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

Not Applicable

Completed

Conditions: Pre Diabetes

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

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)

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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.
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.
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.