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

NCT06671652 | Completed Results DMC

• 2 other identifiers: 2097784K01HL142944
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")

  Pre; Post (study completion; within 6 months)

Study Arms (1)

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.

Behavioral: Duyugoda igalenisodi (Starting again the right way)

Interventions

Duyugoda igalenisodi (Starting again the right way) BEHAVIORAL

Participants in the intervention arm will receive training and resources to build community resources and programming

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Citizen of Cherokee tribe

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cherokee Nation

Tahlequah, Oklahoma, 74464, United States

Location

Results Point of Contact

• Title: Melissa Lewis
• Organization: University of Missouri School of Medicine

lewismeli@health.missouri.edu

5738822782

Study Officials

• Melissa Lewis

  University of Missouri School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: November 4, 2024
• Study Start: September 24, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-01

Locations

US (1)