Minnesota Medicaid Incentives to Prevent Chronic Disease

NCT ID: NCT02422420

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Prediabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Financial Incentives

Intervention Type: BEHAVIORAL

Use of financial incentives to promote health behaviors.

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.

Group Type: EXPERIMENTAL

Financial Incentives

Intervention Type: BEHAVIORAL

Use of financial incentives to promote health behaviors.

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.

Group Type: OTHER

Financial Incentives

Intervention Type: BEHAVIORAL

Use of financial incentives to promote health behaviors.

Interventions

Financial Incentives

Use of financial incentives to promote health behaviors.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minnesota Department of Health

OTHER_GOV

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: collaborator

Minnesota Department of Human Services

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen Taylor

Role: PRINCIPAL_INVESTIGATOR

Minnesota Department of Health

Locations

Minnesota Department of Health

Saint Paul, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33087083 (View on PubMed)

Other Identifiers

1B1CMS330877-01-00

Identifier Type: OTHER

Identifier Source: secondary_id

MinnesotaDHS

Identifier Type: -

Identifier Source: org_study_id