Digital Health Interventions for Gestational Diabetes

Recruiting at 5 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

227 Participants Needed

What You Need to Know Before You Apply

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.

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.

Is it safe to use digital health interventions for gestational diabetes?

The studies suggest that digital health interventions, like smartphone apps, are generally safe for managing gestational diabetes, as they help track health data and promote healthy lifestyle choices without reported safety concerns. ^{1 2 3 4 5}

How is the treatment 'Digital Health Interventions for Gestational Diabetes' different from other treatments for this condition?

This treatment is unique because it uses digital health tools like an ePlatform, health coach, and resource bank to remotely support and promote healthy lifestyle changes in women with gestational diabetes, unlike traditional in-person methods. ^{1 2 3 6 7}

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. ^{1 3 6 8 9}

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

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Randomised Controlled Trial of a Text Messaging Intervention with Customisation Using Linked Data from Wireless Wearable Activity Monitors to Improve Risk Factors Following Gestational Diabetes. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Women's Usage Behavior and Perceived Usefulness with Using a Mobile Health Application for Gestational Diabetes Mellitus: Mixed-Methods Study. [2021]

3. England 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). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Applying the behaviour change wheel to develop a smartphone application 'stay-active' to increase physical activity in women with gestational diabetes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol: use of a smartphone application to support the implementation of a complex physical activity intervention (+Stay Active) in women with gestational diabetes mellitus-protocol for a non-randomised feasibility study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Technology-supported dietary and lifestyle interventions in healthy pregnant women: a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Use of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education. [2019]