<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/NCT03802877</url>
  </required_header>
  <id_info>
    <org_study_id>GRT 2017-16</org_study_id>
    <nct_id>NCT03802877</nct_id>
  </id_info>
  <brief_title>Active Patient GDM</brief_title>
  <official_title>ACTIVating and Engaging PAtients Through Clinical Interaction Redesign and Electronically- Integrated Novel Technologies Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Lawson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</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>
      Among women with GDM, the investigators will determine if a strategy of (1) a website-based&#xD;
      information and motivational resource bank; (2) biosensor/ePlatform-based physical activity&#xD;
      and GWG tracking; and/or (3) a health coach will lead to more favourably outcomes; namely,&#xD;
      GWG closer to target, higher physical activity levels, better glycemic and blood pressure&#xD;
      control, and lower incidence of LGA in offspring.&#xD;
&#xD;
      The current project is designed to assess feasibility and usability to inform the development&#xD;
      of a large randomized controlled trial. The investigators will monitor the implementation&#xD;
      process and examine patient-oriented outcomes, including perceptions of utility, challenges,&#xD;
      and burden. These will be assessed through telephone-based in-depth interview.&#xD;
&#xD;
      Methodology / Study design This is a feasibility randomized controlled trial with a factorial&#xD;
      design. The investigators will recruit women with a diagnosis of GDM between 24 and 28 weeks'&#xD;
      pregnancy. All will receive access to a website resource bank with tips and resources to&#xD;
      optimize physical activity and dietary intake a quality during pregnancy. In addition, they&#xD;
      will be randomized to one of the four following groups: (1) No additional intervention; (2)&#xD;
      ePlatform-based automated support combined with pedometer-based physical activity monitoring&#xD;
      and digital scale-based weight monitoring; (3) weekly telephone calls with a health coach to&#xD;
      discuss physical activity, eating, gestational weight gain; (4) combination of ePlatform and&#xD;
      telephone calls from a health coach.&#xD;
&#xD;
      The investigators will evaluate recruitment rates, drop-out rates, women's perceptions of the&#xD;
      strengths and limitations of the strategy, and ease and feasibility of outcome assessment.&#xD;
      Assessments will be through in-clinic assessments, on-line questionnaires, clinic-based&#xD;
      measures, mailed-in pedometers, and telephone-based interviews. Assessments will be at study&#xD;
      entry and two to three weeks before the expected date of delivery or date of scheduled&#xD;
      C-section. There will be a telephone-based interview at 12 weeks postpartum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our overarching aim is to determine, among women with gestational diabetes (GDM), if a&#xD;
      strategy of (1) a website-based information and motivational resource bank; (2)&#xD;
      biosensor/ePlatform-based physical activity and gestational weight gain (GWG) tracking;&#xD;
      and/or (3) a health coach will lead to more favourable outcomes; namely, GWG closer to&#xD;
      target, higher physical activity levels, better glycemic and blood pressure control, and&#xD;
      lower incidence of large for gestational age (LGA) in offspring.&#xD;
&#xD;
      The current project is designed to assess feasibility and usability to inform the development&#xD;
      of a large randomized controlled trial. The specific aims of this feasibility study are:&#xD;
&#xD;
        1. To determine the proportion of candidates with GDM who accept to participate in the&#xD;
           study at each site (recruitment rates); a minimum overall average recruitment rate of&#xD;
           25/month would favour proceeding to a larger trial.&#xD;
&#xD;
        2. To evaluate participant use (log ins) and perceived utility (interviews) of the website&#xD;
           resource that the investigators are developing; a minimum average of 5 log-ins overall&#xD;
           would favour proceeding to a larger trial&#xD;
&#xD;
        3. To determine use (number of planned weekly conversations completed) and perceived&#xD;
           utility (interviews) of the health coaching intervention; a minimum completion of 50% of&#xD;
           the planned weekly conversations would favour retaining this treatment arm in a larger&#xD;
           trial&#xD;
&#xD;
        4. To determine use (data upload of step counts and weight data onto ePlatform) and&#xD;
           perceived utility (interviews) of the ePlatform intervention ; a minimal upload of 30%&#xD;
           of days overall of data would favour retaining this treatment arm in a larger trial&#xD;
&#xD;
        5. To assess the proportion of participants in each intervention arm who complete final&#xD;
           evaluation procedures (loss to follow-up rates); a minimum retention of 75% of&#xD;
           participants enrolled would favour execution of a larger clinical trial&#xD;
&#xD;
      DESIGN Lawson ACTIVE PATIENT has a 2X2 factorial design. All participants will have access to&#xD;
      the information and motivational resource bank, housed on a dedicated study website. Each&#xD;
      participant will be randomized (1) to an ePlatform yes/no strategy and (2) to a health coach&#xD;
      yes/no strategy. Therefore, some participants will have access to the website only, others to&#xD;
      the website &amp; ePlatform, others to the website &amp; coach, and some to the website, ePlatform &amp;&#xD;
      coach. By interviewing and surveying participants in each of these groups, the investigators&#xD;
      will be able to ascertain if there are components that are redundant or synergistic.&#xD;
&#xD;
      RESOURCE BANK The website sections include (1) 'About' with an overview about GDM, its&#xD;
      management, and its complications; (2) 'Perspectives' with video and audio clips and&#xD;
      interviews with mothers with a GDM history, physicians, dietitians, and kinesiologists, all&#xD;
      describing their experiences living with or managing GDM and highlighting the importance of&#xD;
      attending to this condition both during pregnancy and thereafter; (3) 'Nutrition' with&#xD;
      descriptions and discussion of impact of eating on glucose control, illustration of the&#xD;
      'healthy plate' concepts, grocery shopping tips, links to healthy recipe banks, a&#xD;
      photographic repository of health snack ideas, healthy lunches, and healthy breakfasts; (4)&#xD;
      'Activity' with explanations for pedometer use, step count targets, physical activity&#xD;
      targets, step and physical activity monitoring, links to exercise video clips, precautions&#xD;
      during pregnancy; and (5) 'Postpartum' which will include future diabetes risk facts relevant&#xD;
      to mothers, fathers, and children; diabetes prevention approaches; and planning for future&#xD;
      pregnancies.&#xD;
&#xD;
      ePLATFORM WITH SENSORS Participants randomized to the ePlatform strategy (i.e., 50% of&#xD;
      participants) will receive a digital scale, physical activity monitor (pedometer), and&#xD;
      ePlatform log-in information. They will track daily weights and step counts. They will&#xD;
      receive prompts to access educational and motivational tools based on the data that they&#xD;
      enter and whether or not they enter data. The investigators will use the ePlatform developed&#xD;
      by StepsCount, a Canadian pedometer company with a well-developed ePlatform for pedometer&#xD;
      data upload, tracking, and automated messaging. The company is permitting us further&#xD;
      customization for study purposes. Participants randomized to the use of an ePlatform in&#xD;
      combination with a pedometer and digital scale will have data uploaded onto a secure&#xD;
      cloud-based platform controlled by the pedometer and digital scale companies.&#xD;
&#xD;
      HEALTH PROFESSIONAL COACH Participants randomized to the health coach strategy (i.e., 50% of&#xD;
      participants) will work by telephone and email with a health coach. The coach will be a&#xD;
      health professional hired through the study (dietitian/kinesiologist/nurse). On a weekly&#xD;
      basis, She/he will contact the participant to discuss progress and challenges in terms of&#xD;
      achieving physical activity goals, rate of GWG, and maintaining health eating patterns.&#xD;
      She/he will respond to specific questions on strategies and interplay between health&#xD;
      behaviours and parameters such as blood glucose and blood pressure levels. She/he may enquire&#xD;
      about any problems associated with higher physical activity levels such as contractions or&#xD;
      lower blood sugar levels, and will advise participants accordingly and consult with the&#xD;
      treating physician. Participants not randomized to a coaching strategy will be advised to&#xD;
      consult with their treating healthcare team directly if they develop symptoms of concern.&#xD;
&#xD;
      Fifty percent of participants will be randomized to a health coach. In turn, half of these&#xD;
      participants will also be randomized to the ePlatform with sensors strategy. The health&#xD;
      coaching approach will slightly differ between those randomized to the health coach &amp;&#xD;
      ePlatform with biosensors strategy vs. those randomized to the health coach without ePlatform&#xD;
      strategy.&#xD;
&#xD;
      For those randomized to the health coach &amp; ePlatform with biosensors strategy, the health&#xD;
      coach will have access to the data on the ePlatform. This data transfer is termed facilitated&#xD;
      relay, the exchange of patient collected health data between patients and providers outside&#xD;
      of traditional clinic visits (i.e., electronic and web-based sharing).&#xD;
&#xD;
      Participants randomized to both the ePlatform and the health coach will receive telephone&#xD;
      calls from the research assistant/health coach if they are off target despite the platform&#xD;
      tools and support. They will be encouraged to consult the resource bank and will brainstorm&#xD;
      with the health coach to decide how to achieve their GWG and step count targets.&#xD;
&#xD;
      Participants randomized to the health coach without the ePlatform will receive weekly calls&#xD;
      from the health coach, encouraging them to engage in healthy eating practices and aim to&#xD;
      achieve the GWG targets recommended by the Institute of Medicine (IOM). They will be&#xD;
      encouraged to track their weight gain and physical activity (e.g., walks, gym sessions,&#xD;
      classes, activity lists, etc.) and to share this information with the health coach for&#xD;
      discussion. However, they will not have access to the study ePlatform and will not be&#xD;
      provided with pedometers or digital scales.&#xD;
&#xD;
      At least one coach will be trained for each of the recruitment sites (5). The training will&#xD;
      consist of completion of 5 30-minute on-line modules supplemented by teleconferences with our&#xD;
      team of experts in health behaviour change (J Fowles, C Shields, C Chan, A-S Brazeau, D Da&#xD;
      Costa, K Dasgupta). The on-line training modules for health coaches address motivational&#xD;
      communication, key content areas (GDM, health behaviours, stress management), review the bank&#xD;
      of resources, discusses the decision trees/algorithms that will create triggers and alerts,&#xD;
      and demonstrates navigation of the ePlatform.&#xD;
&#xD;
      SETTING GDM clinics in Montreal (McGill University Health Centre/MUHC with Dr Sara Meltzer,&#xD;
      Dr Natasha Garfield, and Dr Rachel Bond; and Centre hospitalier de l'Université de&#xD;
      Montréal/CHUM with Dr Ariane Godbout and colleagues), Toronto (Sunnybrook Health Sciences&#xD;
      Centre with Dr Illana Halparin, Dr Baiju Shah, and colleagues), Calgary (Rockyview General&#xD;
      Hospital with Dr Sonia Butalia and colleagues), Winnipeg (Health Sciences Centre Winnipeg&#xD;
      with Dr P Katz and colleagues), and Halifax (Queen Elizabeth II Health Sciences Centre with&#xD;
      Dr Tom Ransom and colleagues).&#xD;
&#xD;
      RECRUITMENT GDM clinic staff will invite potentially eligible patients to consider&#xD;
      participation. With their permission, contact information will be forwarded to the local&#xD;
      ACTIVE PATIENT GDM research assistant. She/he will communicate with the participant to review&#xD;
      study procedures and obtain informed consent through an on-line form and telephone&#xD;
      conversation. The investigators aim to recruit and enroll at least 5 participants per month&#xD;
      per site.&#xD;
&#xD;
      ELIGIBILITY CRITERIA See relevant section&#xD;
&#xD;
      RUN-IN PHASE AND RANDOMIZATION Participants will receive instructions to log onto an&#xD;
      electronic platform. This will allow them to view a brief video on GDM-related complications.&#xD;
      If the participant logs onto the system within a week of baseline assessment, web-based&#xD;
      randomization will be performed. The participant will be encouraged to call or email the&#xD;
      research assistant if there is difficulty logging on.&#xD;
&#xD;
      DATA COLLECTION See outcomes for baseline and final data collected&#xD;
&#xD;
      SAMPLE SIZE The investigators will recruit 225 participants across 5 cities, resulting in up&#xD;
      to 45 participants per city over 9 months (to allow for 3 month intervention periods) or 5&#xD;
      participants per city per month. The present study is not designed to assess for between-arm&#xD;
      differences in GWG or LGA status of the offspring. The intent is to gather experience with&#xD;
      logistical procedures, participant perspectives, and estimates of indicators of feasibility.&#xD;
&#xD;
      INCENTIVES On three occasions (completion of the questionnaire at the beginning of the study,&#xD;
      completion of the questionnaire and interview before delivery, and completion of the&#xD;
      questionnaire and interview 12 weeks after delivery), participants will receive a $20 gift&#xD;
      card.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 29, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Factorial Assignment</intervention_model>
    <intervention_model_description>This is a feasibility (pilot) interventional study with a factorial design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is a behavioural intervention study. The participant, care provider, and investigator cannot be masked. Outcomes being assessed are objective (weight, steps, etc.) or are participant perspectives that preclude masking. Allocation is concealed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of candidates with GDM who accept to participate in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of resource bank</measure>
    <time_frame>12 weeks</time_frame>
    <description>Log-ins per participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived utility of resource bank</measure>
    <time_frame>12 weeks</time_frame>
    <description>Post intervention interview. a) What did the participant like about the website resources? b) What did the participant not like about the website? c) Prompts- Did the participant have difficulty logging on? Did the participant have difficulty navigating the site? Did the participant understand the information provided? Did the resource help to motivate the participant?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step count data</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of days step count data uploaded in ePlatform arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digital weight data</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of days weight data uploaded in ePlatform arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived utility of step count monitoring with ePlatform support</measure>
    <time_frame>12 weeks</time_frame>
    <description>Post intervention interview. a) Did the participant find it useful to track her step counts? What was useful about it? b) Did the participant find it burdensome to track her step counts? What was burdensome about it? e) Was it easy or was it difficult to use the ePlatform to upload data and review steps and weights? f) Did the participant like the messages from the ePlatform or were they an annoyance? g) Did the participant have any difficulties using a pedometer?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived utility of weight monitoring with ePlatform support</measure>
    <time_frame>12 weeks</time_frame>
    <description>Postintervention interview. c) Did the participant find it useful to track her weight? Why? d) Did the participant find it burdensome to track her weight? Why? e) Was it easy or was it difficult to use the ePlatform to upload data and review steps and weights? h) Did the participant have any difficulties using the digital scale?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of planned weekly conversations completed with health coach</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of weeks with health coach contact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived utility of health coaching conversations</measure>
    <time_frame>12 weeks</time_frame>
    <description>Postintervention interview. a) Did the participant find it useful to have a health coach? What was useful about it? b) Was it burdensome to have a health coach? What was burdensome? c) Prompts- Was it easy to find a time to speak with the coach? Were the conversations long enough? Were the conversations too long? What did the participant talk about? Was the information useful? Did the participant feel more motivated by having these conversations?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of evaluation procedures</measure>
    <time_frame>12 weeks</time_frame>
    <description>Evaluation metrics will be obtained through in-clinic assessments, on-line questionnaires, chart review, and telephone/Skype-based interviews.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Objective physical activity assessment. At baseline, all participants will be asked to wear a pedometer Piezo Rx(D) with concealed window for a 1-week period.The pedometer will be mailed to the site research assistant in the mailed and stamped envelope provided with an unused pedometer to correct for steps registered during mailing. At two to three weeks before the expected date of delivery or planned date of C-section or 36 weeks' gestation (whichever is first), the 1-week measurement procedure will be repeated. If the participant was in a group that was asked to use a pedometer during the study, she will not need to wear the pedometer with a tamper-proof seal. The participant will continue to use their usual pedometer.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational weight gain (GWG)</measure>
    <time_frame>12 weeks</time_frame>
    <description>All prenatal visit weights will be recorded from the medical paper or electronic chart or entered directly onto our data collection forms by the research assistant or collaborating physician. Participants will be weighed at all clinic visits by the research assistant or collaborating physician. GWG per week will be calculated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood pressure will be assessed at clinic visits by the research assistant or collaborating physician. From 6 automated measurements, the latter 5 systolic and diastolic measures will be separately averaged</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Mean glucose levels (before and after meals, at bedtime) will be abstracted at each clinic visit based on participant records</description>
  </other_outcome>
  <other_outcome>
    <measure>Content of conversations with health coach</measure>
    <time_frame>12 weeks</time_frame>
    <description>Health coaches will maintain a log of communications with study participants to allow us to ascertain the frequency and nature of communications as well as the overall time required.</description>
  </other_outcome>
  <other_outcome>
    <measure>Offspring birthweight percentile</measure>
    <time_frame>at birth</time_frame>
    <description>Chart review. Offspring birthweight, length, sex. Will be used to classify as large, small, or appropriate for gestational age</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational age at birth</measure>
    <time_frame>at birth</time_frame>
    <description>Chart review</description>
  </other_outcome>
  <other_outcome>
    <measure>Delivery method</measure>
    <time_frame>at birth</time_frame>
    <description>Chart review.</description>
  </other_outcome>
  <other_outcome>
    <measure>Apgar score</measure>
    <time_frame>at birth</time_frame>
    <description>Chart review</description>
  </other_outcome>
  <other_outcome>
    <measure>Completion of postpartum screen for diabetes</measure>
    <time_frame>12 weeks' postpartum</time_frame>
    <description>Completion of oral glucose tolerance testing. Ascertained by phone interview at 12 weeks' postpartum</description>
  </other_outcome>
  <other_outcome>
    <measure>Breastfeeding</measure>
    <time_frame>12 weeks' postpartum</time_frame>
    <description>Ascertained by phone interview. Between the birth of the participant's baby and now, how have has the participant been feeding her baby?&#xD;
Breastfeeding alone: Specify number of weeks or days&#xD;
Formula feeding alone: Specify number of weeks or days&#xD;
Mix of the two: Specify number of weeks or days</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Resource bank</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The web-based resource bank includes information and perspectives about GDM, nutrition, and physical activity. The information is presented through video capsules, on-line text, printable pdfs, and podcasts. It is presented by health care professionals and patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resource bank and ePlatform</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to resource bank access, participants will receive a digital scale, physical activity monitor (pedometer), and ePlatform log-in information. They will track daily weights and step counts. They will receive prompts to access educational and motivational tools based on the data that they enter and whether or not they enter data. The investigators will use the ePlatform developed by StepsCount, a Canadian pedometer company with a well-developed ePlatform for pedometer data upload, tracking, and automated messaging. The company is permitting us further customization for study purposes. Data will be uploaded onto a secure cloud-based platform controlled by the pedometer and digital scale companies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resource bank and health coach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to resource bank access, the coach will contact the participant weekly (telephone, text, email) to discuss progress and challenges in terms of achieving physical activity goals, rate of GWG, and maintaining health eating patterns, as well as any concerns.Participants not randomized to a coaching strategy will be advised to consult with their treating healthcare team directly if they develop symptoms of concern.&#xD;
The coach will encourage participants to track their weight gain and physical activity (e.g., walks, classes, activity lists, etc.) and to share this information. However, they will not have access to the study ePlatform and will not be provided with pedometers or digital scales.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resource bank with ePlatform and coach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have resource bank access as well as ePlatform and coaching interventions.The health coach will have access to the data on the ePlatform. They will receive telephone calls from the research assistant/health coach if they are off target despite the platform tools and support. They will be encouraged to consult the resource bank and will brainstorm with the health coach to decide how to achieve their GWG and step count targets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resource bank</intervention_name>
    <description>See intervention arm descriptions</description>
    <arm_group_label>Resource bank</arm_group_label>
    <arm_group_label>Resource bank and ePlatform</arm_group_label>
    <arm_group_label>Resource bank and health coach</arm_group_label>
    <arm_group_label>Resource bank with ePlatform and coach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ePlatform</intervention_name>
    <description>See intervention arm descriptions</description>
    <arm_group_label>Resource bank and ePlatform</arm_group_label>
    <arm_group_label>Resource bank with ePlatform and coach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health coach</intervention_name>
    <description>See intervention arm descriptions</description>
    <arm_group_label>Resource bank and health coach</arm_group_label>
    <arm_group_label>Resource bank with ePlatform and coach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Followed by a ACTIVE patient GDM collaborating doctor&#xD;
&#xD;
          -  Currently diagnosed with gestational diabetes&#xD;
&#xD;
          -  At 24 to 28 weeks during pregnancy&#xD;
&#xD;
          -  Conversant in either English or French&#xD;
&#xD;
          -  Have frequent access to a Smartphone (iPhone iOS 10.0 or Android version 5.0 or&#xD;
             higher) with WIFI capabilities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or diagnosis of diabetes type 1 or 2&#xD;
&#xD;
          -  Currently pregnant with more than one child&#xD;
&#xD;
          -  Planning to give birth at a place other than the hospital&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Conditions that are absolute contraindications for exercise during pregnancy&#xD;
             (Restrictive lung disease, ruptured membranes, pre-eclampsia, pregnancy-induced&#xD;
             hypertension, Premature labour during current pregnancy, persistent bleeding,&#xD;
             incomplete cervix, placenta previa, Hemodynamically significant heart disease)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This study is looking at the effects of interventions on pregnant women with gestational diabetes</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaberi Dasgupta, MD, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Debbie Chan, BSc</last_name>
    <phone>514-934-1934</phone>
    <phone_ext>1X44835</phone_ext>
    <email>debbie.chan@rimuhc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kaberi Dasgupta, MD, MSc</last_name>
    <email>kaberi.dasgupta@mcgill.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Leung Hui, RD, PhD</last_name>
      <phone>204-789-3985</phone>
      <email>Amy.Hui@umanitoba.ca</email>
    </contact>
    <investigator>
      <last_name>Garry Shen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IWK Helath Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Akbari</last_name>
      <phone>902-470-7158</phone>
      <email>Mary.Akbari@iwk.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Jillian Coolen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kainat Amir, BSc</last_name>
      <phone>416-480-6100</phone>
      <phone_ext>87703</phone_ext>
      <email>kainat.amir@sri.utoronto.ca</email>
    </contact>
    <investigator>
      <last_name>Ilana J Halperin, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Baiju Shah, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debbie Chan, BSc</last_name>
      <phone>514-934-1934</phone>
      <phone_ext>44835</phone_ext>
      <email>debbie.chan@rimuhc.ca</email>
    </contact>
    <investigator>
      <last_name>Tricia Peters, MD MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debbie Chan, BSc</last_name>
      <phone>514-934-1934</phone>
      <phone_ext>44835</phone_ext>
      <email>debbie.chan@rimuhc.ca</email>
    </contact>
    <investigator>
      <last_name>Sara Meltzer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Natasha Garfield, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachel Bond, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Kaberi Dasgupta, MD, MSc, FRCP (C)</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, McGill University; Physician Scientist and Director, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre (RI-MUHC)</investigator_title>
  </responsible_party>
  <keyword>gestational weight gain</keyword>
  <keyword>large for gestational age status</keyword>
  <keyword>step counts</keyword>
  <keyword>physical activity</keyword>
  <keyword>health coaching</keyword>
  <keyword>ePlatform</keyword>
  <keyword>pedometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802877
org study id: GRT 2017-16
nct id: NCT03802877
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Among women with GDM, the investigators will determine if a strategy of (1) a website-based
      information and motivational resource bank; (2) biosensor/ePlatform-based physical activity
      and GWG tracking; and/or (3) a health coach will lead to more favourably outcomes; namely,
      GWG closer to target, higher physical activity levels, better glycemic and blood pressure
      control, and lower incidence of LGA in offspring.

      The current project is designed to assess feasibility and usability to inform the development
      of a large randomized controlled trial. The investigators will monitor the implementation
      process and examine patient-oriented outcomes, including perceptions of utility, challenges,
      and burden. These will be assessed through telephone-based in-depth interview.

      Methodology / Study design This is a feasibility randomized controlled trial with a factorial
      design. The investigators will recruit women with a diagnosis of GDM between 24 and 28 weeks'
      pregnancy. All will receive access to a website resource bank with tips and resources to
      optimize physical activity and dietary intake a quality during pregnancy. In addition, they
      will be randomized to one of the four following groups: (1) No additional intervention; (2)
      ePlatform-based automated support combined with pedometer-based physical activity monitoring
      and digital scale-based weight monitoring; (3) weekly telephone calls with a health coach to
      discuss physical activity, eating, gestational weight gain; (4) combination of ePlatform and
      telephone calls from a health coach.

      The investigators will evaluate recruitment rates, drop-out rates, women's perceptions of the
      strengths and limitations of the strategy, and ease and feasibility of outcome assessment.
      Assessments will be through in-clinic assessments, on-line questionnaires, clinic-based
      measures, mailed-in pedometers, and telephone-based interviews. Assessments will be at study
      entry and two to three weeks before the expected date of delivery or date of scheduled
      C-section. There will be a telephone-based interview at 12 weeks postpartum.
Our overarching aim is to determine, among women with gestational diabetes (GDM), if a
      strategy of (1) a website-based information and motivational resource bank; (2)
      biosensor/ePlatform-based physical activity and gestational weight gain (GWG) tracking;
      and/or (3) a health coach will lead to more favourable outcomes; namely, GWG closer to
      target, higher physical activity levels, better glycemic and blood pressure control, and
      lower incidence of large for gestational age (LGA) in offspring.

      The current project is designed to assess feasibility and usability to inform the development
      of a large randomized controlled trial. The specific aims of this feasibility study are:

        1. To determine the proportion of candidates with GDM who accept to participate in the
           study at each site (recruitment rates); a minimum overall average recruitment rate of
           25/month would favour proceeding to a larger trial.

        2. To evaluate participant use (log ins) and perceived utility (interviews) of the website
           resource that the investigators are developing; a minimum average of 5 log-ins overall
           would favour proceeding to a larger trial

        3. To determine use (number of planned weekly conversations completed) and perceived
           utility (interviews) of the health coaching intervention; a minimum completion of 50% of
           the planned weekly conversations would favour retaining this treatment arm in a larger
           trial

        4. To determine use (data upload of step counts and weight data onto ePlatform) and
           perceived utility (interviews) of the ePlatform intervention ; a minimal upload of 30%
           of days overall of data would favour retaining this treatment arm in a larger trial

        5. To assess the proportion of participants in each intervention arm who complete final
           evaluation procedures (loss to follow-up rates); a minimum retention of 75% of
           participants enrolled would favour execution of a larger clinical trial

      DESIGN Lawson ACTIVE PATIENT has a 2X2 factorial design. All participants will have access to
      the information and motivational resource bank, housed on a dedicated study website. Each
      participant will be randomized (1) to an ePlatform yes/no strategy and (2) to a health coach
      yes/no strategy. Therefore, some participants will have access to the website only, others to
      the website & ePlatform, others to the website & coach, and some to the website, ePlatform &
      coach. By interviewing and surveying participants in each of these groups, the investigators
      will be able to ascertain if there are components that are redundant or synergistic.

      RESOURCE BANK The website sections include (1) 'About' with an overview about GDM, its
      management, and its complications; (2) 'Perspectives' with video and audio clips and
      interviews with mothers with a GDM history, physicians, dietitians, and kinesiologists, all
      describing their experiences living with or managing GDM and highlighting the importance of
      attending to this condition both during pregnancy and thereafter; (3) 'Nutrition' with
      descriptions and discussion of impact of eating on glucose control, illustration of the
      'healthy plate' concepts, grocery shopping tips, links to healthy recipe banks, a
      photographic repository of health snack ideas, healthy lunches, and healthy breakfasts; (4)
      'Activity' with explanations for pedometer use, step count targets, physical activity
      targets, step and physical activity monitoring, links to exercise video clips, precautions
      during pregnancy; and (5) 'Postpartum' which will include future diabetes risk facts relevant
      to mothers, fathers, and children; diabetes prevention approaches; and planning for future
      pregnancies.

      ePLATFORM WITH SENSORS Participants randomized to the ePlatform strategy (i.e., 50% of
      participants) will receive a digital scale, physical activity monitor (pedometer), and
      ePlatform log-in information. They will track daily weights and step counts. They will
      receive prompts to access educational and motivational tools based on the data that they
      enter and whether or not they enter data. The investigators will use the ePlatform developed
      by StepsCount, a Canadian pedometer company with a well-developed ePlatform for pedometer
      data upload, tracking, and automated messaging. The company is permitting us further
      customization for study purposes. Participants randomized to the use of an ePlatform in
      combination with a pedometer and digital scale will have data uploaded onto a secure
      cloud-based platform controlled by the pedometer and digital scale companies.

      HEALTH PROFESSIONAL COACH Participants randomized to the health coach strategy (i.e., 50% of
      participants) will work by telephone and email with a health coach. The coach will be a
      health professional hired through the study (dietitian/kinesiologist/nurse). On a weekly
      basis, She/he will contact the participant to discuss progress and challenges in terms of
      achieving physical activity goals, rate of GWG, and maintaining health eating patterns.
      She/he will respond to specific questions on strategies and interplay between health
      behaviours and parameters such as blood glucose and blood pressure levels. She/he may enquire
      about any problems associated with higher physical activity levels such as contractions or
      lower blood sugar levels, and will advise participants accordingly and consult with the
      treating physician. Participants not randomized to a coaching strategy will be advised to
      consult with their treating healthcare team directly if they develop symptoms of concern.

      Fifty percent of participants will be randomized to a health coach. In turn, half of these
      participants will also be randomized to the ePlatform with sensors strategy. The health
      coaching approach will slightly differ between those randomized to the health coach &
      ePlatform with biosensors strategy vs. those randomized to the health coach without ePlatform
      strategy.

      For those randomized to the health coach & ePlatform with biosensors strategy, the health
      coach will have access to the data on the ePlatform. This data transfer is termed facilitated
      relay, the exchange of patient collected health data between patients and providers outside
      of traditional clinic visits (i.e., electronic and web-based sharing).

      Participants randomized to both the ePlatform and the health coach will receive telephone
      calls from the research assistant/health coach if they are off target despite the platform
      tools and support. They will be encouraged to consult the resource bank and will brainstorm
      with the health coach to decide how to achieve their GWG and step count targets.

      Participants randomized to the health coach without the ePlatform will receive weekly calls
      from the health coach, encouraging them to engage in healthy eating practices and aim to
      achieve the GWG targets recommended by the Institute of Medicine (IOM). They will be
      encouraged to track their weight gain and physical activity (e.g., walks, gym sessions,
      classes, activity lists, etc.) and to share this information with the health coach for
      discussion. However, they will not have access to the study ePlatform and will not be
      provided with pedometers or digital scales.

      At least one coach will be trained for each of the recruitment sites (5). The training will
      consist of completion of 5 30-minute on-line modules supplemented by teleconferences with our
      team of experts in health behaviour change (J Fowles, C Shields, C Chan, A-S Brazeau, D Da
      Costa, K Dasgupta). The on-line training modules for health coaches address motivational
      communication, key content areas (GDM, health behaviours, stress management), review the bank
      of resources, discusses the decision trees/algorithms that will create triggers and alerts,
      and demonstrates navigation of the ePlatform.

      SETTING GDM clinics in Montreal (McGill University Health Centre/MUHC with Dr Sara Meltzer,
      Dr Natasha Garfield, and Dr Rachel Bond; and Centre hospitalier de l'Université de
      Montréal/CHUM with Dr Ariane Godbout and colleagues), Toronto (Sunnybrook Health Sciences
      Centre with Dr Illana Halparin, Dr Baiju Shah, and colleagues), Calgary (Rockyview General
      Hospital with Dr Sonia Butalia and colleagues), Winnipeg (Health Sciences Centre Winnipeg
      with Dr P Katz and colleagues), and Halifax (Queen Elizabeth II Health Sciences Centre with
      Dr Tom Ransom and colleagues).

      RECRUITMENT GDM clinic staff will invite potentially eligible patients to consider
      participation. With their permission, contact information will be forwarded to the local
      ACTIVE PATIENT GDM research assistant. She/he will communicate with the participant to review
      study procedures and obtain informed consent through an on-line form and telephone
      conversation. The investigators aim to recruit and enroll at least 5 participants per month
      per site.

      ELIGIBILITY CRITERIA See relevant section

      RUN-IN PHASE AND RANDOMIZATION Participants will receive instructions to log onto an
      electronic platform. This will allow them to view a brief video on GDM-related complications.
      If the participant logs onto the system within a week of baseline assessment, web-based
      randomization will be performed. The participant will be encouraged to call or email the
      research assistant if there is difficulty logging on.

      DATA COLLECTION See outcomes for baseline and final data collected

      SAMPLE SIZE The investigators will recruit 225 participants across 5 cities, resulting in up
      to 45 participants per city over 9 months (to allow for 3 month intervention periods) or 5
      participants per city per month. The present study is not designed to assess for between-arm
      differences in GWG or LGA status of the offspring. The intent is to gather experience with
      logistical procedures, participant perspectives, and estimates of indicators of feasibility.

      INCENTIVES On three occasions (completion of the questionnaire at the beginning of the study,
      completion of the questionnaire and interview before delivery, and completion of the
      questionnaire and interview 12 weeks after delivery), participants will receive a $20 gift
      card.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This is a feasibility (pilot) interventional study with a factorial design
primary purpose: Treatment
masking: None (Open Label)
masking description: This is a behavioural intervention study. The participant, care provider, and investigator cannot be masked. Outcomes being assessed are objective (weight, steps, etc.) or are participant perspectives that preclude masking. Allocation is concealed.
measure: Recruitment
time frame: 1 year
description: Proportion of candidates with GDM who accept to participate in the study
measure: Use of resource bank
time frame: 12 weeks
description: Log-ins per participant
measure: Perceived utility of resource bank
time frame: 12 weeks
description: Post intervention interview. a) What did the participant like about the website resources? b) What did the participant not like about the website? c) Prompts- Did the participant have difficulty logging on? Did the participant have difficulty navigating the site? Did the participant understand the information provided? Did the resource help to motivate the participant?
measure: Step count data
time frame: 12 weeks
description: Percent of days step count data uploaded in ePlatform arm
measure: Digital weight data
time frame: 12 weeks
description: Percent of days weight data uploaded in ePlatform arm
measure: Perceived utility of step count monitoring with ePlatform support
time frame: 12 weeks
description: Post intervention interview. a) Did the participant find it useful to track her step counts? What was useful about it? b) Did the participant find it burdensome to track her step counts? What was burdensome about it? e) Was it easy or was it difficult to use the ePlatform to upload data and review steps and weights? f) Did the participant like the messages from the ePlatform or were they an annoyance? g) Did the participant have any difficulties using a pedometer?
measure: Perceived utility of weight monitoring with ePlatform support
time frame: 12 weeks
description: Postintervention interview. c) Did the participant find it useful to track her weight? Why? d) Did the participant find it burdensome to track her weight? Why? e) Was it easy or was it difficult to use the ePlatform to upload data and review steps and weights? h) Did the participant have any difficulties using the digital scale?
measure: Number of planned weekly conversations completed with health coach
time frame: 12 weeks
description: Percent of weeks with health coach contact
measure: Perceived utility of health coaching conversations
time frame: 12 weeks
description: Postintervention interview. a) Did the participant find it useful to have a health coach? What was useful about it? b) Was it burdensome to have a health coach? What was burdensome? c) Prompts- Was it easy to find a time to speak with the coach? Were the conversations long enough? Were the conversations too long? What did the participant talk about? Was the information useful? Did the participant feel more motivated by having these conversations?
measure: Completion of evaluation procedures
time frame: 12 weeks
description: Evaluation metrics will be obtained through in-clinic assessments, on-line questionnaires, chart review, and telephone/Skype-based interviews.
measure: Change in physical activity
time frame: 12 weeks
description: Objective physical activity assessment. At baseline, all participants will be asked to wear a pedometer Piezo Rx(D) with concealed window for a 1-week period.The pedometer will be mailed to the site research assistant in the mailed and stamped envelope provided with an unused pedometer to correct for steps registered during mailing. At two to three weeks before the expected date of delivery or planned date of C-section or 36 weeks' gestation (whichever is first), the 1-week measurement procedure will be repeated. If the participant was in a group that was asked to use a pedometer during the study, she will not need to wear the pedometer with a tamper-proof seal. The participant will continue to use their usual pedometer.
measure: Gestational weight gain (GWG)
time frame: 12 weeks
description: All prenatal visit weights will be recorded from the medical paper or electronic chart or entered directly onto our data collection forms by the research assistant or collaborating physician. Participants will be weighed at all clinic visits by the research assistant or collaborating physician. GWG per week will be calculated.
measure: Blood pressure
time frame: 12 weeks
description: Blood pressure will be assessed at clinic visits by the research assistant or collaborating physician. From 6 automated measurements, the latter 5 systolic and diastolic measures will be separately averaged
measure: Glucose levels
time frame: 12 weeks
description: Mean glucose levels (before and after meals, at bedtime) will be abstracted at each clinic visit based on participant records
measure: Content of conversations with health coach
time frame: 12 weeks
description: Health coaches will maintain a log of communications with study participants to allow us to ascertain the frequency and nature of communications as well as the overall time required.
measure: Offspring birthweight percentile
time frame: at birth
description: Chart review. Offspring birthweight, length, sex. Will be used to classify as large, small, or appropriate for gestational age
measure: Gestational age at birth
time frame: at birth
description: Chart review
measure: Delivery method
time frame: at birth
description: Chart review.
measure: Apgar score
time frame: at birth
description: Chart review
measure: Completion of postpartum screen for diabetes
time frame: 12 weeks' postpartum
description: Completion of oral glucose tolerance testing. Ascertained by phone interview at 12 weeks' postpartum
measure: Breastfeeding
time frame: 12 weeks' postpartum
description: Ascertained by phone interview. Between the birth of the participant's baby and now, how have has the participant been feeding her baby?
Breastfeeding alone: Specify number of weeks or days
Formula feeding alone: Specify number of weeks or days
Mix of the two: Specify number of weeks or days
arm group label: Resource bank
arm group type: Active Comparator
description: The web-based resource bank includes information and perspectives about GDM, nutrition, and physical activity. The information is presented through video capsules, on-line text, printable pdfs, and podcasts. It is presented by health care professionals and patients.
arm group label: Resource bank and ePlatform
arm group type: Experimental
description: In addition to resource bank access, participants will receive a digital scale, physical activity monitor (pedometer), and ePlatform log-in information. They will track daily weights and step counts. They will receive prompts to access educational and motivational tools based on the data that they enter and whether or not they enter data. The investigators will use the ePlatform developed by StepsCount, a Canadian pedometer company with a well-developed ePlatform for pedometer data upload, tracking, and automated messaging. The company is permitting us further customization for study purposes. Data will be uploaded onto a secure cloud-based platform controlled by the pedometer and digital scale companies.
arm group label: Resource bank and health coach
arm group type: Experimental
description: In addition to resource bank access, the coach will contact the participant weekly (telephone, text, email) to discuss progress and challenges in terms of achieving physical activity goals, rate of GWG, and maintaining health eating patterns, as well as any concerns.Participants not randomized to a coaching strategy will be advised to consult with their treating healthcare team directly if they develop symptoms of concern.
The coach will encourage participants to track their weight gain and physical activity (e.g., walks, classes, activity lists, etc.) and to share this information. However, they will not have access to the study ePlatform and will not be provided with pedometers or digital scales.
arm group label: Resource bank with ePlatform and coach
arm group type: Experimental
description: Participants will have resource bank access as well as ePlatform and coaching interventions.The health coach will have access to the data on the ePlatform. They will receive telephone calls from the research assistant/health coach if they are off target despite the platform tools and support. They will be encouraged to consult the resource bank and will brainstorm with the health coach to decide how to achieve their GWG and step count targets.
intervention type: Behavioral
intervention name: Resource bank
description: See intervention arm descriptions
arm group label: Resource bank
arm group label: Resource bank and ePlatform
arm group label: Resource bank and health coach
arm group label: Resource bank with ePlatform and coach
intervention type: Behavioral
intervention name: ePlatform
description: See intervention arm descriptions
arm group label: Resource bank and ePlatform
arm group label: Resource bank with ePlatform and coach
intervention type: Behavioral
intervention name: Health coach
description: See intervention arm descriptions
arm group label: Resource bank and health coach
arm group label: Resource bank with ePlatform and coach
criteria: 
gender: Female
gender based: Yes
gender description: This study is looking at the effects of interventions on pregnant women with gestational diabetes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kaberi Dasgupta, MD, MSC
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
last name: Debbie Chan, BSc
phone: 514-934-1934
phone ext: 1X44835
email: debbie.chan@rimuhc.ca
last name: Kaberi Dasgupta, MD, MSc
email: kaberi.dasgupta@mcgill.ca
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Kaberi Dasgupta, MD, MSc, FRCP (C)
investigator title: Associate Professor of Medicine, McGill University; Physician Scientist and Director, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre (RI-MUHC)
mesh term: Diabetes, Gestational