- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422420
Minnesota Medicaid Incentives to Prevent Chronic Disease (MMIPCD)
October 14, 2016 updated by: Minnesota Department of Human Services
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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St. Paul, Minnesota, United States, 55164-0882
- Minnesota Department of Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual Incentive
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).
|
Use of financial incentives to promote health behaviors.
|
|
Experimental: Group Incentive
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.
|
Use of financial incentives to promote health behaviors.
|
|
Other: Minimal Incentive
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.
|
Use of financial incentives to promote health behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DPP Attendance
Time Frame: 12 months
|
Participation in DPP core and post-core sessions
|
12 months
|
|
Weight Change
Time Frame: 12 months
|
Change in participants' weight
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gretchen Taylor, Minnesota Department of Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 16, 2015
First Submitted That Met QC Criteria
April 20, 2015
First Posted (Estimate)
April 21, 2015
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 14, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MinnesotaDHS
- 1B1CMS330877-01-00 (Other Identifier: Centers for Medicare and Medicaid Services)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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