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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL142944 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a two phase project. Phase I is an online convenience sample to collect health and preference data for the intervention phase, as well as a partnership with community to co-create an intervention; Phase II. Phase II is an intervention to improve community connection and historical knowledge within Cherokee communities within the Cherokee Nation reservation involving consultation with Cherokee cultural and historical experts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duyugoda igalenisodi (Starting again the right way) | Behavioral | Participants in the intervention arm will receive training and resources to build community resources and programming |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG) | Pre; Post (study completion; within 6 months) |
| Weight | Weight was gathered from participants using a digital scale and measured in pounds. | Pre;Post |
| Measure | Description | Time Frame |
|---|---|---|
| Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale") | [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. | Pre; Post (study completion; within 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Lewis | University of Missouri School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cherokee Nation | Tahlequah | Oklahoma | 74464 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG) | Posted | Mean | Standard Deviation | mmHg | Pre; Post (study completion; within 6 months) |
|
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | No adverse events reported | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Lewis | University of Missouri School of Medicine | 5738822782 | lewismeli@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2024 | Jul 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2025 | Sep 24, 2025 | ICF_001.pdf |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Weight was gathered from participants using a digital scale. | Mean | Standard Deviation | pounds |
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| Primary | Weight | Weight was gathered from participants using a digital scale and measured in pounds. | Posted | Mean | Standard Deviation | Pounds | Pre;Post |
|
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|
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| Secondary | Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale") | [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. | Posted | Mean | Standard Deviation | score on a scale | Pre; Post (study completion; within 6 months) |
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| Post-Hoc | Cultural Efficacy-abbreviated Version | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre; Post (study completion; within 6 months) |
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| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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