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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Pre; Post (study completion; within 6 months)

Results posted on

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

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.
Overall Study
STARTED
42
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
14

Reasons for withdrawal

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.
Overall Study
Lost to Follow-up
14

Baseline Characteristics

Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk

Baseline characteristics by cohort

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.
Age, Continuous
42 years
n=41 Participants
Sex/Gender, Customized
Gender · Female
28 Participants
n=41 Participants
Sex/Gender, Customized
Gender · Male
12 Participants
n=41 Participants
Sex/Gender, Customized
Gender · Other
2 Participants
n=41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
42 Participants
n=41 Participants
Race (NIH/OMB)
Asian
0 Participants
n=41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=41 Participants
Race (NIH/OMB)
White
0 Participants
n=41 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
Region of Enrollment
United States
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

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.
Blood Pressure
Systolic-Pre
126.7 mmHg
Standard Deviation 18.93
Blood Pressure
Systolic-Post
127.7 mmHg
Standard Deviation 19.13
Blood Pressure
Diastolic-Pre
87.20 mmHg
Standard Deviation 12.80
Blood Pressure
Diastolic-Post
88.15 mmHg
Standard Deviation 11.97

PRIMARY outcome

Timeframe: Pre;Post

Weight was gathered from participants using a digital scale and measured in pounds.

Outcome measures

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.
Weight
Weight-Pre
227.69 Pounds
Standard Deviation 61.02
Weight
Weight-Post
220.92 Pounds
Standard Deviation 54.67

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

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.
Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")
CE-Post
67.69 score on a scale
Standard Deviation 12.59
Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")
CE-Pre
63.38 score on a scale
Standard Deviation 14.10

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

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.
Cultural Efficacy-abbreviated Version
Pre
19.73 units on a scale
Standard Deviation 4.45
Cultural Efficacy-abbreviated Version
Post
21.61 units on a scale
Standard Deviation 2.51

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Lewis

University of Missouri School of Medicine

Phone: 5738822782

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place