Trial Outcomes & Findings for Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change) (NCT NCT04902326)

Last Updated: 2024-11-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

380 participants

Primary outcome timeframe

baseline to 6 months

Results posted on

2024-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Usual Care (EUC) Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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.
Overall Study STARTED	95	95	95	95
Overall Study 6-month Assessment	85	88	90	88
Overall Study COMPLETED	80	78	81	88
Overall Study NOT COMPLETED	15	17	14	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Usual Care (EUC) Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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.
Overall Study Withdrawal by Subject	1	3	0	1
Overall Study Lost to Follow-up	14	14	14	6

Baseline Characteristics

Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Usual Care (EUC) n=95 Participants Receives one intervention: automated educational text messages Automated educational 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.	Tailored Messages n=95 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Financial Incentives n=95 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=95 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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.	Total n=380 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 9.7 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.3 • n=7 Participants	53.0 years STANDARD_DEVIATION 10.7 • n=5 Participants	54.8 years STANDARD_DEVIATION 8.7 • n=4 Participants	53.7 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	44 Participants n=7 Participants	63 Participants n=5 Participants	61 Participants n=4 Participants	227 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	51 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	153 Participants n=21 Participants
Race/Ethnicity, Customized Race and Ethnicity · Non-Hispanic White	64 Participants n=5 Participants	61 Participants n=7 Participants	65 Participants n=5 Participants	69 Participants n=4 Participants	259 Participants n=21 Participants
Race/Ethnicity, Customized Race and Ethnicity · Non-Hispanic Black	15 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants	50 Participants n=21 Participants
Race/Ethnicity, Customized Race and Ethnicity · HIspanic	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized Race and Ethnicity · Other/ mized Non-Hispanic	13 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	11 Participants n=4 Participants	55 Participants n=21 Participants
Region of Enrollment United States	95 Participants n=5 Participants	95 Participants n=7 Participants	95 Participants n=5 Participants	95 Participants n=4 Participants	380 Participants n=21 Participants
Education 4 years or less of college	58 Participants n=5 Participants	47 Participants n=7 Participants	43 Participants n=5 Participants	54 Participants n=4 Participants	202 Participants n=21 Participants
Education More than 4 years of college	36 Participants n=5 Participants	48 Participants n=7 Participants	52 Participants n=5 Participants	41 Participants n=4 Participants	177 Participants n=21 Participants
Education Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Income Less than $45,000	8 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	28 Participants n=21 Participants
Income Greater than and equal to $45,000	81 Participants n=5 Participants	83 Participants n=7 Participants	82 Participants n=5 Participants	83 Participants n=4 Participants	329 Participants n=21 Participants
Income missing	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Baseline HbA1c	5.9 millimoles per mole (mmol/mol) STANDARD_DEVIATION 0.2 • n=5 Participants	5.9 millimoles per mole (mmol/mol) STANDARD_DEVIATION 0.2 • n=7 Participants	5.9 millimoles per mole (mmol/mol) STANDARD_DEVIATION 0.2 • n=5 Participants	5.9 millimoles per mole (mmol/mol) STANDARD_DEVIATION 0.2 • n=4 Participants	5.9 millimoles per mole (mmol/mol) STANDARD_DEVIATION 0.2 • n=21 Participants
Baseline weight	217.7 pounds STANDARD_DEVIATION 53.2 • n=5 Participants	213.3 pounds STANDARD_DEVIATION 53.2 • n=7 Participants	213.9 pounds STANDARD_DEVIATION 49.8 • n=5 Participants	199.2 pounds STANDARD_DEVIATION 42.3 • n=4 Participants	211.0 pounds STANDARD_DEVIATION 50.1 • n=21 Participants
Baseline autonomous motivation High baseline autonomous motivation	68 Participants n=5 Participants	68 Participants n=7 Participants	68 Participants n=5 Participants	69 Participants n=4 Participants	273 Participants n=21 Participants
Baseline autonomous motivation Low baseline autonomous motivation	27 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	107 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline to 6 months

Population: Data is provided for all individuals who completed an A1c measurement at 6 months. Reported means and confidence intervals are from adjusted models.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care (EUC) n=81 Participants Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives n=87 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages n=89 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=88 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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	-0.05 percentage of hemoglobin A1c Interval -0.14 to 0.03	-0.05 percentage of hemoglobin A1c Interval -0.14 to 0.03	-0.04 percentage of hemoglobin A1c Interval -0.12 to 0.04	-0.04 percentage of hemoglobin A1c Interval -0.13 to 0.04

PRIMARY outcome

Timeframe: baseline to 12 months

Population: In the combo arm, 5 individuals who completed the study did not complete A1c measurement at 12 months. Reported means and confidence intervals are from adjusted models.

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.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care (EUC) n=80 Participants Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives n=78 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages n=81 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=83 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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 12 Months	-0.14 percentage of hemoglobin A1c Interval -0.25 to -0.03	-0.10 percentage of hemoglobin A1c Interval -0.21 to 0.01	-0.12 percentage of hemoglobin A1c Interval -0.22 to 0.0	-0.12 percentage of hemoglobin A1c Interval -0.23 to 0.0

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Data is provided for all individuals who sent in their weight at 6 months. Reported means and confidence intervals are from adjusted models.

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.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care (EUC) n=82 Participants Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives n=80 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages n=85 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=86 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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 Weight From Baseline to 6 Months	-9.63 pounds Interval -15.19 to -4.06	-9.61 pounds Interval -15.15 to -4.07	-11.11 pounds Interval -16.5 to -5.72	-10.63 pounds Interval -16.13 to -5.12

SECONDARY outcome

Timeframe: baseline to 12 months

Population: Data is provided for all individuals who sent in their weight at 12 months. Reported means and confidence intervals are from adjusted models.

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.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care (EUC) n=75 Participants Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives n=72 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages n=76 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=79 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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 Weight From Baseline to 12 Months	-10.20 pounds Interval -17.37 to -3.01	-8.77 pounds Interval -15.9 to -1.64	-10.63 pounds Interval -17.53 to -3.73	-11.02 pounds Interval -18.02 to -4.02

SECONDARY outcome

Timeframe: Months 2-12 of participation in the study

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.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care (EUC) n=95 Participants Receives one intervention: automated educational text messages Automated educational 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.	Financial Incentives n=95 Participants Receives two interventions: automated educational text messages and financial incentives. Automated educational 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. Financial incentives: 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 Messages n=95 Participants Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages. Autonomy-supportive automated educational text messages: 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. Tailored text messages: 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.	Combo Arm-Financial Incentives Plus Tailored Messages Arm n=95 Participants Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives. Autonomy-supportive automated educational text messages: 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 incentives: 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 messages: 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.
Engagement in Diabetes Prevention Program or Use of Metformin	3.6 months Standard Deviation 4.2	6.6 months Standard Deviation 4.5	4.0 months Standard Deviation 4.1	7.2 months Standard Deviation 4.1

Adverse Events

Enhanced Usual Care (EUC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Financial Incentives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Tailored Messages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combo Arm-Financial Incentives Plus Tailored Messages Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Kullgren

University of Michigan Medical School

Phone: 734-845-3613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place