PreDiabetesINSPIRANCT06001801
The Inspiring Action to Prevent Diabetes Intervention
A study testing Diabetes Prevention Program and INSPIRA in people with PreDiabetes, run by University of Michigan at 1 site in United States.
Trial summary
This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Diabetes Prevention Program and INSPIRA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish-speaking
- Body Mass Index (BMI) > 24.9 kilograms/meters squared (kg/m2)
- The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4%
Who cannot join
- Diagnosed with schizophrenia
- Active alcohol or other drug abuse
- Are pregnant or planning pregnancy in next 6 months
- Will not be in local area in six months
- Will not be able to attend sessions, in-person or remotely, for three more weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Health and Social Services Center, Incorporated
Detroit, Michigan, 48209
About this study
Official title: Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention
This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes.
This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers.
Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.
- Conditions
- PreDiabetes
- Being tested
- Diabetes Prevention Program, INSPIRA
- Keywords
- Diabetes Prevention Program, Behaviors, Weight loss, Healthy lifestyle changes, Peer Partner
- Medical subject headings
- Prediabetic State, Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.
This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.
Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.
Participation in this project should last approximately 6-months.
INSPIRABehavioural
This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session.
CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions.
Participation in this project should last approximately 6-months.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Program (DPP) (usual care) | Active comparator | Not described Receives: Behavioral: Diabetes Prevention Program |
| DPP plus the INSPIRA intervention | Experimental | This arm will include the DPP plus additional interventions. Receives: Behavioral: Diabetes Prevention Program; Behavioral: INSPIRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of group sessions attended by participants
This count will be out of 16 possible weekly group sessions.
Measured: 6 months
Secondary outcomes (4)
Change in weight
Weight will be measured in pounds to the nearest tenth.
Measured: baseline, 6 months
Change in hemoglobin A1c
Measured: baseline, 6 months
Change in waist circumference
This will be measured in centimeters.
Measured: baseline, 6 months
Change in reported diet quality
measured by comparing baseline and six month survey responses
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start18 Sep 2023
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Mary Ellen Michele Heisler, University of Michigan
- Investigators
- Mary Ellen M Heisler, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001801
- Sponsor's protocol ID
- HUM00227197
- Acronym
- INSPIRA
- Status last verified
- Nov 2025
- First submitted
- 14 Aug 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heisler M, Quiroga G, Valbuena F, Resnicow K, Stoll S, Griauzde DH, Hofer T, Kullgren JT. INSPIRing Action to Prevent Diabetes (INSPIRA): Rationale and description of a pilot intervention combining peer support and food voucher incentives to increase engagement in a community health worker-led diabetes prevention program. Contemp Clin Trials. 2025 Aug;155:107971. doi: 10.1016/j.cct.2025.107971. Epub 2025 May 31.
PubMed 40456483
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention
- ClinicalTrials.gov ID
- NCT06001801
- Acronym / sponsor ID
- INSPIRA / HUM00227197
- Conditions
- PreDiabetes
- Keywords
- Diabetes Prevention Program, Behaviors, Weight loss, Healthy lifestyle changes, Peer Partner
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes.
This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers.
Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Program (DPP) (usual care) | Active comparator | Behavioral: Diabetes Prevention Program |
| DPP plus the INSPIRA intervention | Experimental | Behavioral: Diabetes Prevention Program, Behavioral: INSPIRAThis arm will include the DPP plus additional interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish-speaking
- Body Mass Index (BMI) > 24.9 kilograms/meters squared (kg/m2)
- The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4%
Key exclusion criteria (5 listed)
- Diagnosed with schizophrenia
- Active alcohol or other drug abuse
- Are pregnant or planning pregnancy in next 6 months
- Will not be in local area in six months
- Will not be able to attend sessions, in-person or remotely, for three more weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Prevention ProgramThe DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs. This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food. Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged. Participation in this project should last approximately 6-months. | Behavioural | DPP plus the INSPIRA intervention, Diabetes Prevention Program (DPP) (usual care) |
| INSPIRAThis intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session. CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions. Participation in this project should last approximately 6-months. | Behavioural | DPP plus the INSPIRA intervention |
Primary outcome
Number of group sessions attended by participants
Time frame: 6 months
This count will be out of 16 possible weekly group sessions.
4 secondary outcomes
Change in weight
Time frame: baseline, 6 months
Change in hemoglobin A1c
Time frame: baseline, 6 months
Change in waist circumference
Time frame: baseline, 6 months
Change in reported diet quality
Time frame: baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 40456483Heisler M, Quiroga G, Valbuena F, Resnicow K, Stoll S, Griauzde DH, Hofer T, Kullgren JT. INSPIRing Action to Prevent Diabetes (INSPIRA): Rationale and description of a pilot intervention combining peer support and food voucher incentives to increase engagement in a community health worker-led diabetes prevention program. Contemp Clin Trials. 2025 Aug;155:107971. doi: 10.1016/j.cct.2025.107971. Epub 2025 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ellen M Heisler, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program and INSPIRA in people with PreDiabetes, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of group sessions attended by participants (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.