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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program
* Behavioral: Health Mindset modified diabetes prevention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -chronic disease diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Established Diabetes Prevention Program<br>This arm will receive the established diabetes prevention program curriculum. | Behavioral: Diabetes Prevention Program<br>* This is the established Diabetes prevention program curriculum.<br>|
| Active Comparator: Health Mindset modified Diabetes Prevention Program<br>This arm will receive the modified curriculum with the added health mindset information. | Behavioral: Health Mindset modified diabetes prevention program<br>* This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Mindset | 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). | baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity levels | accelerometer derived measure of average physical activity levels | during the intervention, up to 11 weeks. | 
| waist circumference | circumference of the waist will be measured | baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline) |