search
Back to results

Minnesota Medicaid Incentives to Prevent Chronic Disease (MMIPCD)

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Incentives
Sponsored by
Minnesota Department of Human Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Diabetes Prevention, Financial Incentives, Medicaid, Motivation

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minnesota Department of Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Individual Incentive

Group Incentive

Minimal Incentive

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

DPP Attendance
Participation in DPP core and post-core sessions
Weight Change
Change in participants' weight

Secondary Outcome Measures

Full Information

First Posted
April 16, 2015
Last Updated
October 14, 2016
Sponsor
Minnesota Department of Human Services
Collaborators
Minnesota Department of Health, HealthPartners Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02422420
Brief Title
Minnesota Medicaid Incentives to Prevent Chronic Disease
Acronym
MMIPCD
Official Title
Minnesota Medicaid Incentives to Prevent Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota Department of Human Services
Collaborators
Minnesota Department of Health, HealthPartners Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Diabetes Prevention, Financial Incentives, Medicaid, Motivation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual Incentive
Arm Type
Experimental
Arm Description
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).
Arm Title
Group Incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Minimal Incentive
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentives
Intervention Description
Use of financial incentives to promote health behaviors.
Primary Outcome Measure Information:
Title
DPP Attendance
Description
Participation in DPP core and post-core sessions
Time Frame
12 months
Title
Weight Change
Description
Change in participants' weight
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Taylor
Organizational Affiliation
Minnesota Department of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minnesota Department of Health
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55164-0882
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33087083
Citation
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.
Results Reference
derived

Learn more about this trial

Minnesota Medicaid Incentives to Prevent Chronic Disease

We'll reach out to this number within 24 hrs