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

NCT ID: NCT06671652

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-24
• Study Completion Date: 2024-06-01

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.

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Duyugoda igalenisodi (Starting again the right way)

Intervention Type: BEHAVIORAL

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

Interventions

Duyugoda igalenisodi (Starting again the right way)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Citizen of Cherokee tribe

Exclusion Criteria

• Under the age of 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Melissa Lewis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Lewis

Role: PRINCIPAL_INVESTIGATOR

University of Missouri School of Medicine

Locations

Cherokee Nation

Tahlequah, Oklahoma, United States

Countries

United States

Other Identifiers

2097784

Identifier Type: -

Identifier Source: org_study_id