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临床试验/NCT02422420
NCT02422420已完成不适用

Minnesota Medicaid Incentives to Prevent Chronic Disease

Minnesota Department of Human Services1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,500
试验地点
1
主要终点
DPP Attendance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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.

研究组 & 干预措施

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).

干预措施: Financial Incentives (Behavioral)

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.

干预措施: Financial Incentives (Behavioral)

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.

干预措施: Financial Incentives (Behavioral)

结局指标

主要结局

DPP Attendance

时间窗: 12 months

Participation in DPP core and post-core sessions

Weight Change

时间窗: 12 months

Change in participants' weight

次要结局

未报告次要终点

研究者

发起方
Minnesota Department of Human Services
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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