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

January 31, 2025 updated by: University of Oklahoma

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) incidence in American Indians is more than two-fold higher than the age-matched United States (US) population, and significantly associated with elevated lipids/lipoproteins and glucose levels. Through systematic surveillance conducted by the Strong Heart Study (SHS), the largest and longest running study of CVD in American Indians, we report that elevated lipid/lipoprotein prevalence for participants <20, 20-29, and 30-39 years old was 55.2%, 73.6%, and 78.0%, respectively. In addition, we report that American Indians under 40 years old with elevated LDL cholesterol had a three-fold greater independent risk of subclinical atherosclerosis five (5) years later and/or incident, clinical CVD 20 years later. Although statin therapy is effective for dyslipidemia, the rates of use are low among American Indians, with less than 50% of young SHS participants with primary hypercholesterolemia receiving treatment. In addition, the high diabetes prevalence (8%) in young American Indians contributes to high rates of CVD, where incidence of atherosclerosis was 41.3 per 1,000 person-years in diabetics compared to 16.3 per 1,000 person-years in non-diabetics (p<0.001). These elevated lipid/lipoprotein and glucose levels may be due to limited health care access and lifestyle factors such as nutrition, physical activity, sleep hygiene, and social determinants of health (SDOH), including social support. As a result, there is a critical need to measure these factors and include them in a culturally appropriate intervention to control lipid/lipoprotein and glucose levels and thereby reduce CVD.

The long-term goal of this research, which aligns with the NHLBI's strategic goal to "reduce human disease," is to reduce incident CVD risk in American Indians. Our overall objective is to determine the effectiveness of a culturally appropriate intervention, designed with American Indian involvement, to control lipid/lipoprotein and glucose levels. To achieve this objective, we will determine the effectiveness of a guided intervention. Before determining the intervention effectiveness, we will use a community-engaged approach and conduct focus groups asking participants to offer recommendations for a modified version of the Balance Study that we conducted with older (mean age=52 years) American Indians in Oklahoma, 2008-2012. Subsequently, we will recruit 360 American Indians, 18-39 years old, with elevated lipid/lipoprotein or glucose levels. Among this group, we will assess baseline CVD risk factors and then randomly assign them to either a self-managed control group receiving health care referrals and educational materials or to an 18-month guided intervention group, incorporating: 1) community health workers (CHW) to reduce health care access barriers and 2) a multidimensional component focusing on nutrition, physical activity, and CVD risk factor education during at least six (6) quarterly in-person meetings. Based on the Balance Study and SHS, we formulated the central hypothesis that health care access, nutrition, physical activity, and CVD risk factor education jointly contribute to lipid/lipoprotein and glucose control. Therefore, the rationale for the proposed research is to include these components in an intervention targeting lipid/lipoprotein and glucose management. Given our experience with American Indian communities recruiting and designing interventions for the SHS, we are well-positioned to conduct this research, with the following Specific Aims:

Aim 1: (A) To work with CHWs, healthcare workers, community leaders, and community members to adapt a culturally relevant CVD risk factor intervention based on the Balance Study for American Indians, 18-39 years old. (B) To assess the acceptability of the adapted intervention among American Indians, 18-39 years old from communities participating in the Strong Heart Study in southwestern Oklahoma. We will work with members of the community to adapt a lifestyle intervention for younger populations that was previously used in older populations of American Indians, titled the Balance Study. Then we will conduct focus groups among American Indians who are 18-29 or 30-39 to determine the acceptability of adapted intervention among these groups.

Aim 2: To determine if the adapted 18-month guided intervention is more effective than self-management at lowering LDL-C or glucose levels, among American Indians, with serum LDL-C ≥100 mg/dL and/or fasting plasma glucose ≥126 mg/dL who are 18-39 years old from communities participating in the Strong Heart Study in southwestern Oklahoma. Hypothesis: American Indians, 18-39 years old, randomized to the guided intervention, will have at least a 10% reduction in LDL-C and/or glucose levels after 18 months.

The proposed research will determine the effectiveness of an intervention that uses the CHW model to target health care access, nutrition, physical activity, and CVD risk factor education within the young adult American Indian population. The expected outcomes include the refinement of a culturally appropriate CVD risk factor reduction intervention and the reduction of LDL-C and glucose levels in young American Indians with elevated CVD risk. This study will decrease the disproportionately high lipid/lipoprotein and glucose levels that are significantly predictive of incident CVD in young American Indians.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Heath Sciences Center
        • Contact:
        • Principal Investigator:
          • Assistant Professor of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Indians
  • 18-39 years old
  • Members of the tribal communities that participate in the Strong Heart Study in southwestern Oklahoma
  • Only one person per household will be eligible

Exclusion Criteria:

  • Are unwilling or unable to follow the intervention, which includes modifying current nutritional intake and participating in the proposed physical activity program
  • Are taking lipid-/lipoprotein-lowering or diabetes medication
  • Are already participating in a diabetes or CVD risk factor reduction program
  • Are pregnant or plan to become pregnant in the next 18 months
  • Are not English speaking
  • Are institutionalized
  • Have underlying disease with a life-expectancy of less than 2 years (e.g., cancer or end stage renal disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided management

The intervention will be comprised of four broad components (described below). The focus groups will inform these components and therefore, we propose a community-responsive and ultimately, community-driven intervention.

  1. Component on reducing barriers to health care access
  2. Nutritional component
  3. Activity component
  4. CVD risk factor education component
Other: Guided management
Guided Management
Active Comparator: Self-managed
Self-managed (control group): For participants randomized to the self-managed group, we will employ the standard of care that is currently used by the Strong Heart Study (SHS) and other large cohorts, which is based on a referral program for risk factor control and dissemination of educational pamphlets. Therefore, the risk factor control and education for this group will be self-managed.
Other: Self management
Self management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Levels
Time Frame: 9 and 18 months
Fasting glucose
9 and 18 months
Lipid Levels
Time Frame: 9 and 18 months
LDL cholesterol
9 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jessica A Reese, PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118014
  • 1583055 (Other Grant/Funding Number: NHLBI Application Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be collected, analyzed, and reported under agreements made with the sovereign tribal nations that have partnered in this research, which preclude commonly accepted modes of data sharing. Requests will be reviewed by tribal research partners before data may be released. This policy is consistent with the "NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data."

IPD Sharing Time Frame

3 years after the end of the study period. Data will be available after tribal approval.

IPD Sharing Access Criteria

Tribal approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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