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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Diabetes Prevention Program; Behavioral: Health Mindset modified diabetes prevention program

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Browning, Montana, United States, 59417
      • Blackfeet Community College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Established Diabetes Prevention Program; This arm will receive the established diabetes prevention program curriculum.	Behavioral: Diabetes Prevention Program; This is the established Diabetes prevention program curriculum.
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; This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montana State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 18-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No