Minnesota Medicaid Incentives to Prevent Chronic Disease

Prediabetic State Clinical Trial

— MMIPCD  

Official title:

Minnesota Medicaid Incentives to Prevent Chronic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422420
• Other study ID #: MinnesotaDHS
• Secondary ID: 1B1CMS330877-01-
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: October 14, 2016
• Start date: March 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Minnesota Department of Human Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Prediabetic State

Intervention

Behavioral:
• Financial Incentives
Use of financial incentives to promote health behaviors.

Locations

Country	Name	City	State
United States	Minnesota Department of Health	St. Paul	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Minnesota Department of Human Services	HealthPartners Institute, Minnesota Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DPP Attendance	Participation in DPP core and post-core sessions	12 months	No
Primary	Weight Change	Change in participants' weight	12 months	No