NCT03283657

Diabetes Risk Education and Communication Trial

Diabetes Risk Education and Communication Trial (DiRECT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. This pilot study will develop and evaluate the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.

Detailed description

Landmark clinical trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for preventing diabetes among adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used in practice and little existing research has focused on approaches for promoting their use. This novel intervention, delivered by medical assistants before patients' routinely scheduled office visits, consists of the following 3 components intended to promote initiation of ILI and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary treatment plan. Previous studies report that medical assistants can improve uptake of some preventive health services in primary care, which may also be true for ILI and metformin.

Conditions

• PreDiabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Body Weight
• Body Weight Changes

Interventions

Type	Name	Description
BEHAVIORAL	DiRECT	DiRECT participants will meet with a medical assistant (MA) before a routinely scheduled office and formulate a preliminary treatment plan for T2D prevention. Participants will attend their scheduled physician visit, during which they may make a definitive treatment plan to initiate metformin and/or ILI.
BEHAVIORAL	Usual care (UC)	Standard care with routine medical care.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-03-17
• Completion: 2019-03-17
• First posted: 2017-09-14
• Last updated: 2022-03-07

Locations

1 site across 1 country: United States