Blood PressureNCT06671652

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

A study testing Duyugoda igalenisodi (Starting again the right way) in people with Blood Pressure, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: Duyugoda igalenisodi (Starting again the right way)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2023to 1 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Citizen of Cherokee tribe

Who cannot join

Under the age of 18

Trial locations and contacts

1 site in 1 country.

United States1 site

Cherokee Nation
Tahlequah, Oklahoma, 74464

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Blood Pressure
Being tested: Duyugoda igalenisodi (Starting again the right way)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06671652
Study group	Role	What they receive
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. Receives: Behavioral: Duyugoda igalenisodi (Starting again the right way)

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Pressure
Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG)
Measured: Pre; Post (study completion; within 6 months)
Weight
Weight was gathered from participants using a digital scale and measured in pounds.
Measured: Pre;Post

Secondary outcomes (1)

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.
Measured: Pre; Post (study completion; within 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 20231 Jun 2024

First posted4 Nov 2024
Study start24 Sep 2023
Primary completion1 Jun 2024
Study completion1 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06671652
Sponsor's protocol ID: 2097784
Other IDs: K01HL142944
Status last verified: Jan 2026
First submitted: 19 Dec 2023
Last updated: 13 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk
ClinicalTrials.gov ID: NCT06671652
Acronym / sponsor ID: 2097784
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 24 Sep 2023 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 4 Nov 2024 (actual)
Results: Posted 13 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Behavioral: Duyugoda igalenisodi (Starting again the right way)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Citizen of Cherokee tribe

Key exclusion criteria (1 listed)

Under the age of 18

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Duyugoda igalenisodi (Starting again the right way)Participants in the intervention arm will receive training and resources to build community resources and programming	Behavioural	Intervention

Primary outcome

Blood Pressure
Time frame: Pre; Post (study completion; within 6 months)
Systolic and Diastolic blood pressure measured through millimeters of mercury (mmHG)
Weight
Time frame: Pre;Post
Weight was gathered from participants using a digital scale and measured in pounds.

1 secondary outcome

Keyes Mental Health Continuum, Short Form (Also Known as "Positive Mental Health Scale")
Time frame: Pre; Post (study completion; within 6 months)

Results and safety

Results posted to the registry on 13 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	42	28

Primary outcome: Blood Pressure

Time frame: Pre; Post (study completion; within 6 months). Mean (Standard Deviation). Unit: mmHg

Measure	Intervention n = 26
Systolic-Pre	126.7 (18.93)
Systolic-Post	127.7 (19.13)
Diastolic-Pre	87.20 (12.80)
Diastolic-Post	88.15 (11.97)

Intervention: Mean Difference (Final Values): 1, p = .91, t-test, 2 sided

Primary outcome: Weight

Time frame: Pre;Post. Mean (Standard Deviation). Unit: Pounds

Measure	Intervention n = 26
Weight-Pre	227.69 (61.02)
Weight-Post	220.92 (54.67)

Intervention: Median Difference (Final Values): -6.77, p = .08, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Blood Pressure

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingPhase 3
A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity
Hypertension, Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Lewis principal investigator

University of Missouri School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Duyugoda igalenisodi (Starting again the right way) in people with Blood Pressure, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Pre; Post (study completion; within 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.