Diabetes Risk Education and Communication Trial

NCT ID: NCT03283657

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-03-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

DiRECT

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.

Group Type: EXPERIMENTAL

DiRECT

Intervention Type: BEHAVIORAL

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.

Usual Care (UC)

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

Group Type: ACTIVE_COMPARATOR

Usual care (UC)

Intervention Type: BEHAVIORAL

Standard care with routine medical care.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care (UC)

Standard care with routine medical care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Matthew J O'Brien

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J O'Brien

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

O'Brien MJ, Cameron KA, Vargas MC, Mohr L, Williams GC, Fagerlin A, Kandula NR. Evaluation of a Prediabetes Decision Aid on Patient-Reported Outcomes in Primary Care: a Pilot Study. J Gen Intern Med. 2021 Mar;36(3):824-826. doi: 10.1007/s11606-020-05936-6. Epub 2020 Jun 15. No abstract available.

Reference Type: DERIVED

PMID: 32542497 (View on PubMed)

Other Identifiers

R34DK113541

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00204220

Identifier Type: -

Identifier Source: org_study_id