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Behavioural Intervention

Diabetes Prevention Program + INSPIRA for Prediabetes (INSPIRA Trial)

N/A
Waitlist Available
Led By Mary Ellen M Heisler, 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 6 months
Awards & highlights

INSPIRA Trial Summary

This trial is testing how to help people reduce their risk of getting diabetes through a program that includes support and incentives.

Who is the study for?
This trial is for adults with prediabetes, specifically those who have a BMI over 24.9 and an A1c level between 5.7%-6.4%. Participants must be able to attend sessions in English or Spanish and commit to the local area for six months. It's not suitable for individuals with active substance abuse, schizophrenia, or those pregnant or planning pregnancy soon.Check my eligibility
What is being tested?
The study compares two approaches: the standard Diabetes Prevention Program (DPP) versus DPP plus INSPIRA, which includes peer support and healthy food vouchers as incentives. Participants will be randomly assigned to one of these groups for about half a year.See study design
What are the potential side effects?
Since this trial focuses on lifestyle interventions rather than medication, side effects are minimal but may include potential stress from lifestyle changes or disappointment if no immediate health improvements are seen.

INSPIRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weight
Secondary outcome measures
Change in hemoglobin A1c
Change in reported diet quality
Change in waist circumference
+1 more

INSPIRA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DPP plus the INSPIRA interventionExperimental Treatment2 Interventions
This arm will include the DPP plus additional interventions.
Group II: Diabetes Prevention Program (DPP) (usual care)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes Prevention Program
2018
Completed Phase 2
~890

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,916 Total Patients Enrolled
American Diabetes AssociationOTHER
137 Previous Clinical Trials
99,360 Total Patients Enrolled
Mary Ellen M Heisler, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this medical trial?

"This particular trial is no longer searching for participants, with the initial posting date being September 1st 2023 and the last edit occurring on August 14th 2023. Despite this, there are still 232 other medical studies actively recruiting at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Inspiring Action to Prevent Diabetes Intervention
Mary Ellen Michele Heisler 2023. "The Inspiring Action to Prevent Diabetes Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001801.
~95 spots leftby Sep 2026
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