<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/NCT03240289</url>
  </required_header>
  <id_info>
    <org_study_id>STU00084353</org_study_id>
    <nct_id>NCT03240289</nct_id>
  </id_info>
  <brief_title>Texting for Diabetes Success in Pregnancy</brief_title>
  <official_title>Use of Text Messaging to Reduce Barriers to Self-care for Low-income Pregnant Women With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Diabetes during pregnancy can be a challenging circumstance requiring extensive patient&#xD;
      learning and self-care. The purpose of this study is to develop and pilot test a&#xD;
      patient-centered diabetes education and self-care tool using text messaging to provide&#xD;
      supportive messaging and education to underserved women with a pregnancy complicated by&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low-income, pregnant women in the Chicago area are frequently affected by obesity or&#xD;
      diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal&#xD;
      self-care during pregnancy. This load of information poses a significant burden, particularly&#xD;
      for women with additional socioeconomic barriers to self-care. Preliminary work suggests&#xD;
      patients must overcome a number of social, psychological, and knowledge-based barriers to&#xD;
      achieve successful diabetic control in pregnancy.&#xD;
&#xD;
      This project involves development and preliminary evaluation of a patient-centered education&#xD;
      and self-care tool for use with women whose pregnancies are complicated by diabetes. The&#xD;
      study begins with development of a text messaging curriculum to provide motivational and&#xD;
      educational support. We will use a one-way, non-interactive text-based educational platform&#xD;
      to provide supportive and educational messages to a cohort of 40 women with diabetes. Women&#xD;
      receive 3-5 text messages per week until delivery. The goal is to develop a program that can&#xD;
      be expanded to a clinical trial in which perinatal outcomes are assessed.&#xD;
&#xD;
      The primary outcome is patient satisfaction and opinions about the texting program, as&#xD;
      measured via a qualitative interview upon study completion. Participants underwent an&#xD;
      enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes&#xD;
      knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one&#xD;
      interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up&#xD;
      surveys and an exit interview elicited information about their opinions of the texting&#xD;
      program. Additional goals included determining feasibility for future expansion as a trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
    <intervention_model_description>Single arm feasibility and pilot testing study of a curriculum</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction and feedback</measure>
    <time_frame>Up to 42 weeks</time_frame>
    <description>A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)</measure>
    <time_frame>Up to 42 weeks</time_frame>
    <description>Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers and facilitators of diabetes self-management</measure>
    <time_frame>Study enrollment</time_frame>
    <description>Qualitative interview of patient experiences regarding having diabetes during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study feasibility (as measured by number of participants retained in the study)</measure>
    <time_frame>Up to 42 weeks</time_frame>
    <description>Ability to recruit and retain participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)</measure>
    <time_frame>Up to 42 weeks</time_frame>
    <description>Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Pregnancy in Diabetics</condition>
  <arm_group>
    <arm_group_label>Texting</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Texting group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Texting group</intervention_name>
    <description>Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.</description>
    <arm_group_label>Texting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes&#xD;
             mellitus&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Access to a phone that can receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational age greater than 30 weeks&#xD;
&#xD;
          -  Women not meeting the above inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa A Simon, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Lynn M Yee</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, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03240289
org study id: STU00084353
nct id: NCT03240289
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient
      learning and self-care. The purpose of this study is to develop and pilot test a
      patient-centered diabetes education and self-care tool using text messaging to provide
      supportive messaging and education to underserved women with a pregnancy complicated by
      diabetes.
Low-income, pregnant women in the Chicago area are frequently affected by obesity or
      diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal
      self-care during pregnancy. This load of information poses a significant burden, particularly
      for women with additional socioeconomic barriers to self-care. Preliminary work suggests
      patients must overcome a number of social, psychological, and knowledge-based barriers to
      achieve successful diabetic control in pregnancy.

      This project involves development and preliminary evaluation of a patient-centered education
      and self-care tool for use with women whose pregnancies are complicated by diabetes. The
      study begins with development of a text messaging curriculum to provide motivational and
      educational support. We will use a one-way, non-interactive text-based educational platform
      to provide supportive and educational messages to a cohort of 40 women with diabetes. Women
      receive 3-5 text messages per week until delivery. The goal is to develop a program that can
      be expanded to a clinical trial in which perinatal outcomes are assessed.

      The primary outcome is patient satisfaction and opinions about the texting program, as
      measured via a qualitative interview upon study completion. Participants underwent an
      enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes
      knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one
      interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up
      surveys and an exit interview elicited information about their opinions of the texting
      program. Additional goals included determining feasibility for future expansion as a trial.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm feasibility and pilot testing study of a curriculum
primary purpose: Other
masking: None (Open Label)
measure: Patient satisfaction and feedback
time frame: Up to 42 weeks
description: A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)
measure: Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
time frame: Up to 42 weeks
description: Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
measure: Barriers and facilitators of diabetes self-management
time frame: Study enrollment
description: Qualitative interview of patient experiences regarding having diabetes during pregnancy
measure: Study feasibility (as measured by number of participants retained in the study)
time frame: Up to 42 weeks
description: Ability to recruit and retain participants
measure: Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
time frame: Up to 42 weeks
description: Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
arm group label: Texting
arm group type: Other
description: Texting group
intervention type: Behavioral
intervention name: Texting group
description: Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.
arm group label: Texting
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melissa A Simon, MD, MPH
role: Principal Investigator
affiliation: Northwestern University
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Lynn M Yee
investigator title: Assistant Professor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: Undecided