Status:
COMPLETED
Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pre Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04902326
Start Date
September 16 2021
End Date
September 18 2023
Last Update
November 29 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109