An interventional study of DiRECT and Usual care (UC) in PreDiabetes, Diabetes Mellitus and Diabetes Mellitus, Type 2, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-07.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
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.
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's enrollment of 53 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: DiRECT
Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.
Behavioral: Usual care (UC)
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.
Standard care with routine medical care.
Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
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.
Time frame: 3 months
Plan to share: No
Ran from Nov 2017 to primary completion in Mar 2019, 16 months.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 16 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.