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临床试验/NCT04571723
NCT04571723已完成不适用

Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community

Montana State University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in Health Mindset

研究概览

简要总结

The overall goal of this project is to understand whether the established Diabetes prevention program works to reduce diabetes risk by shifting mindsets about health.

详细描述

The Diabetes Prevention Program (DPP), a lifestyle intervention which aims to modify health behaviors, has reduced diabetes risk across several American Indian Communities. However, there were significant attrition rates, and non-completers were at the highest risk at baseline. One's mindset about health (i.e. whether it is fixed or malleable) may affect their likelihood of completing the intervention and its efficacy in reducing risk. With an existing CAB, I will develop a culturally congruent adaptation of the DPP, the Mindset-DPP (M-DPP). The M-DPP will include a discussion of mindset in each session and will present material focused on the plasticity of health, including evidence that one's mindset can affect outcomes that relate to risk for diabetes. The investigators will implement the DPP and the MDPP in a sample of 40 Blackfeet community members at risk for diabetes and test whether the M-DPP associates with greater shifts towards a growth health mindsets (i.e. health can be changed by effort) compared to the DPP, and whether the M-DPP associates with greater increases in physical activity levels and greater reductions in waist circumference, and greater retention compared to the standard DPP.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be blind to the condition they are in.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • self identified as American Indian
  • identified as high risk for diabetes based on the American Diabetes Association paper and pencil test
  • must reside on the Blackfeet reservation

排除标准

  • chronic disease diagnosis

结局指标

主要结局

Change in Health Mindset

时间窗: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)

The Health Mindset Questionnaire will be used to measure the degree to which participants view health as fixed or modifiable. Higher scores on the scale reflect a stronger growth health mindset (i.e. health can be changed) while lower numbers reflect a more fixed health mindset (i.e. health is not modifiable). The range of possible scores is 3-18. Change will be calculated from subtracting the health mindset score will be calculated by subtracting the health mindset score at baseline from subsequent health mindset scores (2 change scores will be calculated: one at 6 weeks after baseline and one at 11 weeks after baseline).

次要结局

  • physical activity levels(during the intervention, up to 11 weeks.)
  • waist circumference(baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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