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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Behavioral: Duyugoda igalenisodi (Starting again the right way)

Detailed Description

1. Identify necessary program enhancements to maximize reach and acceptability of the intervention for primary prevention of CVD in Cherokee Nation adults. The new intervention will have a broad reach, and thus, potentially greater public health impact. By building on the well-established and popular intervention, RTR, the goal is to maximize the likelihood that this intervention will be culturally acceptable, logistically feasible, and financially sustainable.
2. Conduct a pilot study (n = 40) to demonstrate acceptability and feasibility of the adapted intervention and research methods. The expectation is that the intervention will be culturally acceptable to participants, and retention and data collection protocols will support feasibility of a larger randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tahlequah, Oklahoma, United States, 74464
      • Cherokee Nation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Citizen of Cherokee tribe

Exclusion Criteria:

• Under the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Duyugoda igalenisodi (Starting again the right way); Participants in the intervention arm will receive training and resources to build community resources and programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa Lewis, University of Missouri School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2097784; K01HL142944 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No