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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571723
• Other study ID #: 18-13
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2020
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes Prevention Program
This is the established Diabetes prevention program curriculum.
• Health Mindset modified diabetes prevention program
This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.

Locations

Country	Name	City	State
United States	Blackfeet Community College	Browning	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	physical activity levels	accelerometer derived measure of average physical activity levels	during the intervention, up to 11 weeks.
Secondary	waist circumference	circumference of the waist will be measured	baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)