Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Oct 2021
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedApril 5, 2022
September 1, 2020
4 months
September 17, 2020
April 4, 2022
Conditions
Outcome Measures
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).
baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Secondary Outcomes (2)
physical activity levels
during the intervention, up to 11 weeks.
waist circumference
baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Study Arms (2)
Established Diabetes Prevention Program
ACTIVE COMPARATORThis arm will receive the established diabetes prevention program curriculum.
Health Mindset modified Diabetes Prevention Program
ACTIVE COMPARATORThis arm will receive the modified curriculum with the added health mindset information.
Interventions
This is the established Diabetes prevention program curriculum.
This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- chronic disease diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blackfeet Community College
Browning, Montana, 59417, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will be blind to the condition they are in.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
October 1, 2020
Study Start
October 1, 2021
Primary Completion
January 30, 2022
Study Completion
March 30, 2022
Last Updated
April 5, 2022
Record last verified: 2020-09