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Not yet recruiting Not applicable Interventional

Community Intervention to Improve CVD Risk Factor Control in Young American Indians

ClinicalTrials.gov ID: NCT06230705

Public ClinicalTrials.gov record NCT06230705. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 1:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Community Intervention to impRove CVD Risk Factor controL in Young AmErican Indians: The CIRCLE Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

American Indians are more likely to die from heart disease compared to other people in the United States. High levels of fat (lipids) and sugar (glucose) in the blood are related to heart disease. Young American Indians who are 18 to 39 years old have high lipid and glucose levels. This has led to heart disease later in life. This means they are likely to benefit from a program to lower these levels. In this project, researchers will work with American Indians in rural southwestern Oklahoma. The researchers will start by asking American Indians how they would like to design a program for younger members of their community. After getting permission, the researchers will take a small amount of blood from young community members. The researchers will measure lipid and glucose levels and ask those with high levels to be in the study. Then the researchers will do several measurements. These will include blood pressure, height, weight, diet, physical activity, sleep, tobacco and alcohol use, access to health care, and social support. The researchers will compare these measurements to similar measurements taken from young American Indians 20 years ago, collected through the Strong Heart Study, which is the longest running study measuring heart disease in American Indians. Next, the researchers want to know if the program they developed with the American Indian communities will work. To do this, they will put people in one of two groups. They will decide which group each person will be in using a process that is like flipping a coin (heads for one group, tails for the other group). One group will receive educational booklets about how to avoid getting heart disease. The other group will receive help from a community health worker. The community health worker will help participants to get to the doctor for treatment. They will also help participants change their diet and exercise routines and provide education about heart disease risk factors. After 9 and 18 months, the researchers will repeat the measurements to see if one of the groups has lower lipid or glucose levels. This program will support the National Heart, Lung, and Blood Institute's mission to "reduce human disease" by lowering lipid and glucose levels, which are related to getting heart disease. This will be done by using the community health worker model to help people go to the doctor and improve their lifestyle related to diet and exercise. The researchers will also be able to advance heart health in American Indians in rural Oklahoma by lowering factors related to heart disease.

Study identification

NCT ID
NCT06230705
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Oklahoma
Other
Enrollment
360 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 39 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2025
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029
Last update posted
Feb 2, 2025

2025 – 2029

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Oklahoma Heath Sciences Center Oklahoma City Oklahoma 73104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06230705, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 2, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06230705 live on ClinicalTrials.gov.

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