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Financial incentives for Prediabetes (BEST Trial)
N/A
Waitlist Available
Led By Jeffrey Kullgren, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
BEST Trial Summary
This trial will compare the effectiveness of financial incentives, tailored messages, and a combination of both in decreasing HbA1c and weight and in increasing participation in a DPP or use of metformin among adults with prediabetes.
Eligible Conditions
- Prediabetes
BEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hemoglobin A1C from baseline to 12 months
Change in hemoglobin A1C from baseline to 6 months
Secondary outcome measures
Change in weight from baseline to 12 months
Change in weight from baseline to 6 months
Engagement in DPP
+1 moreBEST Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Tailored MessagesExperimental Treatment2 Interventions
Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.
Group II: Financial IncentivesExperimental Treatment2 Interventions
Receives two interventions: automated educational text messages and financial incentives.
Group III: Combo Arm-Financial Incentives Plus Tailored Messages ArmExperimental Treatment3 Interventions
Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Group IV: Enhanced Usual Care (EUC)Active Control1 Intervention
Receives one intervention: automated educational text messages
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autonomy-supportive automated educational text messages
2021
N/A
~380
Automated educational text messages
2021
N/A
~380
Tailored text messages
2021
N/A
~380
Financial incentives
2018
Completed Phase 3
~26020
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,799 Previous Clinical Trials
6,378,258 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,360 Previous Clinical Trials
4,314,472 Total Patients Enrolled
Jeffrey Kullgren, MDPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe mental health conditions that are specified in the study protocol.You are currently using metformin.You have a severe type of kidney disease known as end-stage renal disease.You had a stroke, heart attack, congestive heart failure, or heart surgery in the last three months.You have any serious health problems or personal issues that may make it difficult for you to finish the study.You cannot send and receive multiple text messages every week.You have a problem with alcohol or opioid addiction.You are overweight, with a BMI of 25 or higher (23 or higher if you are of Asian descent).You cannot take metformin due to medical reasons or experiencing negative side effects.You received treatment for an eating disorder (not including binge-eating disorder) within the last year.You had an organ transplant within the past six months.You are currently participating in a study that involves a diet, exercise, or medication program to improve your physical health or control your blood pressure or sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care (EUC)
- Group 2: Financial Incentives
- Group 3: Tailored Messages
- Group 4: Combo Arm-Financial Incentives Plus Tailored Messages Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the overarching aim of this clinical trial?
"This clinical trial has two primary endpoints, Change in hemoglobin A1C from baseline to 12 months and Change in weight from baseline to 6 months. Participants will assess their bodyweight using a scale at home. Secondary objectives encompass engagement with the DPP program as indicated by health insurance claims, alongside Proportion of days covered by Metformin which is captured via prescription plan claims."
Answered by AI
Does the clinical trial currently accept new participants?
"Per the details available on clinicaltrials.gov, this medical trial is not presently accepting volunteers. It was first launched on September 16th 2021 and edited most recently on October 25th 2022, yet there are a plethora of other trials that remain actively recruiting at present with 1299 in total seeking participants."
Answered by AI
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