Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
NCT ID: NCT04902326
Last Updated: 2024-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
380 participants
INTERVENTIONAL
2021-09-16
2023-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Responsible Party
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Jeffrey T. Kullgren
Associate Professor of Internal Medicine and Assistant Professor of Health Management and Policy
Principal Investigators
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Jeffrey Kullgren, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Carter 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00188543
Identifier Type: -
Identifier Source: org_study_id