PreDiabetesDiRECTNCT03283657
Diabetes Risk Education and Communication Trial
A study testing DiRECT in people with PreDiabetes and Diabetes Mellitus, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- DiRECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 17 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obesity
- documentation of prediabetes in medical chart or
- A1c 5.7-6.4
Who cannot join
- 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
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- Diagnosis of post-surgical hypoinsulinemia
- Diagnosis of dementia
- Uncontrolled hypertension (≥160/100 mm Hg)
- No office visit in past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Risk Education and Communication Trial (DiRECT)
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.
Read the 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
- Being tested
- DiRECT, Usual care (UC)
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Diabetes Mellitus, Type 2, Body Weight, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiRECTBehavioural
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)Behavioural
Standard care with routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| DiRECT | Experimental | 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. Receives: Behavioral: DiRECT |
| Usual Care (UC) | Active comparator | Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention. Receives: Behavioral: Usual care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Nov 2017
- Primary completion17 Mar 2019
- Study completion17 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J O'Brien, Northwestern University
- Investigators
- Matthew J O'Brien, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283657
- Sponsor's protocol ID
- STU00204220
- Other IDs
- R34DK113541
- Acronym
- DiRECT
- Status last verified
- Mar 2022
- First submitted
- 22 Aug 2017
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32542497
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Risk Education and Communication Trial (DiRECT)
- ClinicalTrials.gov ID
- NCT03283657
- Acronym / sponsor ID
- DiRECT / STU00204220
- Conditions
- PreDiabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Body Weight, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiRECT | Experimental | Behavioral: DiRECTDiRECT 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. |
| Usual Care (UC) | Active comparator | Behavioral: Usual care (UC)Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obesity
- documentation of prediabetes in medical chart or
- A1c 5.7-6.4
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiRECTDiRECT 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. | Behavioural | DiRECT |
| Usual care (UC)Standard care with routine medical care. | Behavioural | Usual Care (UC) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Derived from this study: PubMed 32542497O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J O'Brien principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiRECT in people with PreDiabetes and Diabetes Mellitus, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.