Recruiting

Shared Decision-Making

Sponsor:

Johns Hopkins University

Code:

NCT07553325

Conditions

Prediabetes

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Risk Informed Shared Decision-Making Strategy (RISE)

Low Touch Messaging Strategy (LTM)

Study Details

Brief summary:

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.

Conditions

Prediabetes

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Study ID

NCT07553325

Start date

Aug 7, 2026

Status verified date

Aug, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
  • have dementia
  • previously participated in the Diabetes Prevention Program (DPP)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Risk-Informed Shared Decision-Making Engagement Strategy

Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it.

active comparator: Low Touch Messaging Strategy

Participants receive a simple message in the patient portal describing the participant's level of risk of diabetes and tips on how to lower the risk

no intervention: Usual Care

Participants will continue with usual care at the clinic

Interventions

Risk Informed Shared Decision-Making Strategy (RISE)

Single visit with health care team member to discuss diabetes risk and choosing next steps

Low Touch Messaging Strategy (LTM)

Single message delivered via patient portal system describing diabetes risk and tips to lower risk

Primary outcome measure

  • Presence of a DPP referral or new metformin prescription [ Time Frame: From randomization to 3 months after randomization ]

Central Contacts and Locations

Central contacts

Research Study Coordinator

410-614-4396preventdiabetes@jh.edu

Eva Tseng, MD, MPH

etseng3@jhmi.edu

Locations

Johns Hopkins Community Physicians Frederick

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Study Principal Investigator

410-614-4396preventdiabetes@jhu.edu

Principal Investigator:

Eva Tseng, MD, MPH

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • shared decision-making
  • diabetes risk
  • diabetes prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-28.