120 Participants NeededMy employer runs this trial

Shared Decision-Making for Prediabetes

(RISE Trial)

ET
RS
Overseen ByResearch Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if understanding diabetes risk can motivate individuals with prediabetes to take preventive action. It tests two strategies: a meeting with a healthcare team to discuss diabetes risk, known as the Risk Informed Shared Decision-Making Strategy (RISE), and a simple message sent via a patient portal, called the Low Touch Messaging Strategy (LTM). Researchers seek to discover if these methods encourage more steps toward diabetes prevention compared to usual care. Individuals may be a good fit if they have been informed of having prediabetes and have an active patient portal account at Johns Hopkins Community Physicians in Frederick. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for diabetes prevention.

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 seems focused on discussing diabetes risk and prevention steps, so it's best to ask the trial organizers for more details.

What prior data suggests that these strategies are safe for participants?

Research has shown that both the Low Touch Messaging Strategy and the Risk Informed Shared Decision-Making Strategy are generally safe for participants.

For the Low Touch Messaging Strategy, studies have found that text message reminders are well-received. In one study, 84% of participants found the messages helpful and appreciated them as reminders. These messages also improved blood sugar control in people with diabetes.

For the Risk Informed Shared Decision-Making Strategy, research indicates it boosts patient involvement in preventing diabetes. Participants in these programs reported positive results, such as maintaining weight loss over time.

Both strategies emphasize communication and information, involving minimal physical risk. Evidence suggests these methods are safe and can help people make informed health decisions.12345

Why are researchers excited about this trial?

Researchers are excited about these strategies for prediabetes because they offer personalized approaches to risk management. The Risk Informed Shared Decision-Making Strategy (RISE) provides a one-on-one consultation with a healthcare professional to discuss an individual's diabetes risk and personalized prevention strategies, which could lead to more tailored and effective interventions. Meanwhile, the Low Touch Messaging Strategy (LTM) offers an innovative, low-effort way to inform patients of their risk and provide actionable tips through simple messages, making it easier for people to engage with their health without needing frequent clinic visits. These methods aim to enhance patient engagement and proactive health management, potentially leading to better outcomes compared to the usual care, which often lacks this personalized focus.

What evidence suggests that this trial's strategies could be effective for prediabetes?

This trial will compare different strategies for managing prediabetes. Participants in one arm will receive a Low Touch Messaging Strategy, where simple messages sent through the patient portal describe their diabetes risk level and offer tips to lower it. Research has shown that text messaging can help people with prediabetes manage their condition, with studies finding slight improvements in blood sugar levels over a few months. Participants often find these messages helpful reminders to stay focused on their health goals.

In another arm, participants will engage in a Risk-Informed Shared Decision-Making Strategy, involving a visit with a healthcare team member to discuss diabetes risks and prevention. Shared decision-making has shown good results, with research indicating it can lead to more weight loss and greater patient involvement in preventing diabetes. Overall, both methods have evidence supporting their effectiveness in promoting better health outcomes for people with prediabetes.12567

Who Is on the Research Team?

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Eva Tseng, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who are patients at Johns Hopkins Community Physicians in Frederick, have prediabetes (recent blood sugar slightly above normal), a BMI of 25 or higher (overweight/obesity), and use the MyChart patient portal.

Inclusion Criteria

* active patient portal account (MyChart)
* have overweight or obesity (BMI ≥ 25 kg/m2)
* prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a shared-decision making visit or a simple message about diabetes risk

1 visit
1 visit (in-person for shared-decision making group)

Follow-up

Participants are monitored for changes in diabetes risk management and treatment uptake

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low Touch Messaging Strategy (LTM)
  • Risk Informed Shared Decision-Making Strategy (RISE)

Trial Overview

The study compares two ways to help people with prediabetes take steps to prevent diabetes: a one-time shared decision-making visit with a healthcare provider about their risk, and simple messages sent through the patient portal. Both are compared to usual care.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Risk-Informed Shared Decision-Making Engagement StrategyActive Control1 Intervention
Group II: Low Touch Messaging StrategyActive Control1 Intervention
Group III: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+

Citations

Advancing Type 2 Diabetes Prevention through Text ... - PMC

A total of 84% found the text-messages informative, appreciating them as gentle reminders for accountability, though some felt they were overly ...

Effectiveness of Text Messaging Interventions on BMI Among ...

Objective: This study aims to evaluate the effectiveness of text message–delivered lifestyle programs for BMI among adults with prediabetes and, ...

Text messaging interventions are associated with ...

Conclusion Text messaging interventions are associated with modest improvements in glycemic control over 3–6 months, particularly in patients ...

Effectiveness of Smartphone Application‐Based Interventions ...

Our study shows that app‐based interventions can improve outcomes (i.e., motivation, behavior, and clinical parameters) in individuals with prediabetes. The ...

The South African Diabetes Prevention Programme

This paper describes the process of developing text messages targeting behavior change in people at risk of developing diabetes in low-resourced communities.

Leveraging Technology and Theory to Change Health ...

The data confirm that using theoretically driven, interactive, tailored text messaging can increase awareness of prediabetes risk, readiness to ...

Design and Rationale of Behavioral Nudges for Diabetes ...

Findings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care ...