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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program
Health Mindset modified diabetes prevention program
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Blackfeet Community College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Established Diabetes Prevention Program

Health Mindset modified Diabetes Prevention Program

Arm Description

This arm will receive the established diabetes prevention program curriculum.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

physical activity levels
accelerometer derived measure of average physical activity levels
waist circumference
circumference of the waist will be measured

Full Information

First Posted
September 17, 2020
Last Updated
April 4, 2022
Sponsor
Montana State University
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1. Study Identification

Unique Protocol Identification Number
NCT04571723
Brief Title
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
Official Title
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montana State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be blind to the condition they are in.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Established Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
This arm will receive the established diabetes prevention program curriculum.
Arm Title
Health Mindset modified Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
This arm will receive the modified curriculum with the added health mindset information.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Intervention Description
This is the established Diabetes prevention program curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Health Mindset modified diabetes prevention program
Intervention Description
This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.
Primary Outcome Measure Information:
Title
Change in Health Mindset
Description
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 Outcome Measure Information:
Title
physical activity levels
Description
accelerometer derived measure of average physical activity levels
Time Frame
during the intervention, up to 11 weeks.
Title
waist circumference
Description
circumference of the waist will be measured
Time Frame
baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Blackfeet Community College
City
Browning
State/Province
Montana
ZIP/Postal Code
59417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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