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Completed

NCT Number: NCT06671652

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.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cherokee Nation

Tahlequah, Oklahoma, 74464, United States

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Citizen of Cherokee tribe

Exclusion criteria

  • Under the age of 18

Treatment and study plan

Duyugoda igalenisodi (Starting again the right way)

Behavioral

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

Primary outcomes

  1. Blood Pressure

    Time frame: Pre; Post (study completion; within 6 months)

    Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG)

  2. Weight

    Time frame: Pre;Post

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

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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