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
2 other identifiers
interventional
380
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2023
CompletedResults Posted
Study results publicly available
November 29, 2024
CompletedNovember 29, 2024
November 1, 2024
2 years
May 21, 2021
September 15, 2024
November 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
baseline to 12 months
Secondary Outcomes (3)
Change in Weight From Baseline to 6 Months
baseline to 6 months
Change in Weight From Baseline to 12 Months
baseline to 12 months
Engagement in Diabetes Prevention Program or Use of Metformin
Months 2-12 of participation in the study
Study Arms (4)
Enhanced Usual Care (EUC)
ACTIVE COMPARATORReceives one intervention: automated educational text messages
Financial Incentives
EXPERIMENTALReceives two interventions: automated educational text messages and financial incentives.
Tailored Messages
EXPERIMENTALReceives two interventions: autonomy-supportive automated educational text messages and tailored text messages.
Combo Arm-Financial Incentives Plus Tailored Messages Arm
EXPERIMENTALReceives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 36460265DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Kullgren
- Organization
- University of Michigan Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Kullgren, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All investigators, data analysts, and the project manager will be blinded to arm assignment until primary outcome data are collected
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Internal Medicine and Assistant Professor of Health Management and Policy
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 26, 2021
Study Start
September 16, 2021
Primary Completion
September 18, 2023
Study Completion
September 18, 2023
Last Updated
November 29, 2024
Results First Posted
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
- 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.
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.