Digital Health Interventions for Gestational Diabetes

No longer recruiting at 6 trial locations

Overseen By Kaberi Dasgupta, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Diabetes type 1 or 2, Smokers, Multiple pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore digital health tools to help women with gestational diabetes manage their condition better during pregnancy. Researchers seek to determine if using a website for information, a digital platform (ePlatform) for tracking activity and weight, or regular health coach calls can improve outcomes like weight control and blood sugar levels. Women between 20 and less than 32 weeks pregnant with gestational diabetes who frequently access a smartphone might be a good fit for this study. Participants will be divided into groups to test different combinations of these tools. Feedback from participants will help shape a larger future study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance gestational diabetes management for future patients.

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 prior data suggests that these digital health interventions are safe for women with gestational diabetes?

Research has shown that digital health tools are safe for people with gestational diabetes (GDM). Studies have found that digital platforms effectively manage blood sugar levels without major safety issues. These tools often provide educational resources and track health data to improve outcomes.

Having a health coach for support also proves beneficial. Research suggests that health coaching aids in weight management and improves overall pregnancy outcomes for those with GDM. Reports of harmful effects from these methods are insignificant, indicating general safety.

Both digital platforms and health coaching have been well-received in past studies, with participants often finding them helpful and easy to use. This suggests these methods are not only safe but also practical for managing GDM. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital health interventions for gestational diabetes because they offer a more personalized and interactive approach compared to standard care options like dietary changes, exercise, and insulin. The ePlatform and health coach combination allows for real-time data tracking and personalized feedback, which can help expectant mothers better manage their weight gain and activity levels. Additionally, the resource bank provides comprehensive and easily accessible information through videos, podcasts, and articles, making it a versatile tool for patient education and empowerment. These digital tools provide a more supportive and continuous engagement, which could lead to better health outcomes for both mothers and their babies.

What evidence suggests that this trial's interventions could be effective for gestational diabetes?

This trial will evaluate various digital health interventions for gestational diabetes. Research has shown that digital health tools, such as online platforms, can help women with gestational diabetes manage their blood sugar more effectively. In this trial, some participants will access a resource bank and ePlatform, which includes tools for tracking weight and physical activity. Others will receive additional support from a health coach, who will provide guidance on exercise and healthy eating. Studies indicate that these tools can lead to healthier pregnancies and better control of blood sugar levels, which is essential for managing gestational diabetes. Together, these approaches aim to maintain healthy weight gain and improve overall health during pregnancy. ^{1 2 4 6 7}

Who Is on the Research Team?

Kaberi Dasgupta, MD, MSC

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

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

Have frequent access to a Smartphone (iPhone iOS 10.0 or Android version 5.0 or higher) with WIFI capabilities

I am between 20 and 31 weeks pregnant.

You are seeing a doctor who is actively treating your gestational diabetes.

Exclusion Criteria

I do not have any health conditions that make exercise during pregnancy unsafe.

I have been diagnosed with diabetes type 1 or 2.

Currently pregnant with more than one child

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive access to a website resource bank and are randomized to different intervention groups including ePlatform and health coaching.

12 weeks

Weekly interactions (telephone, email, or text)

Follow-up

Participants are monitored for outcomes such as gestational weight gain, physical activity, and health coaching effectiveness.

12 weeks postpartum

Telephone-based interview at 12 weeks postpartum

Postpartum Evaluation

Completion of postpartum screen for diabetes and assessment of breastfeeding practices.

12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• ePlatform
• Health coach
• Resource bank

Trial Overview 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.

How Is the Trial Designed?

Group I: Resource bank with ePlatform and coach Experimental Treatment 3 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 coach Experimental Treatment 2 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 ePlatform Experimental Treatment 2 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 bank Active Control 1 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.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

The Lawson Foundation

Collaborator

Trials

16

Recruited

4,000+

Published Research Related to This Trial

The 12-week Healthy at Home digital health coaching program significantly improved insulin resistance in individuals with type 2 diabetes, showing a reduction in HOMA2-IR scores compared to usual care (p = 0.029).

This pilot study suggests that digital health coaching can be an effective and accessible intervention for under-resourced patients with type 2 diabetes, potentially leading to better diabetes management and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. Azelton, KR., Crowley, AP., Vence, N., et al.[2021]

This study is a randomized controlled trial involving 200 pregnant women with gestational diabetes, aiming to assess the impact of the eMOM GDM mobile app on glucose levels and other maternal and neonatal outcomes.

The intervention group will use the app alongside standard care, tracking glucose and activity, with the primary outcome being the change in fasting plasma glucose from baseline to gestational weeks 35-37, which could provide insights into effective management of GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study). Kytö, M., Markussen, LT., Marttinen, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10664614/

The impact of health coaching on the prevention of gestational ... This study aimed to determine the effect of using health coaching on the prevention of GDM in overweight pregnant women.

2. nature.com nature.com/articles/s43856-024-00491-1

Effective interventions in preventing gestational diabetes ... Physical activity interventions delivered at healthcare facilities reduce the risk of GDM (RR 0.59; 95% CI 0.49, 0.72) compared with home-based ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00102-0/fulltext

a 1-year, prospective, multicentre, randomised controlled trial Primary outcome was achieved by 46.3% (56) of intervention participants compared to 43.3% (52) in the control group [odds ratio (OR) 1.13, 95% ...

4. academic.oup.com academic.oup.com/jcem/article/110/8/e2456/7919651

Effectiveness of a Family-based Health Promotion Intervention ... The Diabetes Prevention Program has shown that a substantial risk reduction is also obtainable among women with prior gestational diabetes mellitus (GDM)—one of ...

5. diabetesjournals.org diabetesjournals.org/care/article/44/2/456/35484/A-Randomized-Controlled-Trial-to-Evaluate-the

A Randomized Controlled Trial to Evaluate the Effects of a ... Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725002554

Step and weight tracking with targets and coaching ... We aimed to assess step and weight changes, with tracking to achieve individualized targets and with coaching conversations on physical activity and eating.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03249896

Web/​Smartphone-based Lifestyle Coaching Program in ... The investigators hypothesize that the use of a web/smartphone-based coaching program specific for the management of GDM can improve clinical outcomes among ...