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

Pre Diabetes Clinical Trial

— BEST  

Official title:

Integrating Behavioral Economics and Self-Determination Theory to Advance Patient Engagement in Diabetes Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902326
• Other study ID #: HUM00188543
• Secondary ID: 1R18DK122418-01
• Status: Completed
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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