled
      office visits, consists of the following 3 components intended to promote initiation of ILI
      and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options
      for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary
      treatment plan. Previous studies report that medical assistants can improve uptake of some
      preventive health services in primary care, which may also be true for ILI and metformin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
time frame: 3 months
description: The number of participants that initiate ILI, Metformin, or both treatments at follow-up is the primary outcome of the pilot trial, which will be assessed in the following ways. Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose. Attendance logs will be used to confirm whether participants attended at least 1 ILI session. Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment. Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment. Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.
arm group label: DiRECT
arm group type: Experimental
description: DiRECT consists of the following components that will be delivered by medical assistants before patients' routinely scheduled office visits: 1) a prediabetes decision aid focused on type 2 diabetes (T2D) risk and treatment options for preventing T2D; 2) a 'think aloud' exercise; and 3) formulating a preliminary treatment plan for T2D prevention.
arm group label: Usual Care (UC)
arm group type: Active Comparator
description: Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.
intervention type: Behavioral
intervention name: DiRECT
description: DiRECT participants will meet with a medical assistant (MA) before a routinely scheduled office and formulate a preliminary treatment plan for T2D prevention. Participants will attend their scheduled physician visit, during which they may make a definitive treatment plan to initiate metformin and/or ILI.
arm group label: DiRECT
intervention type: Behavioral
intervention name: Usual care (UC)
description: Standard care with routine medical care.
arm group label: Usual Care (UC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew J O'Brien
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Matthew J O'Brien
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Body Weight
mesh term: Body Weight Changes
sharing ipd: No