Digital Health Interventions for Gestational Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on digital health interventions for gestational diabetes, so it's best to discuss your medications with the trial team or your doctor.
What data supports the effectiveness of the treatment for gestational diabetes?
Research shows that digital health interventions, like mobile apps and health coaching, can help manage gestational diabetes by promoting healthy lifestyle choices and improving glucose levels. These tools have been effective in other conditions like type 2 diabetes, suggesting they can also be beneficial for gestational diabetes.12345
Is it safe to use digital health interventions for gestational diabetes?
How is the treatment 'Digital Health Interventions for Gestational Diabetes' different from other treatments for this condition?
What is the purpose of this trial?
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 20 and less than 32 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.
Research Team
Kaberi Dasgupta, MD, MSC
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive access to a website resource bank and are randomized to different intervention groups including ePlatform and health coaching.
Follow-up
Participants are monitored for outcomes such as gestational weight gain, physical activity, and health coaching effectiveness.
Postpartum Evaluation
Completion of postpartum screen for diabetes and assessment of breastfeeding practices.
Treatment Details
Interventions
- ePlatform
- Health coach
- Resource bank
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
The Lawson Foundation
Collaborator