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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diabetes Prevention in Prediabetic Patients

NCT01659697

Ethnic Group Young Adults Prediabetes +1 more

UNKNOWN

Obesity and Diabetes Prevention Through Science Enrichment

NCT00541879

Type 2 Diabetes Obesity

COMPLETED NA

Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts

NCT01236794

Diabetes Mellitus, Type 2

COMPLETED NA

Improving Health Habits in Impoverished Populations

NCT00569595

Diabetes Chronic Diseases

COMPLETED PHASE3

Encourage Healthy Families

NCT01823367

Gestational Diabetes Mellitus Pre-diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will be blind to the condition they are in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Established Diabetes Prevention Program

This arm will receive the established diabetes prevention program curriculum.

Group Type ACTIVE_COMPARATOR

Diabetes Prevention Program

Intervention Type BEHAVIORAL

This is the established Diabetes prevention program curriculum.

Health Mindset modified Diabetes Prevention Program

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

Group Type ACTIVE_COMPARATOR

Health Mindset modified diabetes prevention program

Intervention Type BEHAVIORAL

This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diabetes Prevention Program

This is the established Diabetes prevention program curriculum.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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