Pre DiabetesBESTNCT04902326
Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
A study testing Automated educational text messages, Autonomy-supportive automated educational text messages and Financial incentives in people with Pre Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
Patients with prediabetes can significantly reduce their risk of developing type 2 diabetes mellitus (T2DM) by participating in a Diabetes Prevention Program (DPP) or using metformin, but very few patients with prediabetes engage in these strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Automated educational text messages, Autonomy-supportive automated educational text messages and Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 18 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Care Provider part of Michigan Medicine
- Body mass index (BMI) of 25 or higher (23 or higher if of Asian descent)
- Primary health insurance is U-M Premier Care
- Recent Hgb (hemoglobin) A1c 5.7 - 6.4% (inclusive)
Who cannot join
- Participated in pretesting of intervention materials
- Diagnosis of type 2 Diabetes Mellitus
- Serious mental health conditions (described by protocol)
- End stage renal disease (described by protocol)
- Alcohol dependence and opioid dependence (described by protocol)
- Unable to send and receive several text messages weekly
Show all 19Show fewer
- No regular access to a smart phone or tablet with data capabilities or Wireless Fidelity (WiFi) connection at home
- Currently taking metformin
- Unable to take metformin due to contraindications or side effects
- Participated in a Diabetes Prevention Program covered by University of Michigan Premier Care insurance
- Currently enrolled in an interventional research study that is examining how a diet, program, or drug might: promote physical exercise, healthy eating habits, or weight loss; lower blood pressure; or lower blood sugar
- Not planning to live in local area over the next year
- Pregnant or planning a pregnancy in the next year
- Received treatment for an eating disorder (e.g. anorexia or bulimia), not including binge-eating disorder, in last 12 months
- Intensive cancer treatment such as bone marrow transplant, chemotherapy, radiation, or cancer related surgery (not including hormonal chemotherapy like Tamoxifen) in last six months or near future
- Organ transplant in last six months
- Bariatric/ gastric bypass surgery, gastric sleeve surgery, or gastric balloon procedure in last six months
- Stroke, heart attack, heart surgery, or hospitalization for congestive heart failure in the past three months
- Other serious health issues or personal concerns that could prevent participant from completing study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Behavioral Economics and Self-Determination Theory to Advance Patient Engagement in Diabetes Prevention
Patients with prediabetes can significantly reduce their risk of developing type 2 diabetes mellitus (T2DM) by participating in a Diabetes Prevention Program (DPP) or using metformin, but very few patients with prediabetes engage in these strategies. This randomized controlled trial will compare, among adults with prediabetes, the effectiveness of financial incentives, tailored messages based on self-determination theory (SDT) principles, and the combination of financial incentives plus tailored messages based on SDT principles in decreasing hemoglobin A1c (HbA1c) and weight and in increasing participation in a DPP or use of metformin. Our main hypotheses are that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives generic health education messages, and that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives financial incentives alone and the arm that receives tailored messages alone. The study will also identify moderators and mediators of the effectiveness of the interventions and evaluate facilitators of and barriers to scalability, acceptability, and sustainability of the different interventions.
- Conditions
- Pre Diabetes
- Being tested
- Automated educational text messages, Autonomy-supportive automated educational text messages, Financial incentives, Tailored text messages
- Keywords
- Prevention
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated educational text messagesBehavioural
During the first two weeks, participants receive a series of educational messages delivered via text message. These messages welcome participants to the study, set expectations for the next 12 months, and establish a general level of knowledge among all participants on prediabetes, the Diabetes Prevention Program (DPP), and metformin.
For the next 11.5 months, participants receive three automated text messages per week that provide evidence-based educational content about prediabetes and tips on prevention. Additionally, participants receive monthly messages reminding them about their health insurance plan's coverage of the DPP at no cost and coverage of metformin as a low co-pay medication, and monthly messages providing feedback on their participation in the DPP and use of metformin in the previous calendar month. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months.
Autonomy-supportive automated educational text messagesBehavioural
Participants receive the same text messages as in the automated educational text message intervention, but the thrice weekly messages have been modified, where applicable, to support the participant's autonomy, in accordance with principles of Self-Determination Theory. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months.
Financial incentivesBehavioural
Participants in this arm have the opportunity to earn a financial incentive ranging from $50 to $250 per month for taking an evidence-based action to prevent T2DM (i.e., engagement in a DPP or fill of a metformin prescription) in the previous month.
Tailored text messagesBehavioural
Participants receive twice-weekly tailored text messages that link evidence-based actions to prevent T2DM to the participant's self-identified top values, roles, and strengths. Text messages are also tailored, when possible, to participants' self-reported importance of taking action to try to prevent T2DM (i.e., participating in the DPP or taking metformin), confidence in being able to take such preventive action, and past preventive actions taken.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Receives one intervention: automated educational text messages Receives: Behavioral: Automated educational text messages |
| Financial Incentives | Experimental | Receives two interventions: automated educational text messages and financial incentives. Receives: Behavioral: Automated educational text messages; Behavioral: Financial incentives |
| Tailored Messages | Experimental | Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Receives: Behavioral: Autonomy-supportive automated educational text messages; Behavioral: Tailored text messages |
| Combo Arm-Financial Incentives Plus Tailored Messages Arm | Experimental | Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Receives: Behavioral: Autonomy-supportive automated educational text messages; Behavioral: Financial incentives; Behavioral: Tailored text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c From Baseline to 6 Months
Hemoglobin A1C will be tested at a clinical lab using blood samples from venipuncture. An A1C test measures the percentage of red blood cells with glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages. Changes in HbA1c will be calculated by subtracting the baseline value from the 6-month value, with a negative value indicating an HbA1c reduction.
Measured: baseline to 6 months
Change in Hemoglobin A1c From Baseline to 12 Months
Hemoglobin A1C will be tested at a clinical lab using blood samples from venipuncture. An A1C test measures the percentage of red blood cells with glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages. Changes in HbA1c will be calculated by subtracting the baseline value from the 12-month value, with a negative value indicating an HbA1c reduction.
Measured: baseline to 12 months
Secondary outcomes (3)
Change in Weight From Baseline to 6 Months
Participants will measure their body weight (in pounds) using a scale shipped to them by the study. Participants will submit a photo of the weight displayed on the scale. Change in weight will be calculated by subtracting the baseline value from the 6-month value, with a negative value indicating a weight reduction.
Measured: baseline to 6 months
Change in Weight From Baseline to 12 Months
Participants will measure their body weight (in pounds) using a scale shipped to them by the study. Participants will submit a photo of the weight displayed on the scale. Change in weight will be calculated by subtracting the baseline value from the 12-month value, with a negative value indicating a weight reduction.
Measured: baseline to 12 months
Engagement in Diabetes Prevention Program or Use of Metformin
Monthly activity of participants enrolled in an online Diabetes Prevention Program (DPP) will be obtained from the program provider. Prescription fills of metformin will be collected from pharmacy benefits data, and proportion days covered (PDC) will be calculated for each month. For months 2-12 a participant is in the study, they will be considered engaged if the calculated metformin PDC for that month was 80% or higher or if they reached the monthly threshold for DPP engagement (4 lessons completed plus at least two of following for at least 4 days: tracked food intake, weighed themselves, and tracked physical activity). Total number of months engaged will be calculated for each participant. Engagement is not assessed in the first month of the study to allow for time to commence engagement.
Measured: Months 2-12 of participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start16 Sep 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey T. Kullgren, University of Michigan
- Investigators
- Jeffrey Kullgren, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902326
- Sponsor's protocol ID
- HUM00188543
- Other IDs
- 1R18DK122418-01
- Acronym
- BEST
- Status last verified
- Nov 2024
- First submitted
- 21 May 2021
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data will be made available after conclusion of the study upon written request to the study team and approval of the Principal Investigator.
Publications
Kullgren JT, Stoll S, Carter EW, Vadari HS, Resnicow K, Herman WH, Kim HM, McEwen LN, Volpp KG, Heisler M. Motivating Patients to Engage in Evidence-Based Strategies to Prevent Diabetes: A Randomized Controlled Trial. Am J Prev Med. 2026 May 8:108407. doi: 10.1016/j.amepre.2026.108407. Online ahead of print.
PubMed 42107480Carter EW, Vadari HS, Stoll S, Rogers B, Resnicow K, Heisler M, Herman WH, Kim HM, McEwen LN, Volpp KG, Kullgren JT. Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change). Contemp Clin Trials. 2023 Jan;124:107038. doi: 10.1016/j.cct.2022.107038. Epub 2022 Nov 30.
PubMed 36460265
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Behavioral Economics and Self-Determination Theory to Advance Patient Engagement in Diabetes Prevention
- ClinicalTrials.gov ID
- NCT04902326
- Acronym / sponsor ID
- BEST / HUM00188543
- Conditions
- Pre Diabetes
- Keywords
- Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with prediabetes can significantly reduce their risk of developing type 2 diabetes mellitus (T2DM) by participating in a Diabetes Prevention Program (DPP) or using metformin, but very few patients with prediabetes engage in these strategies. This randomized controlled trial will compare, among adults with prediabetes, the effectiveness of financial incentives, tailored messages based on self-determination theory (SDT) principles, and the combination of financial incentives plus tailored messages based on SDT principles in decreasing hemoglobin A1c (HbA1c) and weight and in increasing participation in a DPP or use of metformin. Our main hypotheses are that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives generic health education messages, and that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives financial incentives alone and the arm that receives tailored messages alone. The study will also identify moderators and mediators of the effectiveness of the interventions and evaluate facilitators of and barriers to scalability, acceptability, and sustainability of the different interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Automated educational text messagesReceives one intervention: automated educational text messages |
| Financial Incentives | Experimental | Behavioral: Automated educational text messages, Behavioral: Financial incentivesReceives two interventions: automated educational text messages and financial incentives. |
| Tailored Messages | Experimental | Behavioral: Autonomy-supportive automated educational text messages, Behavioral: Tailored text messagesReceives two interventions: autonomy-supportive automated educational text messages and tailored text messages. |
| Combo Arm-Financial Incentives Plus Tailored Messages Arm | Experimental | Behavioral: Autonomy-supportive automated educational text messages, Behavioral: Financial incentives, Behavioral: Tailored text messagesReceives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Care Provider part of Michigan Medicine
- Body mass index (BMI) of 25 or higher (23 or higher if of Asian descent)
- Primary health insurance is U-M Premier Care
- Recent Hgb (hemoglobin) A1c 5.7 - 6.4% (inclusive)
Key exclusion criteria (19 listed)
- Participated in pretesting of intervention materials
- Diagnosis of type 2 Diabetes Mellitus
- Serious mental health conditions (described by protocol)
- End stage renal disease (described by protocol)
- Alcohol dependence and opioid dependence (described by protocol)
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 |
|---|---|---|
| Automated educational text messagesDuring the first two weeks, participants receive a series of educational messages delivered via text message. These messages welcome participants to the study, set expectations for the next 12 months, and establish a general level of knowledge among all participants on prediabetes, the Diabetes Prevention Program (DPP), and metformin. For the next 11.5 months, participants receive three automated text messages per week that provide evidence-based educational content about prediabetes and tips on prevention. Additionally, participants receive monthly messages reminding them about their health insurance plan's coverage of the DPP at no cost and coverage of metformin as a low co-pay medication, and monthly messages providing feedback on their participation in the DPP and use of metformin in the previous calendar month. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months. | Behavioural | Enhanced Usual Care (EUC), Financial Incentives |
| Autonomy-supportive automated educational text messagesParticipants receive the same text messages as in the automated educational text message intervention, but the thrice weekly messages have been modified, where applicable, to support the participant's autonomy, in accordance with principles of Self-Determination Theory. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months. | Behavioural | Combo Arm-Financial Incentives Plus Tailored Messages Arm, Tailored Messages |
| Financial incentivesParticipants in this arm have the opportunity to earn a financial incentive ranging from $50 to $250 per month for taking an evidence-based action to prevent T2DM (i.e., engagement in a DPP or fill of a metformin prescription) in the previous month. | Behavioural | Combo Arm-Financial Incentives Plus Tailored Messages Arm, Financial Incentives |
| Tailored text messagesParticipants receive twice-weekly tailored text messages that link evidence-based actions to prevent T2DM to the participant's self-identified top values, roles, and strengths. Text messages are also tailored, when possible, to participants' self-reported importance of taking action to try to prevent T2DM (i.e., participating in the DPP or taking metformin), confidence in being able to take such preventive action, and past preventive actions taken. | Behavioural | Combo Arm-Financial Incentives Plus Tailored Messages Arm, Tailored Messages |
Primary outcome
Change in Hemoglobin A1c From Baseline to 6 Months
Time frame: baseline to 6 months
Hemoglobin A1C will be tested at a clinical lab using blood samples from venipuncture. An A1C test measures the percentage of red blood cells with glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages. Changes in HbA1c will be calculated by subtracting the baseline value from the 6-month value, with a negative value indicating an HbA1c reduction.
Change in Hemoglobin A1c From Baseline to 12 Months
Time frame: baseline to 12 months
Hemoglobin A1C will be tested at a clinical lab using blood samples from venipuncture. An A1C test measures the percentage of red blood cells with glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages. Changes in HbA1c will be calculated by subtracting the baseline value from the 12-month value, with a negative value indicating an HbA1c reduction.
3 secondary outcomes
Change in Weight From Baseline to 6 Months
Time frame: baseline to 6 months
Change in Weight From Baseline to 12 Months
Time frame: baseline to 12 months
Engagement in Diabetes Prevention Program or Use of Metformin
Time frame: Months 2-12 of participation in the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42107480Kullgren JT, Stoll S, Carter EW, Vadari HS, Resnicow K, Herman WH, Kim HM, McEwen LN, Volpp KG, Heisler M. Motivating Patients to Engage in Evidence-Based Strategies to Prevent Diabetes: A Randomized Controlled Trial. Am J Prev Med. 2026 May 8:108407. doi: 10.1016/j.amepre.2026.108407. Online ahead of print.
- Derived from this study: PubMed 36460265Carter EW, Vadari HS, Stoll S, Rogers B, Resnicow K, Heisler M, Herman WH, Kim HM, McEwen LN, Volpp KG, Kullgren JT. Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change). Contemp Clin Trials. 2023 Jan;124:107038. doi: 10.1016/j.cct.2022.107038. Epub 2022 Nov 30.
- Individual participant dataSharing planned: Yes. The de-identified data will be made available after conclusion of the study upon written request to the study team and approval of the Principal Investigator.
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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.
Jeffrey Kullgren, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated educational text messages, Autonomy-supportive automated educational text messages and Financial incentives in people with Pre Diabetes, run by University of Michigan 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 4 inclusion and 19 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 29 Nov 2024. 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 29 Nov 2024). 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?
Change in Hemoglobin A1c From Baseline to 6 Months (time frame: baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT04902326, which also lists 2 linked publications.
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 29 Nov 2024.