Trial Outcomes & Findings for Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk (NCT NCT06671652)
NCT ID: NCT06671652
Last Updated: 2026-03-13
Results Overview
Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG)
COMPLETED
NA
42 participants
Pre; Post (study completion; within 6 months)
2026-03-13
Participant Flow
Recruitment will occur using a publicly available website, CN Facebook page, the RTR Facebook page, and flyers at physical locations, including approved tribal complex buildings, and recruitment at community centers. Interested individuals will be asked to submit an online application using Research Electronic Data Capture (REDCapTM) (however paper copies will be accepted at request of applicant if needed but will be uploaded to REDCapTM), which will then be used to assess eligibility.
Participant milestones
| Measure |
Intervention
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Overall Study
STARTED
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42
|
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Overall Study
COMPLETED
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28
|
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Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Intervention
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Overall Study
Lost to Follow-up
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14
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Baseline Characteristics
Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk
Baseline characteristics by cohort
| Measure |
Intervention
n=42 Participants
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Age, Continuous
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42 years
n=41 Participants
|
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Sex/Gender, Customized
Gender · Female
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28 Participants
n=41 Participants
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Sex/Gender, Customized
Gender · Male
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12 Participants
n=41 Participants
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Sex/Gender, Customized
Gender · Other
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2 Participants
n=41 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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42 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Region of Enrollment
United States
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42 Participants
n=41 Participants
|
|
Weight
|
227.69 pounds
STANDARD_DEVIATION 61.02 • n=41 Participants
|
PRIMARY outcome
Timeframe: Pre; Post (study completion; within 6 months)Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG)
Outcome measures
| Measure |
Intervention
n=26 Participants
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
|
|---|---|
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Blood Pressure
Systolic-Pre
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126.7 mmHg
Standard Deviation 18.93
|
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Blood Pressure
Systolic-Post
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127.7 mmHg
Standard Deviation 19.13
|
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Blood Pressure
Diastolic-Pre
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87.20 mmHg
Standard Deviation 12.80
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Blood Pressure
Diastolic-Post
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88.15 mmHg
Standard Deviation 11.97
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PRIMARY outcome
Timeframe: Pre;PostWeight was gathered from participants using a digital scale and measured in pounds.
Outcome measures
| Measure |
Intervention
n=26 Participants
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Weight
Weight-Pre
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227.69 Pounds
Standard Deviation 61.02
|
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Weight
Weight-Post
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220.92 Pounds
Standard Deviation 54.67
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SECONDARY outcome
Timeframe: Pre; Post (study completion; within 6 months)\[1-6\] for a single item, and 14 - 84 for total score for all items summed. Higher scores indicate better outcomes, specifically, flourishing mental health.
Outcome measures
| Measure |
Intervention
n=26 Participants
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")
CE-Post
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67.69 score on a scale
Standard Deviation 12.59
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Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")
CE-Pre
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63.38 score on a scale
Standard Deviation 14.10
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POST_HOC outcome
Timeframe: Pre; Post (study completion; within 6 months)The purpose of the measure is to calculate the current state of self-reported cultural efficacy which is a measure of an individual's confidence in their ability to engage with their own culture. There were 5 questions in this version. Measure responses for this scale range from 1 (Strongly disagree) to 5 (Strongly Agree) for each response. A summary score was created by totaling each item response (1-5) for each participant multiplied by the 5 questions they completed for a total summary score that would have a maximum of 25 (5x5) and a minimum possible score of 5 (1x5). The higher the score, the better cultural efficacy. Participants in each group (pre/post) total summary scores were averaged for comparison.
Outcome measures
| Measure |
Intervention
n=26 Participants
Participants will take part in a community building program in which Cherokee cultural, linguistic, and historical experts will met with the self-selected community groups approximately 1 x month for 5 months. Participants will complete homework assignments for each meeting and will complete a final presentation on the history and culture of their families and communities.
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|---|---|
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Cultural Efficacy-abbreviated Version
Pre
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19.73 units on a scale
Standard Deviation 4.45
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Cultural Efficacy-abbreviated Version
Post
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21.61 units on a scale
Standard Deviation 2.51
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Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place