Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Active Patient GDM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802877
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Resource bank Behavioral: ePlatform Behavioral: Health coach Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a feasibility (pilot) interventional study with a factorial design
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.
Primary Purpose: Treatment
Official Title: ACTIVating and Engaging PAtients Through Clinical Interaction Redesign and Electronically- Integrated Novel Technologies Gestational Diabetes
Actual Study Start Date : August 29, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resource bank
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.
Behavioral: Resource bank
See intervention arm descriptions

Experimental: Resource bank and ePlatform
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.
Behavioral: Resource bank
See intervention arm descriptions

Behavioral: ePlatform
See intervention arm descriptions

Experimental: Resource bank and health coach

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.

Behavioral: Resource bank
See intervention arm descriptions

Behavioral: Health coach
See intervention arm descriptions

Experimental: Resource bank with ePlatform and coach
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.
Behavioral: Resource bank
See intervention arm descriptions

Behavioral: ePlatform
See intervention arm descriptions

Behavioral: Health coach
See intervention arm descriptions




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 1 year ]
    Proportion of candidates with GDM who accept to participate in the study


Secondary Outcome Measures :
  1. Use of resource bank [ Time Frame: 12 weeks ]
    Log-ins per participant

  2. Perceived utility of resource bank [ Time Frame: 12 weeks ]
    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?

  3. Step count data [ Time Frame: 12 weeks ]
    Percent of days step count data uploaded in ePlatform arm

  4. Digital weight data [ Time Frame: 12 weeks ]
    Percent of days weight data uploaded in ePlatform arm

  5. Perceived utility of step count monitoring with ePlatform support [ Time Frame: 12 weeks ]
    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?

  6. Perceived utility of weight monitoring with ePlatform support [ Time Frame: 12 weeks ]
    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?

  7. Number of planned weekly conversations completed with health coach [ Time Frame: 12 weeks ]
    Percent of weeks with health coach contact

  8. Perceived utility of health coaching conversations [ Time Frame: 12 weeks ]
    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?

  9. Completion of evaluation procedures [ Time Frame: 12 weeks ]
    Evaluation metrics will be obtained through in-clinic assessments, on-line questionnaires, chart review, and telephone/Skype-based interviews.


Other Outcome Measures:
  1. Change in physical activity [ Time Frame: 12 weeks ]
    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.

  2. Gestational weight gain (GWG) [ Time Frame: 12 weeks ]
    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.

  3. Blood pressure [ Time Frame: 12 weeks ]
    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

  4. Glucose levels [ Time Frame: 12 weeks ]
    Mean glucose levels (before and after meals, at bedtime) will be abstracted at each clinic visit based on participant records

  5. Content of conversations with health coach [ Time Frame: 12 weeks ]
    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.

  6. Offspring birthweight percentile [ Time Frame: at birth ]
    Chart review. Offspring birthweight, length, sex. Will be used to classify as large, small, or appropriate for gestational age

  7. Gestational age at birth [ Time Frame: at birth ]
    Chart review

  8. Delivery method [ Time Frame: at birth ]
    Chart review.

  9. Apgar score [ Time Frame: at birth ]
    Chart review

  10. Completion of postpartum screen for diabetes [ Time Frame: 12 weeks' postpartum ]
    Completion of oral glucose tolerance testing. Ascertained by phone interview at 12 weeks' postpartum

  11. Breastfeeding [ Time Frame: 12 weeks' postpartum ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is looking at the effects of interventions on pregnant women with gestational diabetes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Followed by a ACTIVE patient GDM collaborating doctor
  • Currently diagnosed with gestational diabetes
  • At 24 to 28 weeks during pregnancy
  • Conversant in either English or French
  • Have frequent access to a Smartphone (iPhone iOS 10.0 or Android version 5.0 or higher) with WIFI capabilities

Exclusion Criteria:

  • History or diagnosis of diabetes type 1 or 2
  • Currently pregnant with more than one child
  • Planning to give birth at a place other than the hospital
  • Smokers
  • Conditions that are absolute contraindications for exercise during pregnancy (Restrictive lung disease, ruptured membranes, pre-eclampsia, pregnancy-induced hypertension, Premature labour during current pregnancy, persistent bleeding, incomplete cervix, placenta previa, Hemodynamically significant heart disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802877


Contacts
Layout table for location contacts
Contact: Debbie Chan, BSc 514-934-1934 ext 1X44835 debbie.chan@rimuhc.ca
Contact: Kaberi Dasgupta, MD, MSc kaberi.dasgupta@mcgill.ca

Locations
Layout table for location information
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Darlene Sola, BSc    403.210.6923    dsola@ucalgary.ca   
Principal Investigator: Sonia Butalia, MD, MSc         
Canada, Manitoba
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Amy Leung Hui, RD, PhD    204-789-3985    Amy.Hui@umanitoba.ca   
Principal Investigator: Garry Shen, MD, PhD         
Canada, Nova Scotia
IWK Helath Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Raquel Dias    902-470-7158    Raquel.Dias@iwk.nshealth.ca   
Principal Investigator: Jillian Coolen, MD         
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Veronica Gale, BSc RN    416-480-6100 ext 87703    veronica.gale@sri.utoronto.ca   
Principal Investigator: Ilana J Halperin, MD, MSc         
Sub-Investigator: Baiju Shah, MD, PhD         
Canada, Quebec
Centre hospitalier de l'Université de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2X 0C1
Contact: Debbie Chan         
Principal Investigator: Ariane Godbout, MD         
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Debbie Chan, BSc    514-934-1934 ext 44835      
Principal Investigator: Sara Meltzer, MD         
Sub-Investigator: Natasha Garfield, MD         
Sub-Investigator: Rachel Bond, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Lawson Foundation
Investigators
Layout table for investigator information
Principal Investigator: Kaberi Dasgupta, MD, MSC McGill University Health Centre/Research Institute of the McGill University Health Centre
Layout table for additonal information
Responsible Party: Kaberi Dasgupta, MD, MSc, FRCP (C), 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), McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03802877    
Other Study ID Numbers: GRT 2017-16
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre:
gestational weight gain
large for gestational age status
step counts
physical activity
health coaching
ePlatform
pedometer
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases