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Completed

NCT Number: NCT04571723

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blackfeet Community College

Browning, Montana, 59417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Prevention Program

Behavioral

This is the established Diabetes prevention program curriculum.

Health Mindset modified diabetes prevention program

Behavioral

This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.

Primary outcomes

  1. Change in Health Mindset

    Time frame: 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).

Secondary outcomes

  1. physical activity levels

    Time frame: during the intervention, up to 11 weeks.

    accelerometer derived measure of average physical activity levels

  2. waist circumference

    Time frame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)

    circumference of the waist will be measured

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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