Diabetes Risk Education and Communication Trial (DiRECT)

Northwestern University

Status: Completed

Conditions: Diabetes Mellitus; Body Weight; Diabetes Mellitus, Type 2; Body Weight Changes; PreDiabetes

Treatments: Behavioral: DiRECT; Behavioral: Usual care (UC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03283657

STU00204220

R34DK113541 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overweight or obesity
• documentation of prediabetes in medical chart or
• A1c 5.7-6.4

Exclusion criteria

• Age < 18; individuals who are not yet adults (infants, children, teenagers)
• Patient's primary care physician did not provide permission to participate in the study
• Pregnancy status: current or planned pregnancy during study period
• Serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
• Patients that are blind, deaf, or otherwise unable to review study materials
• Prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication
• Diagnosis of post-surgical hypoinsulinemia
• Diagnosis of dementia
• Uncontrolled hypertension (≥160/100 mm Hg)
• No office visit in past 12 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

DiRECT

Experimental group

Description:

DiRECT consists of the following components that will be delivered by medical assistants before patients' routinely scheduled office visits: 1) a prediabetes decision aid focused on type 2 diabetes (T2D) risk and treatment options for preventing T2D; 2) a 'think aloud' exercise; and 3) formulating a preliminary treatment plan for T2D prevention.

Treatment:

Behavioral: DiRECT

Usual Care (UC)

Active Comparator group

Description:

Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.

Treatment:

Behavioral: Usual care (UC)