<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/NCT03766256</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#18-001058</org_study_id>
    <nct_id>NCT03766256</nct_id>
  </id_info>
  <brief_title>Shared Decision Making in Diabetes Prevention for Women With a History of GDM</brief_title>
  <official_title>Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes.&#xD;
      Lifestyle change and metformin are equally effective in preventing diabetes in patients with&#xD;
      a history of GDM, so these women should choose a strategy based on their preferences and&#xD;
      values, which may vary by race/ethnicity. This proposal will engage 32 women in shared&#xD;
      decision making about diabetes prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and&#xD;
      metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has&#xD;
      been minimal. The research team is implementing a shared decision-making (SDM) intervention&#xD;
      for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney&#xD;
      Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed&#xD;
      Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in&#xD;
      evidence-based diabetes prevention using an SDM framework. The research team reached the&#xD;
      recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the&#xD;
      number of projected participants (n=515), including 56% from racial/ethnic minority groups.&#xD;
      PRIDE has been highly successful in treatment engagement, as 85% of participants chose either&#xD;
      lifestyle change or metformin. Furthermore, among patients who have reached 12-month&#xD;
      follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2&#xD;
      lbs. vs. -0.29 lbs., p&lt;0.001).&#xD;
&#xD;
      PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history&#xD;
      of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among&#xD;
      minority women and a history of a GDM diagnosis is one of the most significant risk factors&#xD;
      for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold.&#xD;
      The research team is planning to pilot an SDM intervention for women with a history of GDM.&#xD;
      This project would advance a patient-centered approach to increase uptake of both&#xD;
      evidence-based diabetes prevention strategies among the subgroup of minority women at the&#xD;
      highest risk of progression to T2DM.&#xD;
&#xD;
      In the proposed project, the research team plans to enroll women with a history of GDM in a&#xD;
      pilot study, tracking their choice of diabetes prevention strategy and their weight change&#xD;
      over time. Importantly, the pilot will enable the research team to estimate the sample size&#xD;
      for a future, multi-center study to engage women with a history of GDM in SDM for diabetes&#xD;
      prevention. The project's specific aim is as follows:&#xD;
&#xD;
      In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a&#xD;
      history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes,&#xD;
      with a sample divided equally between whites, African Americans, Latinas and Asian Americans&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">December 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Choice of evidence-based diabetes prevention (lifestyle change or metformin)</measure>
    <time_frame>2 weeks</time_frame>
    <description>One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>9 months</time_frame>
    <description>Change of weight as measured in the EHR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>9 months</time_frame>
    <description>Change in systolic blood pressure as measured in the EHR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional conflict</measure>
    <time_frame>2 weeks</time_frame>
    <description>Three collaboRATE items that measure decisional conflict</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Shared decision-making with pharmacists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Shared decision-making with pharmacists</intervention_name>
    <description>Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.</description>
    <arm_group_label>Shared decision-making with pharmacists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese (BMI &gt;25 or &gt;23 if Asian American)&#xD;
&#xD;
          -  at least 6 weeks post-partum&#xD;
&#xD;
          -  have a history of gestational diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant,&#xD;
&#xD;
          -  not a UCLA Health patient&#xD;
&#xD;
          -  any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values,&#xD;
             or taking any antiglycemic medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Toluca Lake Health Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>100 Medical Plaza Primary Care Suites 455 &amp; 490</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine Women's Health Clinic Suites 250 &amp; 290</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Internal Medicine Family Westwood Suite 465</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Internal Medicine Geriatrics Suite 365 &amp; 420</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPN Brentwood</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPN West Washington Internal Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Palisades</name>
      <address>
        <city>Pacific Palisades</city>
        <state>California</state>
        <zip>90272</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>12th Street Clinic</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Office</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPN Santa Monica 15th Street Family Medicine Practice</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPN/Santa Monica Parkside</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Moica Bay Physicians/20th Street 10th Floor</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Bay Physicians Plaza</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Bay Physicians/20th Street 3rd Floor</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Monica Internal Medicine</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Family Health Clinic</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Moica Bay Physicians Ocean Park</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jack H. Skirball Health Center</name>
      <address>
        <city>Woodland Hills</city>
        <state>California</state>
        <zip>91364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPN Woodland Hills Practice</name>
      <address>
        <city>Woodland Hills</city>
        <state>California</state>
        <zip>91367</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Kenrik Duru</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT03766256
org study id: IRB#18-001058
nct id: NCT03766256
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes.
      Lifestyle change and metformin are equally effective in preventing diabetes in patients with
      a history of GDM, so these women should choose a strategy based on their preferences and
      values, which may vary by race/ethnicity. This proposal will engage 32 women in shared
      decision making about diabetes prevention.
The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and
      metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has
      been minimal. The research team is implementing a shared decision-making (SDM) intervention
      for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney
      Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed
      Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in
      evidence-based diabetes prevention using an SDM framework. The research team reached the
      recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the
      number of projected participants (n=515), including 56% from racial/ethnic minority groups.
      PRIDE has been highly successful in treatment engagement, as 85% of participants chose either
      lifestyle change or metformin. Furthermore, among patients who have reached 12-month
      follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2
      lbs. vs. -0.29 lbs., p<0.001).

      PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history
      of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among
      minority women and a history of a GDM diagnosis is one of the most significant risk factors
      for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold.
      The research team is planning to pilot an SDM intervention for women with a history of GDM.
      This project would advance a patient-centered approach to increase uptake of both
      evidence-based diabetes prevention strategies among the subgroup of minority women at the
      highest risk of progression to T2DM.

      In the proposed project, the research team plans to enroll women with a history of GDM in a
      pilot study, tracking their choice of diabetes prevention strategy and their weight change
      over time. Importantly, the pilot will enable the research team to estimate the sample size
      for a future, multi-center study to engage women with a history of GDM in SDM for diabetes
      prevention. The project's specific aim is as follows:

      In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a
      history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes,
      with a sample divided equally between whites, African Americans, Latinas and Asian Americans
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Choice of evidence-based diabetes prevention (lifestyle change or metformin)
time frame: 2 weeks
description: One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.
measure: Weight change
time frame: 9 months
description: Change of weight as measured in the EHR
measure: Systolic blood pressure
time frame: 9 months
description: Change in systolic blood pressure as measured in the EHR
measure: Decisional conflict
time frame: 2 weeks
description: Three collaboRATE items that measure decisional conflict
arm group label: Shared decision-making with pharmacists
arm group type: Experimental
description: Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool
intervention type: Behavioral
intervention name: Shared decision-making with pharmacists
description: Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
arm group label: Shared decision-making with pharmacists
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
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country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Kenrik Duru
investigator title: Professor of Medicine
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus