Behavioral Nudges for Prediabetes
(BEGIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods to help people with prediabetes make lifestyle changes or consider using metformin to prevent diabetes. It focuses on simple interventions, such as decision aids and text messages, to encourage these treatments. Participants will be divided into groups: some will receive both information and text messages, some only one of these, and others will continue with their standard care. It is ideal for adults who are overweight, have prediabetes, and speak either English or Spanish. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing prediabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently using oral corticosteroids, you would not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Decision Aid intervention is safe. Studies indicate it reduces uncertainty and helps people make more confident health choices. Participants reported feeling better about their decisions and were more likely to choose beneficial treatment options.
The Text Messaging intervention also shows positive results. Participants in past studies reported feeling less stressed and better supported. They felt more informed and confident in managing their health. Text messages helped improve their blood sugar control, which is crucial for preventing diabetes.
Using both interventions together has improved health outcomes. These methods provide useful information about diabetes risk and treatment options.
Overall, both interventions have been well-received and have not shown any major safety concerns. They are designed to help people make better health decisions without added risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring innovative ways to combat prediabetes through behavioral nudges. Unlike standard treatments that often focus solely on medication like metformin or lifestyle changes, this trial tests the power of decision aids and text messaging interventions. The decision aid intervention provides personalized information on the benefits and risks of lifestyle changes and medication, aiming to empower patients. Meanwhile, the text messaging intervention delivers biweekly motivational messages, keeping participants engaged and proactive about their health. By combining these approaches, researchers hope to find more effective ways to support lifestyle changes and prevent the progression to diabetes.
What evidence suggests that this trial's interventions could be effective for prediabetes?
Research has shown that tools called decision aids help people make informed choices about preventing diabetes. In this trial, some participants will receive a prediabetes decision aid. Studies have found that this aid leads to a better understanding of the condition, less confusion, and a higher likelihood of starting treatments like lifestyle changes or taking metformin. Other participants will receive text messaging interventions, which previous studies have linked to lower chances of developing diabetes and better blood sugar control. Additionally, one arm of this trial will combine decision aids and text messaging, potentially increasing these benefits and encouraging more people to take steps to prevent diabetes.16789
Who Is on the Research Team?
Matthew J O'Brien, MD
Principal Investigator
Associate Professor
Are You a Good Fit for This Trial?
The BEGIN Trial is for English or Spanish-speaking adults aged 18-80 with prediabetes and overweight (BMI ≥25kg/m2). It's not for those with type 2 diabetes, dementia, current steroid use, pregnancy, no recent doctor visits, kidney issues indicated by high serum creatinine levels, past metformin use or very high blood pressure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive behavioral nudges through decision aids and/or text messaging interventions to promote diabetes prevention over 12 months
Follow-up
Participants are monitored for weight changes and treatment initiation of intensive lifestyle intervention or Metformin
What Are the Treatments Tested in This Trial?
Interventions
- Automated intervention
- Decision Aid intervention
- In-person intervention
- Text Messaging intervention
- Usual Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor