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NCT Number: NCT03283657

Diabetes Risk Education and Communication Trial

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.

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Key information

Conditions

PreDiabetes Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DiRECT

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)

Behavioral

Standard care with routine medical care.

Primary outcomes

  1. Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin

    Time frame: 3 months

    The number of participants that initiate ILI, Metformin, or both treatments at follow-up is the primary outcome of the pilot trial, which will be assessed in the following ways. Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose. Attendance logs will be used to confirm whether participants attended at least 1 ILI session. Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment. Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment. Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

Diabetes Risk Education and Communication Trial (DiRECT)

Acronym: DiRECT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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