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NCT04902326 · ClinicalTrials.gov registry record · NA
Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 380
- Enrollment target
NCT04902326: Completed NA study, sponsored by University of Michigan.
NCT04902326 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 380 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04902326, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 380 participants
- Enrollment target
Study 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.
Primary Outcome
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 base
Interventions
- BEHAVIORAL Financial incentives
- BEHAVIORAL Automated educational text messages
- BEHAVIORAL Autonomy-supportive automated educational text messages
- BEHAVIORAL Tailored text messages
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2023-09-18 |
| Phase | NA |
What the finished NCT04902326 record still lists
NCT04902326 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Financial incentives is the first listed.
NCT04902326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04902326 about?
NCT04902326 is a clinical study titled "Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)". 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, am...
What is the current status of trial NCT04902326?
This trial is currently completed. It is a NA study. The enrollment target is 380 participants. The study started on 2021-09-16. Estimated completion is 2023-09-18.
What interventions are being tested in trial NCT04902326?
The interventions under investigation include: Financial incentives (BEHAVIORAL), Automated educational text messages (BEHAVIORAL), Autonomy-supportive automated educational text messages (BEHAVIORAL), Tailored text messages (BEHAVIORAL).
Who is sponsoring clinical trial NCT04902326?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04902326's enrollment target sits among peer trials
380 273rd of 2000 higher than 1,727 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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