Prediabetic StateMMIPCDNCT02422420
Minnesota Medicaid Incentives to Prevent Chronic Disease
A study testing Financial Incentives in people with Prediabetic State, run by Minnesota Department of Human Services at 1 site in United States.
Trial summary
The objective of this study is to test whether two different participant financial incentive structures are more effective and cost effective than minimal financial incentives in increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing diabetes. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently enrolled in Medical Assistance, PMAP, or MinnesotaCare (collectively referred to as Medicaid)
- 18-75 years of age
- body mass index ≥ 25 kg/m2 (≥ 22 kg/m2 for those of Asian descent)
- have prediabetes or a history of gestational diabetes mellitus (GDM)
Who cannot join
- diagnosis of diabetes
- pregnant at the time of enrollment
- planning gastric bypass surgery within the next 12 months
- diagnosed with Alzheimer's disease (ICD-9 331.0) or dementia (ICD-9 290.0 - 294.9)
- provider judgment regarding suitability for the study based on substance abuse, uncontrolled mental illness, or other conditions that may affect the participants health or ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Department of Health
Saint Paul, Minnesota, 55164-0882
About this study
The objective of this study is to test whether two different participant financial incentive structures are more effective and cost effective than minimal financial incentives in increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing diabetes. The incentives are tied to participation and weight loss in the evidence-based group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions, (b) demonstrate that prevention of chronic disease risk factors using patient incentives is cost-effective, and (c) provide a patient incentive model that can be widely used among Medicaid beneficiaries at risk for developing diabetes.
- Conditions
- Prediabetic State
- Being tested
- Financial Incentives
- Keywords
- Diabetes Prevention, Financial Incentives, Medicaid, Motivation
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
Use of financial incentives to promote health behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Individual Incentive | Experimental | Participants receive a financial incentive every time they attend a class session and goal-based incentives for attending 75% of Core sessions, 75% of Post-Core sessions, separately achieving 5%, 7%, and 10% weight loss during the Core period (i.e. separate financial incentives for each goal reached at any point during the Core period), and 5%, 7%, or 10% weight loss by the end of Post-Core Session 8 (i.e., one financial incentive based on final weight loss). Receives: Behavioral: Financial Incentives |
| Group Incentive | Experimental | This arm receives the same routine attendance incentives as the Individual Incentive arm. Group goal-based incentives include 5% weight loss by an individual during the Core period and, separately, during the Post-Core period. Financial incentives are also received if the entire DPP group achieves 75% Core session attendance, 75% of Post-Core session attendance, 7% or 10% weight loss from baseline during the Core, and 7% or 10% weight loss from baseline at the end of the Post-Core period. Receives: Behavioral: Financial Incentives |
| Minimal Incentive | Other | Participants receive the full Diabetes Prevention Program (DPP), but receive a nominal $25 financial incentive for attendance only at the first DPP session and no other incentives for attendance or weight loss. Receives: Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPP Attendance
Participation in DPP core and post-core sessions
Measured: 12 months
Weight Change
Change in participants' weight
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionSep 2016
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 Prediabetic StateStudies of the same condition, open and under way.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minnesota Department of Human Services
- Sponsor type
- Other government
- Collaborators
- Minnesota Department of Health, HealthPartners Institute
- Responsible party
- Sponsor
- Investigators
- Gretchen Taylor, Principal investigator, Minnesota Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422420
- Sponsor's protocol ID
- MinnesotaDHS
- Other IDs
- 1B1CMS330877-01-00
- Acronym
- MMIPCD
- Status last verified
- Mar 2016
- First submitted
- 16 Apr 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Desai JR, Vazquez-Benitez G, Taylor G, Johnson S, Anderson J, Garrett JE, Gilmer T, Vue-Her H, Rinn S, Engel K, Schiff J, O'Connor PJ. The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial. BMC Public Health. 2020 Oct 21;20(1):1587. doi: 10.1186/s12889-020-09683-5.
PubMed 33087083
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minnesota Medicaid Incentives to Prevent Chronic Disease
- ClinicalTrials.gov ID
- NCT02422420
- Acronym / sponsor ID
- MMIPCD / MinnesotaDHS
- Conditions
- Prediabetic State
- Keywords
- Diabetes Prevention, Financial Incentives, Medicaid, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Minnesota Department of Human ServicesOther government
- Collaborators
- Minnesota Department of Health, HealthPartners Institute
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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.
The objective of this study is to test whether two different participant financial incentive structures are more effective and cost effective than minimal financial incentives in increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing diabetes. The incentives are tied to participation and weight loss in the evidence-based group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions, (b) demonstrate that prevention of chronic disease risk factors using patient incentives is cost-effective, and (c) provide a patient incentive model that can be widely used among Medicaid beneficiaries at risk for developing diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual Incentive | Experimental | Behavioral: Financial IncentivesParticipants receive a financial incentive every time they attend a class session and goal-based incentives for attending 75% of Core sessions, 75% of Post-Core sessions, separately achieving 5%, 7%, and 10% weight loss during the Core period (i.e. separate financial incentives for each goal reached at any point during the Core period), and 5%, 7%, or 10% weight loss by the end of Post-Core Session 8 (i.e., one financial incentive based on final weight loss). |
| Group Incentive | Experimental | Behavioral: Financial IncentivesThis arm receives the same routine attendance incentives as the Individual Incentive arm. Group goal-based incentives include 5% weight loss by an individual during the Core period and, separately, during the Post-Core period. Financial incentives are also received if the entire DPP group achieves 75% Core session attendance, 75% of Post-Core session attendance, 7% or 10% weight loss from baseline during the Core, and 7% or 10% weight loss from baseline at the end of the Post-Core period. |
| Minimal Incentive | Other | Behavioral: Financial IncentivesParticipants receive the full Diabetes Prevention Program (DPP), but receive a nominal $25 financial incentive for attendance only at the first DPP session and no other incentives for attendance or weight loss. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently enrolled in Medical Assistance, PMAP, or MinnesotaCare (collectively referred to as Medicaid)
- 18-75 years of age
- body mass index ≥ 25 kg/m2 (≥ 22 kg/m2 for those of Asian descent)
- have prediabetes or a history of gestational diabetes mellitus (GDM)
Key exclusion criteria (5 listed)
- diagnosis of diabetes
- pregnant at the time of enrollment
- planning gastric bypass surgery within the next 12 months
- diagnosed with Alzheimer's disease (ICD-9 331.0) or dementia (ICD-9 290.0 - 294.9)
- provider judgment regarding suitability for the study based on substance abuse, uncontrolled mental illness, or other conditions that may affect the participants health or ability to participate in the study.
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 |
|---|---|---|
| Financial IncentivesUse of financial incentives to promote health behaviors. | Behavioural | Group Incentive, Individual Incentive, Minimal Incentive |
Primary outcome
DPP Attendance
Time frame: 12 months
Participation in DPP core and post-core sessions
Weight Change
Time frame: 12 months
Change in participants' weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 33087083Desai JR, Vazquez-Benitez G, Taylor G, Johnson S, Anderson J, Garrett JE, Gilmer T, Vue-Her H, Rinn S, Engel K, Schiff J, O'Connor PJ. The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial. BMC Public Health. 2020 Oct 21;20(1):1587. doi: 10.1186/s12889-020-09683-5.
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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.
Gretchen Taylor principal investigator
Minnesota Department of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives in people with Prediabetic State, run by Minnesota Department of Human Services 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 4 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: finished, as of the sponsor's last update on 18 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DPP Attendance (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02422420, 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 18 Oct 2016.