An interventional study of Automated educational text messages and Autonomy-supportive automated educational text messages in Pre Diabetes, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by University of Michigan · Not applicable, Interventional, and 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.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 380 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receives one intervention: automated educational text messages
Behavioral: Automated educational text messages
Receives two interventions: automated educational text messages and financial incentives.
Behavioral: Automated educational text messages · Behavioral: Financial incentives
Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.
Behavioral: Autonomy-supportive automated educational text messages · Behavioral: Tailored text messages
Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Behavioral: Autonomy-supportive automated educational text messages · Behavioral: Financial incentives · Behavioral: Tailored text messages
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: baseline to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Months 2-12 of participation in the study
| Milestone | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Started | 95 | 95 | 95 | 95 |
| 6-month assessment | 85 | 88 | 90 | 88 |
| Completed | 80 | 78 | 81 | 88 |
| Not completed | 15 | 17 | 14 | 7 |
| Withdrew: Withdrawal by subject | 1 | 3 | 0 | 1 |
| Withdrew: Lost to follow-up | 14 | 14 | 14 | 6 |
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.
| percentage of hemoglobin A1c | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Change in Hemoglobin A1c From Baseline to 6 Months | -0.05 (-0.14 to 0.03) | -0.05 (-0.14 to 0.03) | -0.04 (-0.12 to 0.04) | -0.04 (-0.13 to 0.04) |
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.
| percentage of hemoglobin A1c | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Change in Hemoglobin A1c From Baseline to 12 Months | -0.14 (-0.25 to -0.03) | -0.10 (-0.21 to 0.01) | -0.12 (-0.22 to 0.00) | -0.12 (-0.23 to 0.00) |
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.
| pounds | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Change in Weight From Baseline to 6 Months | -9.63 (-15.19 to -4.06) | -9.61 (-15.15 to -4.07) | -11.11 (-16.50 to -5.72) | -10.63 (-16.13 to -5.12) |
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.
| pounds | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Change in Weight From Baseline to 12 Months | -10.20 (-17.37 to -3.01) | -8.77 (-15.90 to -1.64) | -10.63 (-17.53 to -3.73) | -11.02 (-18.02 to -4.02) |
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.
| months | Enhanced Usual Care (EUC) | Financial Incentives | Tailored Messages | Combo Arm-Financial Incentives Plus Tailored Messages Arm |
|---|---|---|---|---|
| Engagement in Diabetes Prevention Program or Use of Metformin | 3.6 ± 4.2 | 6.6 ± 4.5 | 4.0 ± 4.1 | 7.2 ± 4.1 |
Collected over 12 months for each participant, from randomization to end of study participation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Usual Care (EUC) | 0/95 (0%) | — | — |
| Financial Incentives | 1/95 (1.1%) | — | — |
| Tailored Messages | 0/95 (0%) | — | — |
| Combo Arm-Financial Incentives Plus Tailored Messages Arm | 0/95 (0%) | — | — |
| Age, Continuous(years) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Mean | 52.8 ± 9.7 | 54.2 ± 9.3 | 53.0 ± 10.7 | 54.8 ± 8.7 | 53.7 ± 9.6 |
| Sex: Female, Male(Participants) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Female | 59 | 44 | 63 | 61 | 227 |
| Male | 36 | 51 | 32 | 34 | 153 |
| Race/Ethnicity, Customized(Participants) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Race and Ethnicity — Non-Hispanic White | 64 | 61 | 65 | 69 | 259 |
| Race and Ethnicity — Non-Hispanic Black | 15 | 13 | 9 | 13 | 50 |
| Race and Ethnicity — HIspanic | 3 | 5 | 6 | 2 | 16 |
| Race and Ethnicity — Other/ mized Non-Hispanic | 13 | 16 | 15 | 11 | 55 |
| Region of Enrollment(Participants) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| United States | 95 | 95 | 95 | 95 | 380 |
| Education(Participants) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| 4 years or less of college | 58 | 47 | 43 | 54 | 202 |
| More than 4 years of college | 36 | 48 | 52 | 41 | 177 |
| Missing | 1 | 0 | 0 | 0 | 1 |
| Income(Participants) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Less than $45,000 | 8 | 6 | 8 | 6 | 28 |
| Greater than and equal to $45,000 | 81 | 83 | 82 | 83 | 329 |
| missing | 6 | 6 | 5 | 6 | 23 |
| Baseline HbA1c(millimoles per mole (mmol/mol)) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Mean | 5.9 ± 0.2 | 5.9 ± 0.2 | 5.9 ± 0.2 | 5.9 ± 0.2 | 5.9 ± 0.2 |
| Baseline weight(pounds) | Enhanced Usual Care (EUC) | Tailored Messages | Financial Incentives | Combo Arm-Financial Incentives Plus Tailored Messages Arm | Total |
|---|---|---|---|---|---|
| Mean | 217.7 ± 53.2 | 213.3 ± 53.2 | 213.9 ± 49.8 | 199.2 ± 42.3 | 211.0 ± 50.1 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Icf
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