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CompletedNCT04571723Updated Apr 5, 2022

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

An interventional study of Diabetes Prevention Program and Health Mindset modified diabetes prevention program in Diabetes Mellitus, Type 2, sponsored by Montana State University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Montana State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

-chronic disease diagnosis

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Established Diabetes Prevention Program

    This arm will receive the established diabetes prevention program curriculum.

    Behavioral: Diabetes Prevention Program

  • Active comparator
    Health Mindset modified Diabetes Prevention Program

    This arm will receive the modified curriculum with the added health mindset information.

    Behavioral: Health Mindset modified diabetes prevention program

Interventions

  • BehavioralDiabetes Prevention Program

    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.

06

What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. physical activity levels

    accelerometer derived measure of average physical activity levels

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

  2. waist circumference

    circumference of the waist will be measured

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

07

Study locations

1 site
  • Blackfeet Community College
    Browning, Montana 59417, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04571723
Lead sponsor
Montana State University
Responsible party
Sponsor
First posted
Oct 1, 2020
Start date
Oct 1, 2021
Primary completion
Jan 30, 2022
Completion
Mar 30, 2022
Last update
Apr 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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