Clinical trial NCT03283657: Diabetes Risk Education and Communication Trial
Official title: Diabetes Risk Education and Communication Trial (DiRECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Body Weight Changes
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-09-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Assistant Professor
name: Matthew J O'Brien
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.