<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/NCT03240874</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205409</org_study_id>
    <secondary_id>1R21HD094271-01</secondary_id>
    <secondary_id>5R21HD094271-02</secondary_id>
    <nct_id>NCT03240874</nct_id>
  </id_info>
  <brief_title>SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women</brief_title>
  <official_title>SweetMama Usability and Feasibility: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</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 is a challenging clinical situation requiring substantial patient&#xD;
      engagement. The investigators have developed a novel early-phase tool, called SweetMama, that&#xD;
      incorporates educational, motivational and supportive elements to positively impact maternal&#xD;
      health behaviors. This phase of work involves develop an optimized version of SweetMama via a&#xD;
      2-step sequential process of in-depth usability and feasibility testing. First the&#xD;
      investigators will conduct focus groups and individual usability testing followed by&#xD;
      refinement of SweetMama based on participant input. Next, the investigators will conduct&#xD;
      feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and&#xD;
      pilot procedures for a fully powered larger trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In prior work, the investigators created a text messaging curriculum that was well-received&#xD;
      by patients for diabetes-related education and support during pregnancy. The team has now&#xD;
      drawn upon these earlier phases to develop a mobile health behavior tool to educate and&#xD;
      support low-income, minority pregnant women with Gestational Diabetes Mellitus and Type 2&#xD;
      Diabetes Mellitus. This &quot;first-of-its-kind&quot; mHealth platform for pregnant women with GDM or&#xD;
      T2DM is called SweetMama. SweetMama is a theory-driven application that delivers an&#xD;
      interactive, goal-oriented educational and motivational diabetes-focused curriculum.&#xD;
      SweetMama currently functions as a user-friendly application in which participants are&#xD;
      delivered curriculum messages and have the opportunity to receive novel educational,&#xD;
      motivational, or supportive content when desired by patients; they additionally have the&#xD;
      opportunity to view library content and receive support with goal-setting.&#xD;
&#xD;
      To perform usability testing, the investigators will first conduct focus groups with 10-20&#xD;
      low-income pregnant women with diabetes to evaluate tool functionality, design, and&#xD;
      interpretability. The investigators will then conduct a phase of individual usability testing&#xD;
      with 20 women, who will use SweetMama for 2 weeks followed by qualitative (interviews) and&#xD;
      quantitative (questionnaires and user interaction data) assessments of tool satisfaction and&#xD;
      use.&#xD;
&#xD;
      Next, to perform feasibility testing, the investigators will recruit approximately 40&#xD;
      low-income pregnant women with diabetes to be randomized to either usual care or SweetMama&#xD;
      care, from the beginning of their enrollment at this clinical site for diabetes-specific&#xD;
      prenatal care through the first 8 weeks postpartum. Randomization will be unbalanced to favor&#xD;
      receipt of the intervention. Participants will undergo surveys and interviews at multiple&#xD;
      time points, and those who are randomized to experience SweetMama will undergo an exit&#xD;
      interview. Outcomes will include retention, treatment adherence, functionality of the tool,&#xD;
      and user interactivity with the tool. The expected outcome of the pilot RCT phase is a better&#xD;
      understanding of feasibility of a SweetMama trial via field testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">April 9, 2021</completion_date>
  <primary_completion_date type="Actual">April 9, 2021</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>
    <intervention_model_description>Two phases of study:&#xD;
Usability testing - focus groups followed by individual usability testing (single arm)&#xD;
Feasibility testing - pilot randomized controlled trial of SweetMama care versus usual care</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Identifying Themes on SweetMama Features</measure>
    <time_frame>60-90 minutes</time_frame>
    <description>Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Used the SweetMama Application</measure>
    <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
    <description>Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual User Feedback on SweetMama Features</measure>
    <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
    <description>For the usability phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field for after 2 weeks of enrollment. For the feasibility phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field after 8 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usage Time of SweetMama Application</measure>
    <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
    <description>User interaction with the SweetMama application for the total usage time of the application in minutes was assessed at two timepoints. In the individual usability phase, total usage time of the application was evaluated after 2 weeks of enrollment. In the feasibility phase, total usage time of the application was evaluated after 8 weeks postpartum. The reported number is minutes of use which is a total number of minutes of usage time after 2 weeks of enrollment and after 8 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability Testing of SweetMama Application With the System Usability Scale Survey</measure>
    <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
    <description>Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100&#xD;
1=Acceptable(&gt;70) 2=Marginal(50&lt;SUS&lt;=70) 3=Not Acceptable(&lt;=50) Usability testing of the SweetMama application with System Usability Scale was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire</measure>
    <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))</time_frame>
    <description>Usability of SweetMama will be assessed using the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire. The higher the participant scored means the participant did better.&#xD;
Usefulness: (sum(use_1 - use_8)/56)*100, range from 14.29 to 100 Satisfaction: (sum(use_24-use_30)/49)*100, range from 14.29 to 100 Ease of Use (USE): (sum(use_9-use_19)/77)*100, range from 14.29 to 100 Usability testing of the SweetMama application was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Self-efficacy</measure>
    <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
    <description>Diabetes self-efficacy measured via patient-reported outcomes (Diabetes Empowerment Scale), which is scored from 8 to 40 (sum of individual items), where higher total scores indicate higher self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation</measure>
    <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
    <description>Patient activation measured patient engagement in healthcare via patient-reported outcomes (Patient Activation Measure), which is scored from 0 to 100 (sum of all scores, scaled to a 0-100-point system), where higher scores indicate greater activation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Hemoglobin A1c From Enrollment to Delivery</measure>
    <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
    <description>Hemoglobin A1c will be assessed as a continuous measure reflecting the difference from enrollment to final. A1c before delivery, we controlled for A1c at enrollment and week difference</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy</measure>
    <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
    <description>In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Cesarean Deliveries</measure>
    <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
    <description>In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Outcomes of Pregnancy - Neonatal Birthweight</measure>
    <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
    <description>In feasibility testing participants, clinical outcomes include neonatal birthweight.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia</measure>
    <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
    <description>In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (&lt;40 mg/dL).</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission</measure>
    <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
    <description>In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Usability - Focus Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile Application Usability Testing: SweetMama Focus Groups&#xD;
Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usability - Individual Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feasibility - Pilot Randomized Trial, SweetMama arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feasibility - Pilot Randomized Trial, usual care arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SweetMama Focus Groups</intervention_name>
    <description>Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.</description>
    <arm_group_label>Usability - Focus Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SweetMama Individual Testing</intervention_name>
    <description>Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
    <arm_group_label>Usability - Individual Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SweetMama Feasibility Testing - Pilot Randomized Trial</intervention_name>
    <description>Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
    <arm_group_label>Feasibility - Pilot Randomized Trial, SweetMama arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Gestational diabetes mellitus or type 2 diabetes mellitus&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Gestational age&#xD;
&#xD;
          -  Focus groups: Confirmed intrauterine pregnancy at least 8 weeks' gestational age or&#xD;
             postpartum until 12 weeks after delivery&#xD;
&#xD;
          -  Individual testing: Confirmed intrauterine pregnancy prior to 30 weeks' gestational&#xD;
             age&#xD;
&#xD;
          -  Pilot trial: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age&#xD;
&#xD;
          -  Low income, defined as use of publicly-supported insurance for prenatal care or&#xD;
             household income &lt;200% of poverty line for family size&#xD;
&#xD;
          -  Access to a mobile smartphone ( for longitudinal testing phase)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet the inclusion criteria above&#xD;
&#xD;
          -  Non-viable pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn M Yee, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor, Maternal and Fetal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</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>
  <reference>
    <citation>Gomez H, DiTosto JD, Niznik CM, Yee LM. Understanding Food Security as a Social Determinant of Diabetes-Related Health during Pregnancy. Am J Perinatol. 2023 Jun;40(8):825-832. doi: 10.1055/s-0041-1740194. Epub 2021 Nov 28.</citation>
    <PMID>34839467</PMID>
  </reference>
  <results_reference>
    <citation>Leziak K, Birch E, Jackson J, Strohbach A, Niznik C, Yee LM. Identifying Mobile Health Technology Experiences and Preferences of Low-Income Pregnant Women with Diabetes. J Diabetes Sci Technol. 2021 Sep;15(5):1018-1026. doi: 10.1177/1932296821993175. Epub 2021 Feb 19.</citation>
    <PMID>33605158</PMID>
  </results_reference>
  <results_reference>
    <citation>Jackson J, Leziak K, Niznik CM, Yee LM. Health Care Providers' Utilization of and Perspectives on Mobile Health Technology for Diabetes and Pregnancy Support. Diabetes Spectr. 2021 Aug;34(3):257-267. doi: 10.2337/ds20-0040. Epub 2021 Mar 9.</citation>
    <PMID>34511852</PMID>
  </results_reference>
  <results_reference>
    <citation>Yee LM, Leziak K, Jackson J, Strohbach A, Saber R, Niznik CM, Simon MA. Patient and Provider Perspectives on a Novel Mobile Health Intervention for Low-Income Pregnant Women With Gestational or Type 2 Diabetes Mellitus. J Diabetes Sci Technol. 2021 Sep;15(5):1121-1133. doi: 10.1177/1932296820937347. Epub 2020 Jul 5.</citation>
    <PMID>32627582</PMID>
  </results_reference>
  <results_reference>
    <citation>Steinberg JR, Yeh C, Jackson J, Saber R, Niznik CM, Leziak K, Yee LM. Optimizing Engagement in an mHealth Intervention for Diabetes Support During Pregnancy: the Role of Baseline Patient Health and Behavioral Characteristics. J Diabetes Sci Technol. 2022 Nov;16(6):1466-1472. doi: 10.1177/19322968211035441. Epub 2021 Aug 22.</citation>
    <PMID>34423677</PMID>
  </results_reference>
  <results_reference>
    <citation>Yee LM, Leziak K, Jackson J, Niznik CM, Simon MA. Health Care Providers' Perspectives on Barriers and Facilitators to Care for Low-Income Pregnant Women With Diabetes. Diabetes Spectr. 2020 May;33(2):190-200. doi: 10.2337/ds19-0044.</citation>
    <PMID>32425457</PMID>
  </results_reference>
  <results_reference>
    <citation>Birch EM, Leziak K, Jackson J, Dahl E, Niznik CM, Yee LM. Content Quality of YouTube Videos About Gestational Diabetes: Systematic Evaluation. JMIR Diabetes. 2022 Apr 7;7(2):e30156. doi: 10.2196/30156.</citation>
    <PMID>35389355</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>August 14, 2022</results_first_submitted>
  <results_first_submitted_qc>February 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2023</results_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</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, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Gestational Diabetes</keyword>
  <keyword>Diabetes Type 2 in Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03240874/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Focus Group Usability Testing</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03240874/ICF_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Individual Usability Testing</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03240874/ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usability - Focus Group</title>
          <description>Mobile Application Usability Testing: SweetMama Focus Groups&#xD;
Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.&#xD;
SweetMama Focus Groups: Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.</description>
        </group>
        <group group_id="P2">
          <title>Usability - Individual Testing</title>
          <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
        </group>
        <group group_id="P3">
          <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
        </group>
        <group group_id="P4">
          <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usability - Focus Group</title>
          <description>Mobile Application Usability Testing: SweetMama Focus Groups&#xD;
Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.&#xD;
SweetMama Focus Groups: Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.</description>
        </group>
        <group group_id="B2">
          <title>Usability - Individual Testing</title>
          <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
        </group>
        <group group_id="B3">
          <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
        </group>
        <group group_id="B4">
          <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
        </group>
        <group group_id="B5">
          <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="16"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>The usability and feasibility phases did not occur at the same time so age was not analyzed together.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="6"/>
                    <measurement group_id="B2" value="32.07" spread="5.32"/>
                    <measurement group_id="B3" value="31.35" spread="4.73"/>
                    <measurement group_id="B4" value="31.30" spread="6.91"/>
                    <measurement group_id="B5" value="31.89" spread="5.52"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="20"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Gestational diabetes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type 2 diabetes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Publicly funded insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>For the usability phase qualitative (interviews) and quantitative (questionnaires and user interaction data) were collected. The focus group, individual usability testing, and feasibility pilot phase were analyzed separately. BMI was collected for the individual usability phase and the feasibility phase. BMI was not collected for the usability focus group. No demographics were collected to determine BMI.</description>
          <population>BMI was collected for the individual usability phase and the feasibility phase. For the usability focus group, no participants were analyzed for BMI and no data was collected.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="37.20" spread="8.08"/>
                    <measurement group_id="B3" value="42.94" spread="12.40"/>
                    <measurement group_id="B4" value="36.67" spread="9.03"/>
                    <measurement group_id="B5" value="39.81" spread="10.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Identifying Themes on SweetMama Features</title>
        <description>Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.</description>
        <time_frame>60-90 minutes</time_frame>
        <population>Focus group participants with confirmed diagnosis of Gestational Diabetes or Type 2 Diabetes. We recorded the identified themes and the number of participants who expressed each theme.</population>
        <group_list>
          <group group_id="O1">
            <title>Usability - Individual Testing</title>
            <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Identifying Themes on SweetMama Features</title>
          <description>Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.</description>
          <population>Focus group participants with confirmed diagnosis of Gestational Diabetes or Type 2 Diabetes. We recorded the identified themes and the number of participants who expressed each theme.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visual features personalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aesthetic appeal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Content organization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Content is practical and helpful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Goal-setting activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Option to &quot;favorite&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interactivity of messages</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Used the SweetMama Application</title>
        <description>Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).</description>
        <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
        <population>Participants assigned to use the SweetMama application or usual care.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Used the SweetMama Application</title>
          <description>Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).</description>
          <population>Participants assigned to use the SweetMama application or usual care.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ever used application</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used application at least once/week during pregnancy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Used application at least once/week during postpartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Individual User Feedback on SweetMama Features</title>
        <description>For the usability phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field for after 2 weeks of enrollment. For the feasibility phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field after 8 weeks postpartum.</description>
        <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
        <posting_date>07/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usage Time of SweetMama Application</title>
        <description>User interaction with the SweetMama application for the total usage time of the application in minutes was assessed at two timepoints. In the individual usability phase, total usage time of the application was evaluated after 2 weeks of enrollment. In the feasibility phase, total usage time of the application was evaluated after 8 weeks postpartum. The reported number is minutes of use which is a total number of minutes of usage time after 2 weeks of enrollment and after 8 weeks postpartum.</description>
        <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
        <population>Participants enrolled to engage with the SweetMama application in both Aim 1 and Aim 2. For usability testing, N= 23 because one participant never opened the application which removes the participant from the analysis population of this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Usability - Individual Testing</title>
            <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage Time of SweetMama Application</title>
          <description>User interaction with the SweetMama application for the total usage time of the application in minutes was assessed at two timepoints. In the individual usability phase, total usage time of the application was evaluated after 2 weeks of enrollment. In the feasibility phase, total usage time of the application was evaluated after 8 weeks postpartum. The reported number is minutes of use which is a total number of minutes of usage time after 2 weeks of enrollment and after 8 weeks postpartum.</description>
          <population>Participants enrolled to engage with the SweetMama application in both Aim 1 and Aim 2. For usability testing, N= 23 because one participant never opened the application which removes the participant from the analysis population of this outcome.</population>
          <units>minutes of SweetMama use</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" lower_limit="11.53" upper_limit="27.93"/>
                    <measurement group_id="O2" value="48.53" lower_limit="23.53" upper_limit="69.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability Testing of SweetMama Application With the System Usability Scale Survey</title>
        <description>Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100&#xD;
1=Acceptable(&gt;70) 2=Marginal(50&lt;SUS&lt;=70) 3=Not Acceptable(&lt;=50) Usability testing of the SweetMama application with System Usability Scale was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
        <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)</time_frame>
        <population>In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up.&#xD;
In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Usability - Individual Testing</title>
            <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability Testing of SweetMama Application With the System Usability Scale Survey</title>
          <description>Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100&#xD;
1=Acceptable(&gt;70) 2=Marginal(50&lt;SUS&lt;=70) 3=Not Acceptable(&lt;=50) Usability testing of the SweetMama application with System Usability Scale was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
          <population>In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up.&#xD;
In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.00" lower_limit="60.00" upper_limit="87.50"/>
                    <measurement group_id="O2" value="85.00" lower_limit="70.00" upper_limit="88.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire</title>
        <description>Usability of SweetMama will be assessed using the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire. The higher the participant scored means the participant did better.&#xD;
Usefulness: (sum(use_1 - use_8)/56)*100, range from 14.29 to 100 Satisfaction: (sum(use_24-use_30)/49)*100, range from 14.29 to 100 Ease of Use (USE): (sum(use_9-use_19)/77)*100, range from 14.29 to 100 Usability testing of the SweetMama application was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
        <time_frame>After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))</time_frame>
        <population>In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up.&#xD;
In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Usability - Individual Testing</title>
            <description>Mobile Application Usability Testing: SweetMama Individual Testing&#xD;
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.&#xD;
SweetMama Individual Testing: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire</title>
          <description>Usability of SweetMama will be assessed using the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire. The higher the participant scored means the participant did better.&#xD;
Usefulness: (sum(use_1 - use_8)/56)*100, range from 14.29 to 100 Satisfaction: (sum(use_24-use_30)/49)*100, range from 14.29 to 100 Ease of Use (USE): (sum(use_9-use_19)/77)*100, range from 14.29 to 100 Usability testing of the SweetMama application was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.</description>
          <population>In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up.&#xD;
In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Usefulness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.93" lower_limit="64.29" upper_limit="94.64"/>
                    <measurement group_id="O2" value="82.14" lower_limit="71.43" upper_limit="85.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.71" lower_limit="83.12" upper_limit="97.40"/>
                    <measurement group_id="O2" value="88.31" lower_limit="84.42" upper_limit="94.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of Learning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.50" lower_limit="85.71" upper_limit="100.00"/>
                    <measurement group_id="O2" value="91.07" lower_limit="85.71" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.71" lower_limit="69.39" upper_limit="100.00"/>
                    <measurement group_id="O2" value="82.65" lower_limit="73.47" upper_limit="93.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Self-efficacy</title>
        <description>Diabetes self-efficacy measured via patient-reported outcomes (Diabetes Empowerment Scale), which is scored from 8 to 40 (sum of individual items), where higher total scores indicate higher self-efficacy</description>
        <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
        <population>In SweetMama arm, 28 completed the Diabetes self-efficacy measure at delivery; 2 missing for loss to follow-up and not delivered at site hospital.&#xD;
In the SweetMama arm, 27 completed Diabetes self-efficacy measure postpartum; 3 missing for not delivered at site hospital and 2 lost to follow-up.&#xD;
In the usual care arm, 9 completed Diabetes self-efficacy measure postpartum; 1 missing for pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Self-efficacy</title>
          <description>Diabetes self-efficacy measured via patient-reported outcomes (Diabetes Empowerment Scale), which is scored from 8 to 40 (sum of individual items), where higher total scores indicate higher self-efficacy</description>
          <population>In SweetMama arm, 28 completed the Diabetes self-efficacy measure at delivery; 2 missing for loss to follow-up and not delivered at site hospital.&#xD;
In the SweetMama arm, 27 completed Diabetes self-efficacy measure postpartum; 3 missing for not delivered at site hospital and 2 lost to follow-up.&#xD;
In the usual care arm, 9 completed Diabetes self-efficacy measure postpartum; 1 missing for pregnancy termination.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diabetes self-efficacy Delivery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.44" lower_limit="4.13" upper_limit="4.88"/>
                    <measurement group_id="O2" value="3.88" lower_limit="3.75" upper_limit="4.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes self-efficacy Postpartum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="4.13" upper_limit="4.88"/>
                    <measurement group_id="O2" value="4.50" lower_limit="4.13" upper_limit="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Activation</title>
        <description>Patient activation measured patient engagement in healthcare via patient-reported outcomes (Patient Activation Measure), which is scored from 0 to 100 (sum of all scores, scaled to a 0-100-point system), where higher scores indicate greater activation.</description>
        <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
        <population>In SweetMama arm, 28 completed Patient Activation Measure at delivery; 2 missing for 1 lost to follow-up and 1 participant not delivered at site hospital.&#xD;
In the SweetMama arm, 27 completed Patient Activation Measure postpartum; 3 missing for 1 participant not delivered at site hospital and 2 lost to follow-up.&#xD;
In the usual care arm, 9 complete Patient Activation Measure postpartum; 1 missing for pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation</title>
          <description>Patient activation measured patient engagement in healthcare via patient-reported outcomes (Patient Activation Measure), which is scored from 0 to 100 (sum of all scores, scaled to a 0-100-point system), where higher scores indicate greater activation.</description>
          <population>In SweetMama arm, 28 completed Patient Activation Measure at delivery; 2 missing for 1 lost to follow-up and 1 participant not delivered at site hospital.&#xD;
In the SweetMama arm, 27 completed Patient Activation Measure postpartum; 3 missing for 1 participant not delivered at site hospital and 2 lost to follow-up.&#xD;
In the usual care arm, 9 complete Patient Activation Measure postpartum; 1 missing for pregnancy termination.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient activation Delivery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.95" spread="11.44"/>
                    <measurement group_id="O2" value="88.31" spread="8.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient activation Postpartum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.55" spread="8.76"/>
                    <measurement group_id="O2" value="93.85" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Hemoglobin A1c From Enrollment to Delivery</title>
        <description>Hemoglobin A1c will be assessed as a continuous measure reflecting the difference from enrollment to final. A1c before delivery, we controlled for A1c at enrollment and week difference</description>
        <time_frame>After 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
        <population>For feasibility testing, N value differs because 1 participant was lost to follow-up in each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Hemoglobin A1c From Enrollment to Delivery</title>
          <description>Hemoglobin A1c will be assessed as a continuous measure reflecting the difference from enrollment to final. A1c before delivery, we controlled for A1c at enrollment and week difference</description>
          <population>For feasibility testing, N value differs because 1 participant was lost to follow-up in each arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin A1c - No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1c - Worsened by &gt;1% (got higher)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1c - Improved by &gt;1% (lower)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy</title>
        <description>In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.</description>
        <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
        <population>Participants in the feasibility testing- SweetMama application users and usual care participants</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy</title>
          <description>In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.</description>
          <population>Participants in the feasibility testing- SweetMama application users and usual care participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Cesarean Deliveries</title>
        <description>In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.</description>
        <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
        <population>In the usual care arm, 1 missing for pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cesarean Deliveries</title>
          <description>In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.</description>
          <population>In the usual care arm, 1 missing for pregnancy termination.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Outcomes of Pregnancy - Neonatal Birthweight</title>
        <description>In feasibility testing participants, clinical outcomes include neonatal birthweight.</description>
        <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
        <population>SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcomes of Pregnancy - Neonatal Birthweight</title>
          <description>In feasibility testing participants, clinical outcomes include neonatal birthweight.</description>
          <population>SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination.</population>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3089.13" spread="621.45"/>
                    <measurement group_id="O2" value="3042.33" spread="656.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia</title>
        <description>In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (&lt;40 mg/dL).</description>
        <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
        <population>N=9 in the usual care arm due to pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia</title>
          <description>In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (&lt;40 mg/dL).</description>
          <population>N=9 in the usual care arm due to pregnancy termination.</population>
          <units>number of babies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission</title>
        <description>In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.</description>
        <time_frame>After delivery (approximately 10-30 weeks of enrollment)</time_frame>
        <population>SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
          </group>
          <group group_id="O2">
            <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
            <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission</title>
          <description>In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.</description>
          <population>SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination.</population>
          <units>number of babies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from participant enrollment to after 8 weeks postpartum (approximately 18-38 weeks of enrollment)</time_frame>
      <desc>Study specific adverse events definitions were created based on FDA criteria. All events were unrelated to the study. The usability phase and feasibility phases were conducted separately and adverse events were not monitored at all for the usability phase and not included in this section. Adverse events were assessed for only participants related to the prenatal and postpartum periods which include events related to the labor and delivery or the immediate postpartum hospitalization.</desc>
      <group_list>
        <group group_id="E1">
          <title>Feasibility - Pilot Randomized Trial, SweetMama Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.&#xD;
SweetMama Feasibility Testing - Pilot Randomized Trial: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic &quot;check-ins&quot; with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.</description>
        </group>
        <group group_id="E2">
          <title>Feasibility - Pilot Randomized Trial, Usual Care Arm</title>
          <description>Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm&#xD;
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Preterm birth &lt;34 weeks of gestation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neonatal intensive care unit admission for pressor support, ventilator support, or anti-seizure medi</sub_title>
                <description>Only participants of infants with neonatal intensive care unit admission for pressor support, ventilator support, or anti-seizure medicine are considered as having adverse events. NICU admissions for other reasons were not considered in this section</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Maternal intensive care unit admission</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital admission requiring medical intervention or observation for a diabetes-related indication</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Preterm birth ≥34 weeks of gestation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Lynn Yee, MD, MPH</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-472-4685</phone>
      <email>lynn.yee@northwestern.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/NCT03240874
org study id: STU00205409
secondary id: 1R21HD094271-01
secondary id: 5R21HD094271-02
nct id: NCT03240874
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes during pregnancy is a challenging clinical situation requiring substantial patient
      engagement. The investigators have developed a novel early-phase tool, called SweetMama, that
      incorporates educational, motivational and supportive elements to positively impact maternal
      health behaviors. This phase of work involves develop an optimized version of SweetMama via a
      2-step sequential process of in-depth usability and feasibility testing. First the
      investigators will conduct focus groups and individual usability testing followed by
      refinement of SweetMama based on participant input. Next, the investigators will conduct
      feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and
      pilot procedures for a fully powered larger trial.
In prior work, the investigators created a text messaging curriculum that was well-received
      by patients for diabetes-related education and support during pregnancy. The team has now
      drawn upon these earlier phases to develop a mobile health behavior tool to educate and
      support low-income, minority pregnant women with Gestational Diabetes Mellitus and Type 2
      Diabetes Mellitus. This "first-of-its-kind" mHealth platform for pregnant women with GDM or
      T2DM is called SweetMama. SweetMama is a theory-driven application that delivers an
      interactive, goal-oriented educational and motivational diabetes-focused curriculum.
      SweetMama currently functions as a user-friendly application in which participants are
      delivered curriculum messages and have the opportunity to receive novel educational,
      motivational, or supportive content when desired by patients; they additionally have the
      opportunity to view library content and receive support with goal-setting.

      To perform usability testing, the investigators will first conduct focus groups with 10-20
      low-income pregnant women with diabetes to evaluate tool functionality, design, and
      interpretability. The investigators will then conduct a phase of individual usability testing
      with 20 women, who will use SweetMama for 2 weeks followed by qualitative (interviews) and
      quantitative (questionnaires and user interaction data) assessments of tool satisfaction and
      use.

      Next, to perform feasibility testing, the investigators will recruit approximately 40
      low-income pregnant women with diabetes to be randomized to either usual care or SweetMama
      care, from the beginning of their enrollment at this clinical site for diabetes-specific
      prenatal care through the first 8 weeks postpartum. Randomization will be unbalanced to favor
      receipt of the intervention. Participants will undergo surveys and interviews at multiple
      time points, and those who are randomized to experience SweetMama will undergo an exit
      interview. Outcomes will include retention, treatment adherence, functionality of the tool,
      and user interactivity with the tool. The expected outcome of the pilot RCT phase is a better
      understanding of feasibility of a SweetMama trial via field testing.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two phases of study:
Usability testing - focus groups followed by individual usability testing (single arm)
Feasibility testing - pilot randomized controlled trial of SweetMama care versus usual care
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Identifying Themes on SweetMama Features
time frame: 60-90 minutes
description: Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.
measure: Number of Participants Who Used the SweetMama Application
time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
description: Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).
measure: Individual User Feedback on SweetMama Features
time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
description: For the usability phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field for after 2 weeks of enrollment. For the feasibility phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field after 8 weeks postpartum.
measure: Usage Time of SweetMama Application
time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
description: User interaction with the SweetMama application for the total usage time of the application in minutes was assessed at two timepoints. In the individual usability phase, total usage time of the application was evaluated after 2 weeks of enrollment. In the feasibility phase, total usage time of the application was evaluated after 8 weeks postpartum. The reported number is minutes of use which is a total number of minutes of usage time after 2 weeks of enrollment and after 8 weeks postpartum.
measure: Usability Testing of SweetMama Application With the System Usability Scale Survey
time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
description: Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100
1=Acceptable(>70) 2=Marginal(50<SUS<=70) 3=Not Acceptable(<=50) Usability testing of the SweetMama application with System Usability Scale was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.
measure: Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
description: Usability of SweetMama will be assessed using the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire. The higher the participant scored means the participant did better.
Usefulness: (sum(use_1 - use_8)/56)*100, range from 14.29 to 100 Satisfaction: (sum(use_24-use_30)/49)*100, range from 14.29 to 100 Ease of Use (USE): (sum(use_9-use_19)/77)*100, range from 14.29 to 100 Usability testing of the SweetMama application was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.
measure: Diabetes Self-efficacy
time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
description: Diabetes self-efficacy measured via patient-reported outcomes (Diabetes Empowerment Scale), which is scored from 8 to 40 (sum of individual items), where higher total scores indicate higher self-efficacy
measure: Patient Activation
time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
description: Patient activation measured patient engagement in healthcare via patient-reported outcomes (Patient Activation Measure), which is scored from 0 to 100 (sum of all scores, scaled to a 0-100-point system), where higher scores indicate greater activation.
measure: Difference in Hemoglobin A1c From Enrollment to Delivery
time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
description: Hemoglobin A1c will be assessed as a continuous measure reflecting the difference from enrollment to final. A1c before delivery, we controlled for A1c at enrollment and week difference
measure: Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy
time frame: After delivery (approximately 10-30 weeks of enrollment)
description: In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.
measure: Number of Cesarean Deliveries
time frame: After delivery (approximately 10-30 weeks of enrollment)
description: In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.
measure: Clinical Outcomes of Pregnancy - Neonatal Birthweight
time frame: After delivery (approximately 10-30 weeks of enrollment)
description: In feasibility testing participants, clinical outcomes include neonatal birthweight.
measure: Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia
time frame: After delivery (approximately 10-30 weeks of enrollment)
description: In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (<40 mg/dL).
measure: Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission
time frame: After delivery (approximately 10-30 weeks of enrollment)
description: In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.
arm group label: Usability - Focus Group
arm group type: Experimental
description: Mobile Application Usability Testing: SweetMama Focus Groups
Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.
arm group label: Usability - Individual Testing
arm group type: Experimental
description: Mobile Application Usability Testing: SweetMama Individual Testing
Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.
arm group label: Feasibility - Pilot Randomized Trial, SweetMama arm
arm group type: Experimental
description: Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.
arm group label: Feasibility - Pilot Randomized Trial, usual care arm
arm group type: No Intervention
description: Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm
Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.
intervention type: Behavioral
intervention name: SweetMama Focus Groups
description: Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.
arm group label: Usability - Focus Group
intervention type: Behavioral
intervention name: SweetMama Individual Testing
description: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic "check-ins" with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.
arm group label: Usability - Individual Testing
intervention type: Behavioral
intervention name: SweetMama Feasibility Testing - Pilot Randomized Trial
description: Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic "check-ins" with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.
arm group label: Feasibility - Pilot Randomized Trial, SweetMama arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynn M Yee, MD, MPH
role: Principal Investigator
affiliation: Assistant Professor, Maternal and Fetal Medicine
facility: 
country: United States
citation: Gomez H, DiTosto JD, Niznik CM, Yee LM. Understanding Food Security as a Social Determinant of Diabetes-Related Health during Pregnancy. Am J Perinatol. 2023 Jun;40(8):825-832. doi: 10.1055/s-0041-1740194. Epub 2021 Nov 28.
PMID: 34839467
citation: Leziak K, Birch E, Jackson J, Strohbach A, Niznik C, Yee LM. Identifying Mobile Health Technology Experiences and Preferences of Low-Income Pregnant Women with Diabetes. J Diabetes Sci Technol. 2021 Sep;15(5):1018-1026. doi: 10.1177/1932296821993175. Epub 2021 Feb 19.
PMID: 33605158
citation: Jackson J, Leziak K, Niznik CM, Yee LM. Health Care Providers' Utilization of and Perspectives on Mobile Health Technology for Diabetes and Pregnancy Support. Diabetes Spectr. 2021 Aug;34(3):257-267. doi: 10.2337/ds20-0040. Epub 2021 Mar 9.
PMID: 34511852
citation: Yee LM, Leziak K, Jackson J, Strohbach A, Saber R, Niznik CM, Simon MA. Patient and Provider Perspectives on a Novel Mobile Health Intervention for Low-Income Pregnant Women With Gestational or Type 2 Diabetes Mellitus. J Diabetes Sci Technol. 2021 Sep;15(5):1121-1133. doi: 10.1177/1932296820937347. Epub 2020 Jul 5.
PMID: 32627582
citation: Steinberg JR, Yeh C, Jackson J, Saber R, Niznik CM, Leziak K, Yee LM. Optimizing Engagement in an mHealth Intervention for Diabetes Support During Pregnancy: the Role of Baseline Patient Health and Behavioral Characteristics. J Diabetes Sci Technol. 2022 Nov;16(6):1466-1472. doi: 10.1177/19322968211035441. Epub 2021 Aug 22.
PMID: 34423677
citation: Yee LM, Leziak K, Jackson J, Niznik CM, Simon MA. Health Care Providers' Perspectives on Barriers and Facilitators to Care for Low-Income Pregnant Women With Diabetes. Diabetes Spectr. 2020 May;33(2):190-200. doi: 10.2337/ds19-0044.
PMID: 32425457
citation: Birch EM, Leziak K, Jackson J, Dahl E, Niznik CM, Yee LM. Content Quality of YouTube Videos About Gestational Diabetes: Systematic Evaluation. JMIR Diabetes. 2022 Apr 7;7(2):e30156. doi: 10.2196/30156.
PMID: 35389355
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Lynn M Yee
investigator title: Assistant Professor, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 