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Search / Trial NCT06230705

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

Launched by UNIVERSITY OF OKLAHOMA · Jan 19, 2024

Trial Information

Current as of June 12, 2025

Not yet recruiting

Keywords

Elevated Cholesterol Diabetes Mellitus Cardiovascular Disease American Indian Young Adult

ClinConnect Summary

This clinical trial is focused on helping young American Indians, aged 18 to 39, reduce their risk of heart disease by improving their cholesterol and blood sugar levels. Researchers will work with communities in rural southwestern Oklahoma to design a program that fits their needs. They will first collect some blood samples to measure lipid (fat) and glucose (sugar) levels, and then compare these results with data from young American Indians collected 20 years ago. The goal is to see how effective a community-based program can be in lowering these levels and supporting heart health.

To participate, you must be an American Indian between 18 and 39 years old and a member of a tribal community involved in the Strong Heart Study. Only one person per household can take part. During the trial, participants will be randomly assigned to one of two groups: one will receive educational booklets about heart disease prevention, while the other will work with a community health worker who will assist them in visiting doctors and making healthier lifestyle choices, like better eating habits and more physical activity. Over 9 and 18 months, the researchers will check to see if these efforts have led to improvements in cholesterol and blood sugar levels, ultimately aiming to reduce the risk of heart disease in young American Indians.

Gender

ALL

Eligibility criteria

  • 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).

About University Of Oklahoma

The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.

Locations

Oklahoma City, Oklahoma, United States

Patients applied

0 patients applied

Trial Officials

Jessica A Reese, PhD

Principal Investigator

University of Oklahoma

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported