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Digital Health Interventions for Gestational Diabetes

N/A
Waitlist Available
Led By Kaberi Dasgupta, MD, MSC
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently diagnosed with gestational diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is designed to assess the feasibility and usability of different interventions to help pregnant women with GDM to better control their weight, activity levels, and blood sugar, with the goal of reducing the incidence of LGA in their offspring.

Who is the study for?
This trial is for women with gestational diabetes, between 20 and less than 32 weeks pregnant, followed by a specific doctor group, who speak English or French and have regular access to a modern smartphone. It excludes those with other types of diabetes, multiple pregnancies, non-hospital birth plans, smokers, or conditions that limit exercise during pregnancy.Check my eligibility
What is being tested?
The study tests if a web-based resource bank, biosensor/ePlatform tracking physical activity and weight gain during pregnancy (GWG), or weekly health coach calls can improve outcomes like GWG control and lower large-for-gestational-age (LGA) offspring incidence. Participants are randomly assigned to one of four groups including these interventions in different combinations.See study design
What are the potential side effects?
Since the interventions involve informational resources and lifestyle coaching rather than medications or medical procedures, typical drug-related side effects are not expected. However, participants may experience stress or discomfort related to frequent monitoring and lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with diabetes during my pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recruitment
Secondary outcome measures
Completion of evaluation procedures
Digital weight data
Number of planned weekly conversations completed with health coach
+6 more
Other outcome measures
Apgar score
Blood pressure
Breastfeeding
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Resource bank with ePlatform and coachExperimental Treatment3 Interventions
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.
Group II: Resource bank and health coachExperimental Treatment2 Interventions
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.
Group III: Resource bank and ePlatformExperimental Treatment2 Interventions
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.
Group IV: Resource bankActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

The Lawson FoundationOTHER
15 Previous Clinical Trials
3,755 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,499 Total Patients Enrolled
Kaberi Dasgupta, MD, MSCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous sites offering this clinical experiment in the metropolitan area?

"At this moment, the trial is recruiting patients from 5 distinct sites. The main cities are Halifax, Montreal and Winnipeg with additional locations in other urban centres. We advise choosing a nearby site to reduce travel demands should you choose to enter the study."

Answered by AI

What is the maximum capacity for participants in this research initiative?

"This trial necessitates the enrollment of 225 eligible patients. Both IWK Helath Centre in Halifax, Nova Scotia and Jewish General Hospital in Montreal are involved in running this study."

Answered by AI

Are applications still being taken for this medical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial was initially posted on August 29th 2019 and is still actively searching for 225 participants from 5 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Active Patient GDM
Kaberi Dasgupta, MD, MSc, FRCP (C) 2019. "Active Patient GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03802877.
~8 spots leftby Jun 2024
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