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

Not Applicable

Completed

• Conditions: Pre Diabetes
• Interventions: Behavioral: Automated educational text messages; Behavioral: Autonomy-supportive automated educational text messages; Behavioral: Financial incentives; Behavioral: Tailored text messages

• Registration Number: NCT04902326
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-26
• Study Start: 2021-09-16
• Primary Completion: 2023-09-18
• Study Completion: 2023-09-18
• Results First Submitted: 2024-09-15
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Results First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Financial Incentives	Automated educational text messages	Receives two interventions: automated educational text messages and financial incentives.
Financial Incentives	Financial incentives	Receives two interventions: automated educational text messages and financial incentives.
Enhanced Usual Care (EUC)	Automated educational text messages	Receives one intervention: automated educational text messages
Combo Arm-Financial Incentives Plus Tailored Messages Arm	Autonomy-supportive automated educational text messages	Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Combo Arm-Financial Incentives Plus Tailored Messages Arm	Financial incentives	Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Combo Arm-Financial Incentives Plus Tailored Messages Arm	Tailored text messages	Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Tailored Messages	Autonomy-supportive automated educational text messages	Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.
Tailored Messages	Tailored text messages	Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c From Baseline to 6 Months	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.
Change in Hemoglobin A1c From Baseline to 12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Weight From Baseline to 6 Months	baseline to 6 months	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.
Change in Weight From Baseline to 12 Months	baseline to 12 months	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.
Engagement in Diabetes Prevention Program or Use of Metformin	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States