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

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.

Study Overview

• Status: Completed
• Conditions: Pre Diabetes
• Intervention / Treatment: Behavioral: Automated educational text messages; Behavioral: Financial incentives; Behavioral: Autonomy-supportive automated educational text messages; Behavioral: Tailored text messages

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care (EUC); Receives one intervention: automated educational text messages	Behavioral: 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.
Experimental: Financial Incentives; Receives two interventions: automated educational text messages and financial incentives.	Behavioral: 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.; Behavioral: 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.
Experimental: Tailored Messages; Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.	Behavioral: 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.; Behavioral: 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.
Experimental: Combo Arm-Financial Incentives Plus Tailored Messages Arm; Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin A1C from baseline to 6 months	Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.	baseline and 6 months
Change in hemoglobin A1C from baseline to 12 months	Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.	baseline and12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight from baseline to 6 months	Participants will measure their body weight using a scale in their home.	baseline and 6 months
Change in weight from baseline to 12 months	Participants will measure their body weight using a scale in their home.	baseline and 12 months
Engagement in DPP	Health insurance claims will be used to collect this data.	up to 12 months
Proportion of days covered by Metformin	Prescription plan claims will be used to collect this data.	up to 12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jeffrey Kullgren, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Prevention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: HUM00188543; 1R18DK122418-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Once study results are posted on this site (by the primary completion date--no later than 12 months after all primary outcome data have been collected), the de-identified data will be available for five years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No