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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04571723
Enrollment
24
Registered
2020-10-01
Start date
2021-10-01
Completion date
2022-03-30
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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.

Detailed 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.

Interventions

This is the established Diabetes prevention program curriculum.

BEHAVIORALHealth 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.

Sponsors

Montana State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants will be blind to the condition they are in.

Intervention model description

One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Health Mindsetbaseline, 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

MeasureTime frameDescription
physical activity levelsduring the intervention, up to 11 weeks.accelerometer derived measure of average physical activity levels
waist circumferencebaseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)circumference of the waist will be measured

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026