xml: <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/NCT06022601</url>
    </required_header>
    <id_info>
      <org_study_id>292085</org_study_id>
      <nct_id>NCT06022601</nct_id>
    </id_info>
    <brief_title>Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia</brief_title>
    <acronym>Post-GDM-DNA</acronym>
    <official_title>Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College Healthcare NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College Healthcare NHS Trust</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>
        STUDY SUMMARY&#xD;
  &#xD;
        TITLE Post-delivery intervention in women with previous gestational diabetes mellitus for&#xD;
        weight loss, glycaemia and cardiovascular health DESIGN Feasibility study Allocation: RCT&#xD;
        AIMS To determine the feasibility of a post-delivery intervention to improve glycemia and&#xD;
        cardiovascular function and promote weight loss in women who have had gestational diabetes.&#xD;
  &#xD;
        OUTCOME MEASURES Primary outcome; Effect of intervention on HbA1c: difference in HbA1c&#xD;
        between intervention arm and control arm measured at 12 weeks.&#xD;
  &#xD;
        Secondary Outcomes;&#xD;
  &#xD;
          -  Adherence to intervention;&#xD;
  &#xD;
          -  Willingness to be randomised to post-delivery intervention;&#xD;
  &#xD;
          -  Process measures to evaluate patient experience of study and intervention;&#xD;
  &#xD;
          -  Participants' preferred time to commence the study, within the start date allowance of 6&#xD;
             weeks - 6 month post-delivery.&#xD;
  &#xD;
          -  Between-arm differences and within-arm differences to evaluate:&#xD;
  &#xD;
               -  Effect of intervention on HbA1c at 12 and 24 weeks&#xD;
  &#xD;
               -  Effect of intervention on weight and BMI at 12 and 24 weeks&#xD;
  &#xD;
               -  Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks&#xD;
  &#xD;
               -  Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24&#xD;
                  weeks&#xD;
  &#xD;
               -  Effect of intervention on physical activity at 12 and 24 weeks POPULATION We will&#xD;
                  recruit 50 women aged 18-45 with previous gestational diabetes and randomise them&#xD;
                  to 1 of 2 arms to commence study at 6 weeks - 6 months post-delivery. Women&#xD;
                  starting the study at 13 weeks post-delivery will have their routine post-delivery&#xD;
                  HbA1c act as baseline HBA1c.&#xD;
  &#xD;
        ELIGIBILITY Pregnant women with gestational diabetes (women will be given the option to start&#xD;
        the study between 6 weeks and 6 months post-delivery) or women who have given birth in the&#xD;
        last 12 months and had gestational diabetes during that pregnancy; aged 18-45; and access to&#xD;
        a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above.&#xD;
  &#xD;
        DURATION Study duration: 1/4/21-1/9/22. Participant duration: 24 weeks&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        STUDY OBJECTIVES Objectives&#xD;
  &#xD;
        To assess:&#xD;
  &#xD;
          1. Effect of intervention on HbA1c at 12 and 24 weeks&#xD;
  &#xD;
          2. Adherence to intervention&#xD;
  &#xD;
          3. Participants' preferred time to commence the study, within the start date allowance of 6&#xD;
             weeks - 6 month post-delivery.&#xD;
  &#xD;
          4. Qualitative data on how participants found post-delivery intervention&#xD;
  &#xD;
          5. Effect of intervention on weight at 12 and 24 weeks&#xD;
  &#xD;
          6. Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks&#xD;
  &#xD;
          7. Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks&#xD;
  &#xD;
          8. Effect of intervention on physical activity at 12 and 24 weeks&#xD;
  &#xD;
        3. STUDY DESIGN We will conduct a feasibility study for an open-label, randomised, controlled&#xD;
        trial of a personalised post-delivery intervention (DNA Nudge) to improve weight, glycaemia&#xD;
        and cardiovascular function in women with previous GDM.&#xD;
  &#xD;
        The study is designed to be remote, to enable the study to begin and continue in the pandemic&#xD;
        and minimise barriers to recruitment. Study participants will be provided with equipment and&#xD;
        instructions to collect samples and measurements at home. Contact with the research team will&#xD;
        be over telephone or Microsoft Teams video call.&#xD;
  &#xD;
        We will advertise in diabetes antenatal clinics using word-of-mouth, posters, social media&#xD;
        and on departmental emails at Imperial College Healthcare NHS Trust or Imperial College for&#xD;
        women with current/previous GDM aged 18-45. We will recruit via Twitter, email and in-person&#xD;
        encounters.&#xD;
  &#xD;
        We will randomise women to 1 of 2 arms:&#xD;
  &#xD;
        Arm 1: Standard dietary and physical activity advice as per NICE guidelines at week 1 (active&#xD;
        control arm; n = 25) Arm 2: DNA-based personalised dietary and physical advice delivered by&#xD;
        DNA Nudge dietician at week 1 and by DNA Nudge wearable and app for weeks 1-24 (intervention&#xD;
        arm; n = 25)&#xD;
  &#xD;
        Women not randomised to DNA Nudge will be provided with an activity app/wearable device&#xD;
        (Fitbit) to monitor daily step count. All women will be provided with a home BP monitor and&#xD;
        weighing scales.&#xD;
  &#xD;
        Week 1 Eligibility assessment, consent, randomisation, IPAQ questionnaire, baseline BP and&#xD;
        weight, blood sample collected for baseline lipid profile.&#xD;
  &#xD;
        Some women will begin the study at 13 weeks post-delivery and coincide with the routine&#xD;
        postnatal HbA1c for women with GDM. The routine post-delivery HbA1c will be baseline HbA1c&#xD;
        for this study. For women who commence the study outside the 13 weeks post-delivery window, a&#xD;
        finger prick blood sample will be used for a baseline HbA1c test.&#xD;
  &#xD;
        Women in the control arm will be given standard dietary and physical activity advice by the&#xD;
        research team, in line with NICE guidelines.&#xD;
  &#xD;
        Women in the DNA Nudge arm will provide a cheek swab for DNA analysis, carried out by DNA&#xD;
        Nudge. They will be given personalised dietary advice by a DNA Nudge dietician, and be&#xD;
        provided with DNA Nudge wearable, app and instructions.&#xD;
  &#xD;
        Week 6:&#xD;
  &#xD;
        Telephone/video-call follow-up to check ongoing willingness to participate and assess&#xD;
        adherence.&#xD;
  &#xD;
        Week 12:&#xD;
  &#xD;
        Collect weight and BP data from weeks 1-12, collect blood sample for HbA1c and lipid profile.&#xD;
        Check ongoing willingness to participate and assess adherence.&#xD;
  &#xD;
        Week 18:&#xD;
  &#xD;
        Telephone/video-call follow-up to check ongoing willingness to participate and assess&#xD;
        adherence.&#xD;
  &#xD;
        Week 24:&#xD;
  &#xD;
        Collect weight and BP data from weeks 12-24, follow-up IPAQ questionnaire, collect blood&#xD;
        sample for HbA1c and lipid profile, return devices and collect usage data from DNA Nudge.&#xD;
        Qualitative questionnaire to explore intervention experience.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c</measure>
      <time_frame>12 weeks</time_frame>
      <description>Glycaemia</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HbA1c</measure>
      <time_frame>24 weeks</time_frame>
      <description>Glycaemia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>12 weeks</time_frame>
      <description>kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>24 weeks</time_frame>
      <description>kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic and diastolic Blood pressure</measure>
      <time_frame>12 weeks</time_frame>
      <description>mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic and Diastolic Blood pressure</measure>
      <time_frame>24 weeks</time_frame>
      <description>mmHg</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Gestational Diabetes</condition>
    <arm_group>
      <arm_group_label>DNA Nudge</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DNA Nudge wearable and app, DNA-based dietary advice</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Fitbit, standard dietary advice</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DNA Nudge</intervention_name>
      <description>DNA Nudge wearable, DNA-based dietary advice</description>
      <arm_group_label>DNA Nudge</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with gestational diabetes (women will be given the option to start the&#xD;
               study between 6 weeks and 6 months post-delivery) or&#xD;
  &#xD;
            -  women who have given birth in the last 12 months and had gestational diabetes during&#xD;
               that pregnancy&#xD;
  &#xD;
            -  aged 18-45,&#xD;
  &#xD;
            -  access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or&#xD;
               above&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetes outside of pregnancy (diagnosis of type 1 or 2 diabetes; or HbA1c 48 mmol/mol&#xD;
               or above).&#xD;
  &#xD;
            -  Health contra-indications to moderate-vigorous exercise.&#xD;
  &#xD;
            -  Planning pregnancy during the study period or become pregnant during the study period.&#xD;
               -Cancer&#xD;
  &#xD;
            -  kidney disease&#xD;
  &#xD;
            -  liver disease&#xD;
  &#xD;
            -  pancreatitis.&#xD;
  &#xD;
            -  gastric bypass surgery or similar weight loss surgery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Edward Mullins</last_name>
      <phone>07881029947</phone>
      <email>edward.mullins@imperial.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Becky Ward</last_name>
      <phone>02075949459</phone>
      <email>becky.ward@imperial.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Imperial College Healthcare NHS Trust</name>
        <address>
          <city>London</city>
          <zip>W12 0HS</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Edward WS Mullins, PhD</last_name>
        <phone>07881029947</phone>
        <email>edward.mullins@imperial.ac.uk</email>
      </contact>
      <investigator>
        <last_name>Edward WS Mullins, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christoph C Lees, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes, Gestational</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be available on request from the PI</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </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>March 8, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT06022601/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022601
  org study id: 292085
  nct id: NCT06022601
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  STUDY SUMMARY
  
        TITLE Post-delivery intervention in women with previous gestational diabetes mellitus for
        weight loss, glycaemia and cardiovascular health DESIGN Feasibility study Allocation: RCT
        AIMS To determine the feasibility of a post-delivery intervention to improve glycemia and
        cardiovascular function and promote weight loss in women who have had gestational diabetes.
  
        OUTCOME MEASURES Primary outcome; Effect of intervention on HbA1c: difference in HbA1c
        between intervention arm and control arm measured at 12 weeks.
  
        Secondary Outcomes;
  
          -  Adherence to intervention;
  
          -  Willingness to be randomised to post-delivery intervention;
  
          -  Process measures to evaluate patient experience of study and intervention;
  
          -  Participants' preferred time to commence the study, within the start date allowance of 6
             weeks - 6 month post-delivery.
  
          -  Between-arm differences and within-arm differences to evaluate:
  
               -  Effect of intervention on HbA1c at 12 and 24 weeks
  
               -  Effect of intervention on weight and BMI at 12 and 24 weeks
  
               -  Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks
  
               -  Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24
                  weeks
  
               -  Effect of intervention on physical activity at 12 and 24 weeks POPULATION We will
                  recruit 50 women aged 18-45 with previous gestational diabetes and randomise them
                  to 1 of 2 arms to commence study at 6 weeks - 6 months post-delivery. Women
                  starting the study at 13 weeks post-delivery will have their routine post-delivery
                  HbA1c act as baseline HBA1c.
  
        ELIGIBILITY Pregnant women with gestational diabetes (women will be given the option to start
        the study between 6 weeks and 6 months post-delivery) or women who have given birth in the
        last 12 months and had gestational diabetes during that pregnancy; aged 18-45; and access to
        a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above.
  
        DURATION Study duration: 1/4/21-1/9/22. Participant duration: 24 weeks
  STUDY OBJECTIVES Objectives
  
        To assess:
  
          1. Effect of intervention on HbA1c at 12 and 24 weeks
  
          2. Adherence to intervention
  
          3. Participants' preferred time to commence the study, within the start date allowance of 6
             weeks - 6 month post-delivery.
  
          4. Qualitative data on how participants found post-delivery intervention
  
          5. Effect of intervention on weight at 12 and 24 weeks
  
          6. Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks
  
          7. Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks
  
          8. Effect of intervention on physical activity at 12 and 24 weeks
  
        3. STUDY DESIGN We will conduct a feasibility study for an open-label, randomised, controlled
        trial of a personalised post-delivery intervention (DNA Nudge) to improve weight, glycaemia
        and cardiovascular function in women with previous GDM.
  
        The study is designed to be remote, to enable the study to begin and continue in the pandemic
        and minimise barriers to recruitment. Study participants will be provided with equipment and
        instructions to collect samples and measurements at home. Contact with the research team will
        be over telephone or Microsoft Teams video call.
  
        We will advertise in diabetes antenatal clinics using word-of-mouth, posters, social media
        and on departmental emails at Imperial College Healthcare NHS Trust or Imperial College for
        women with current/previous GDM aged 18-45. We will recruit via Twitter, email and in-person
        encounters.
  
        We will randomise women to 1 of 2 arms:
  
        Arm 1: Standard dietary and physical activity advice as per NICE guidelines at week 1 (active
        control arm; n = 25) Arm 2: DNA-based personalised dietary and physical advice delivered by
        DNA Nudge dietician at week 1 and by DNA Nudge wearable and app for weeks 1-24 (intervention
        arm; n = 25)
  
        Women not randomised to DNA Nudge will be provided with an activity app/wearable device
        (Fitbit) to monitor daily step count. All women will be provided with a home BP monitor and
        weighing scales.
  
        Week 1 Eligibility assessment, consent, randomisation, IPAQ questionnaire, baseline BP and
        weight, blood sample collected for baseline lipid profile.
  
        Some women will begin the study at 13 weeks post-delivery and coincide with the routine
        postnatal HbA1c for women with GDM. The routine post-delivery HbA1c will be baseline HbA1c
        for this study. For women who commence the study outside the 13 weeks post-delivery window, a
        finger prick blood sample will be used for a baseline HbA1c test.
  
        Women in the control arm will be given standard dietary and physical activity advice by the
        research team, in line with NICE guidelines.
  
        Women in the DNA Nudge arm will provide a cheek swab for DNA analysis, carried out by DNA
        Nudge. They will be given personalised dietary advice by a DNA Nudge dietician, and be
        provided with DNA Nudge wearable, app and instructions.
  
        Week 6:
  
        Telephone/video-call follow-up to check ongoing willingness to participate and assess
        adherence.
  
        Week 12:
  
        Collect weight and BP data from weeks 1-12, collect blood sample for HbA1c and lipid profile.
        Check ongoing willingness to participate and assess adherence.
  
        Week 18:
  
        Telephone/video-call follow-up to check ongoing willingness to participate and assess
        adherence.
  
        Week 24:
  
        Collect weight and BP data from weeks 12-24, follow-up IPAQ questionnaire, collect blood
        sample for HbA1c and lipid profile, return devices and collect usage data from DNA Nudge.
        Qualitative questionnaire to explore intervention experience.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: HbA1c
  time frame: 12 weeks
  description: Glycaemia
  measure: HbA1c
  time frame: 24 weeks
  description: Glycaemia
  measure: Weight
  time frame: 12 weeks
  description: kg
  measure: Weight
  time frame: 24 weeks
  description: kg
  measure: Systolic and diastolic Blood pressure
  time frame: 12 weeks
  description: mmHg
  measure: Systolic and Diastolic Blood pressure
  time frame: 24 weeks
  description: mmHg
  arm group label: DNA Nudge
  arm group type: Experimental
  description: DNA Nudge wearable and app, DNA-based dietary advice
  arm group label: Control
  arm group type: No Intervention
  description: Fitbit, standard dietary advice
  intervention type: Device
  intervention name: DNA Nudge
  description: DNA Nudge wearable, DNA-based dietary advice
  arm group label: DNA Nudge
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Edward Mullins
  phone: 07881029947
  email: edward.mullins@imperial.ac.uk
  last name: Becky Ward
  phone: 02075949459
  email: becky.ward@imperial.ac.uk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Diabetes, Gestational
  mesh term: Diabetes Mellitus
  sharing ipd: Yes
  ipd description: Data will be available on request from the PI
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  provided document: 