Texting Intervention for Gestational Diabetes

Not currently recruiting at 1 trial location

Overseen By Katherine Mathews, MD, MPH, MBA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: St. Louis University

Disqualifiers: Hospitalization, Fetal malformation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether text message reminders can help pregnant individuals with gestational diabetes adhere to their care plans. Gestational diabetes develops during pregnancy and can cause complications for both mother and baby if not well-managed. Participants will receive text reminders about appointments and medication schedules, while a control group will continue with standard care. This trial suits pregnant individuals with gestational diabetes, a single pregnancy, and access to a cell phone with texting capabilities. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance care for gestational diabetes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this texting intervention is safe for gestational diabetes management?

Research has shown that using text messages to manage health conditions, such as gestational diabetes, is safe. Several studies have explored the role of text messaging in supporting individuals with gestational diabetes. These studies found that participants felt comfortable receiving text messages. For instance, the Text 4 Success study tested a text messaging program for women with gestational diabetes and found it easy to use and well-received. Another study demonstrated that text messages promoting healthy habits increased physical activity among women. No major negative effects were reported in these studies, suggesting that text messaging is a safe method for managing health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support women with gestational diabetes using personalized text message reminders. Unlike standard treatments that primarily focus on medication and dietary changes, this approach leverages technology to enhance patient engagement and adherence. The text messages offer timely reminders for appointments and medication adjustments, as well as postpartum glucose testing, aiming to improve health outcomes by keeping patients on track with their care plan. This method could provide a simple yet effective way to complement traditional treatments and ensure continuous support throughout and after pregnancy.

What evidence suggests that this texting intervention is effective for gestational diabetes?

Research shows that texting can help manage gestational diabetes. In this trial, participants in the "Texting" group will receive personalized text message reminders to support their treatment plans. One study found that sending text messages improved blood sugar control, with a noticeable drop in A1C levels, which measure average blood sugar over a few months. Another study discovered that women who recently had gestational diabetes became more physically active after receiving encouraging text messages, which can help manage the condition. Evidence also suggests that personalized text messages can positively impact weight management and pregnancy outcomes. These findings indicate that text messaging could be a helpful tool in managing gestational diabetes by reminding and motivating patients to follow their treatment plans. ^{1 2 3 5 6}

Who Is on the Research Team?

Dorothea Mostello, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older with either gestational diabetes or pre-existing diabetes and a confirmed viable single pregnancy. They must have access to a cell phone with texting capabilities. Women hospitalized for pregnancy complications or without a cell phone, as well as those carrying babies with malformations, cannot participate.

Inclusion Criteria

The patient has access to a cellular phone with a text messaging plan

I have diabetes and am currently pregnant.

I am a pregnant woman aged 18 or older.

Exclusion Criteria

The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy

The patient does not have a cellular phone

My unborn baby has been diagnosed with a genetic or structural abnormality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diabetes education and are started on an individualized diabetic diet regimen. Text message reminders are sent for appointments and medication adherence.

Up to 9 months

Regular prenatal visits with text reminders

Postpartum Follow-up

Participants receive text message reminders for postpartum glucose tolerance tests at 2, 6, and 10 weeks postpartum.

10 weeks

Postpartum visits with text reminders

Survey Completion

Participants complete surveys to evaluate barriers to healthcare and perspectives on the study.

Ongoing until postpartum visit

What Are the Treatments Tested in This Trial?

Interventions

• Texting

Trial Overview The study is testing whether text message reminders and educational content can help pregnant women with diabetes better adhere to their care regimen. Participants will be randomly assigned to receive these text interventions and their adherence to the recommended care will be monitored.

How Is the Trial Designed?

Group I: Texting Active Control 1 Intervention

Patients in the "Texting" group will receive reminders based on their individual disease treatment. A text message shall be sent one day (12 to 36 hours) before appointments to remind about the appointment and with instructions to bring glucose and food records to the appointment. If medication changes are made at the appointment, the patient will receive a text message reminder the day after her appointment to reinforce the regimen. Postpartum patients who had GDM will receive a text message reminder to complete their glucose tolerance test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10 weeks postpartum if the testing is not completed.

Group II: No texting Active Control 1 Intervention

Patients in the contact control group will be enrolled in the text4baby program with assistance from a healthcare provider. As the study will conclude upon the patient's postpartum visit, she will be offered the option of discontinuing messages, which otherwise would continue through the infant's first year of life.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8905478/

Development and Usability of a Text Messaging Program ... SMS text messaging is an effective way to improve diabetes management outside of pregnancy, but has not been well studied in GDM.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6470941/

A Pilot Randomised Controlled Trial of a Text Messaging ... Overall, results suggest that a text message and activity monitor intervention is feasible for a larger study or even as a potentially scalable population ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822722008051

Text messages promoting healthy lifestyle and linked with ... Women with recent GDM increase their step count in the hours following positive and supportive text messages.

4. bmjopen.bmj.com bmjopen.bmj.com/content/11/9/e054756

Effectiveness of a customised mobile phone text ... Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1555415524000321

The Use of SMS Text Messaging to Improve Glycemic ... Results showed significant improvements in glycemic control (ie, decrease in A1C of 1.04%; P = 0.05). The SMS text messaging intervention effectively supports ...

6. mdpi.com mdpi.com/2072-6643/16/6/820

Randomised Controlled Trial of a Customised Text ... Women with GDM were randomised following delivery to receive four text messages per week supporting a healthy lifestyle and parenting for 6 months, with ...