Overweight (BMI > 25)NCT06915194
SMART Pilot Trial of Glycemic Screening Outreach
A study testing Text message, Patient portal message and Mailed letter in people with Overweight (BMI > 25) and Obesity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Overweight (BMI > 25), Obesity
- What is being tested?
- Text message, Patient portal message and Mailed letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 8 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese
Who cannot join
- Existing type 2 diabetes, A1c drawn within past 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.
- Conditions
- Overweight (BMI > 25), Obesity
- Being tested
- Text message, Patient portal message, Mailed letter
- Keywords
- diabetes screening
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messageBehavioural
Participants receive a text message encouraging glycemic screening
Patient portal messageBehavioural
Participants receive a patient portal message encouraging glycemic screening
Mailed letterBehavioural
Participants receive a mailed letter encouraging glycemic screening
| Study group | Role | What they receive |
|---|---|---|
| Initial text, follow-up text, letter | Experimental | Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. Receives: Behavioral: Text message; Behavioral: Mailed letter |
| Initial portal, follow-up portal, letter | Experimental | Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. Receives: Behavioral: Patient portal message; Behavioral: Mailed letter |
| Initial text, follow-up portal, letter | Experimental | Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. Receives: Behavioral: Text message; Behavioral: Patient portal message; Behavioral: Mailed letter |
| Initial portal, follow-up text, letter | Experimental | Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. Receives: Behavioral: Text message; Behavioral: Patient portal message; Behavioral: Mailed letter |
| Usual care | No intervention | Patients do not receive any glycemic screening invitations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Receipt of hemoglobin A1c screening for dysglycemia
Measured: 90 days
Secondary outcomes (1)
Acceptability Survey
The survey contained 5 questions, in Likert response format, and possible total scores ranged from 0 - 24 , with higher scores indicating better satisfaction.
- How did you feel about the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level - Likert responses (Very positive, positive, neutral, negative, very negative)
- How clear were the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level - Likert responses (Very clear, somewhat clear, neutral, somewhat unclear, very unclear)
- Did the messages affect the chances that you would get the hemoglobin A1c (blood sugar) level - Likert responses (Major effect, moderate effect, neutral, minor effect, no effect)
- Did the messages cause you any anxiety or stress - Likert responses (To a great extent, somewhat, very little, not at all)
- How concerned were you that the messages were from scammers not associated with
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start8 Jul 2025
- Primary completion8 Oct 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenrik Duru, University of California, Los Angeles
- Investigators
- Obidiugwu K Duru, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915194
- Sponsor's protocol ID
- IRB-24-6330
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2025
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may or may not attempt to publish this pilot trial
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Pilot Trial of Glycemic Screening Outreach
- ClinicalTrials.gov ID
- NCT06915194
- Acronym / sponsor ID
- IRB-24-6330
- Conditions
- Overweight (BMI > 25), Obesity
- Keywords
- diabetes screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Initial text, follow-up text, letter | Experimental | Behavioral: Text message, Behavioral: Mailed letterParticipants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. |
| Initial portal, follow-up portal, letter | Experimental | Behavioral: Patient portal message, Behavioral: Mailed letterParticipants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. |
| Initial text, follow-up portal, letter | Experimental | Behavioral: Text message, Behavioral: Patient portal message, Behavioral: Mailed letterParticipants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. |
| Initial portal, follow-up text, letter | Experimental | Behavioral: Text message, Behavioral: Patient portal message, Behavioral: Mailed letterParticipants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening. |
| Usual care | No intervention | –Patients do not receive any glycemic screening invitations |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight or obese
Key exclusion criteria (1 listed)
- Existing type 2 diabetes, A1c drawn within past 3 years
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 |
|---|---|---|
| Text messageParticipants receive a text message encouraging glycemic screening | Behavioural | Initial portal, follow-up text, letter, Initial text, follow-up portal, letter, Initial text, follow-up text, letter |
| Patient portal messageParticipants receive a patient portal message encouraging glycemic screening | Behavioural | Initial portal, follow-up portal, letter, Initial portal, follow-up text, letter, Initial text, follow-up portal, letter |
| Mailed letterParticipants receive a mailed letter encouraging glycemic screening | Behavioural | Initial portal, follow-up portal, letter, Initial portal, follow-up text, letter, Initial text, follow-up portal, letter, Initial text, follow-up text, letter |
Primary outcome
Hemoglobin A1c
Time frame: 90 days
Receipt of hemoglobin A1c screening for dysglycemia
1 secondary outcome
Acceptability Survey
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. We may or may not attempt to publish this pilot trial
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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.
Obidiugwu K Duru, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message, Patient portal message and Mailed letter in people with Overweight (BMI > 25) and Obesity, run by University of California, Los Angeles 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 1 inclusion and 1 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 15 May 2026. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.