What this study is
The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:
- Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
- Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.
Participants will:
- Complete surveys at the beginning of the study and up to 2 additional surveys
- If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.
What's being tested
- Risk Informed Shared Decision-Making Strategy (RISE)
Intervention · OTHER
Single visit with health care team member to discuss diabetes risk and choosing next steps
- Low Touch Messaging Strategy (LTM)
Intervention · OTHER
Single message delivered via patient portal system describing diabetes risk and tips to lower risk
Study details
- Official title
- Pilot Trial of a Risk-informed Shared-decision Engagement Strategy
- Sponsor
- Johns Hopkins University
- Conditions
- Prediabetes · Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Enrolling
- 120 people
- Starts
- 2026-08-07
- Est. completion
- 2028-04-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
- Active patient portal account (MyChart)
- Patient receiving primary care at Johns Hopkins Community Physicians in Frederick
- Have overweight or obesity (BMI ≥ 25 kg/m2)
You can't join if
- Have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
- Have dementia
- Previously participated in the Diabetes Prevention Program (DPP)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJohns Hopkins Community Physicians Frederick
Frederick, Maryland, United States
- Study Principal Investigator · Contact410-614-4396preventdiabetes@jhu.edu
- Eva Tseng, MD, MPH · Principal investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00538220
Principal investigator
Eva Tseng, MD, MPH
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.