Diabetes Mellitus, Type 2NCT04571723
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
A study testing Diabetes Prevention Program and Health Mindset modified diabetes prevention program in people with Diabetes Mellitus, Type 2, run by Montana State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Prevention Program and Health Mindset modified diabetes prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- -chronic disease diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Blackfeet Community College
Browning, Montana, 59417
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Prevention Program, Health Mindset modified diabetes prevention program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
This is the established Diabetes prevention program curriculum.
Health Mindset modified diabetes prevention programBehavioural
This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.
| Study group | Role | What they receive |
|---|---|---|
| Established Diabetes Prevention Program | Active comparator | This arm will receive the established diabetes prevention program curriculum. Receives: Behavioral: Diabetes Prevention Program |
| Health Mindset modified Diabetes Prevention Program | Active comparator | This arm will receive the modified curriculum with the added health mindset information. Receives: Behavioral: Health Mindset modified diabetes prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Secondary outcomes (2)
physical activity levels
accelerometer derived measure of average physical activity levels
Measured: during the intervention, up to 11 weeks.
waist circumference
circumference of the waist will be measured
Measured: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2021
- Primary completion30 Jan 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571723
- Sponsor's protocol ID
- 18-13
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
- ClinicalTrials.gov ID
- NCT04571723
- Acronym / sponsor ID
- 18-13
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
| Arm | Type | Receives |
|---|---|---|
| Established Diabetes Prevention Program | Active comparator | Behavioral: Diabetes Prevention ProgramThis arm will receive the established diabetes prevention program curriculum. |
| Health Mindset modified Diabetes Prevention Program | Active comparator | Behavioral: Health Mindset modified diabetes prevention programThis arm will receive the modified curriculum with the added health mindset information. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -chronic disease diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Prevention ProgramThis is the established Diabetes prevention program curriculum. | Behavioural | Established Diabetes Prevention Program |
| Health Mindset modified diabetes prevention programThis is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health. | Behavioural | Health Mindset modified Diabetes Prevention Program |
Primary outcome
Change in Health Mindset
Time frame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
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).
2 secondary outcomes
physical activity levels
Time frame: during the intervention, up to 11 weeks.
waist circumference
Time frame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program and Health Mindset modified diabetes prevention program in people with Diabetes Mellitus, Type 2, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Mindset (time frame: baseline, 6 weeks after baseline, and immediately after the intervention (11 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.