Cholesterol, ElevatedCIRCLENCT06230705
Community Intervention to Improve CVD Risk Factor Control in Young American Indians
A study testing Guided management and Self management in people with Cholesterol, Elevated and Diabetes Mellitus, run by University of Oklahoma at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cholesterol, Elevated, Diabetes Mellitus
- What is being tested?
- Guided management and Self management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Oklahoma Heath Sciences Center
Oklahoma City, Oklahoma, 73104
Assistant Professor of Research, 405-271-4222, Jessica-Reese@ouhsc.edu
Assistant Professor of Research
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cholesterol, Elevated, Diabetes Mellitus
- Being tested
- Guided management, Self management
- Keywords
- Elevated Cholesterol, Diabetes Mellitus, Cardiovascular Disease, American Indian, Young Adult
- Medical subject headings
- Hypercholesterolemia, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided managementOther
Guided Management
Self managementOther
Self management
| Study group | Role | What they receive |
|---|---|---|
| Guided management | Experimental | 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 Receives: Other: Guided management |
| Self-managed | Active comparator | 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. Receives: Other: Self management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Levels
LDL cholesterol
Measured: 9 and 18 months
Glucose Levels
Fasting glucose
Measured: 9 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Cholesterol, ElevatedStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jessica A Reese, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230705
- Sponsor's protocol ID
- 118014
- Acronym
- CIRCLE
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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."
Publications
Lee ET, Welty TK, Fabsitz R, Cowan LD, Le NA, Oopik AJ, Cucchiara AJ, Savage PJ, Howard BV. The Strong Heart Study. A study of cardiovascular disease in American Indians: design and methods. Am J Epidemiol. 1990 Dec;132(6):1141-55. doi: 10.1093/oxfordjournals.aje.a115757.
PubMed 2260546Howard BV, Lee ET, Cowan LD, Devereux RB, Galloway JM, Go OT, Howard WJ, Rhoades ER, Robbins DC, Sievers ML, Welty TK. Rising tide of cardiovascular disease in American Indians. The Strong Heart Study. Circulation. 1999 May 11;99(18):2389-95. doi: 10.1161/01.cir.99.18.2389.
PubMed 10318659Cross SH, Califf RM, Warraich HJ. Rural-Urban Disparity in Mortality in the US From 1999 to 2019. JAMA. 2021 Jun 8;325(22):2312-2314. doi: 10.1001/jama.2021.5334.
PubMed 34100876Lee ET, Cowan LD, Welty TK, Sievers M, Howard WJ, Oopik A, Wang W, Yeh J, Devereux RB, Rhoades ER, Fabsitz RR, Go O, Howard BV. All-cause mortality and cardiovascular disease mortality in three American Indian populations, aged 45-74 years, 1984-1988. The Strong Heart Study. Am J Epidemiol. 1998 Jun 1;147(11):995-1008. doi: 10.1093/oxfordjournals.aje.a009406.
PubMed 9620042Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139Reese J, Roman MJ, Deen J, Ali T, Cole S, Devereux RB, Fretts AM, Howard BV, Howard WJ, Lee ET, et al. Abstract P040: Dyslipidemia And The Incidence Of Subclinical And Clinical Cardiovascular Disease In Adolescents And Young Adults: The Strong Heart Family Study (SHFS). Circulation. 2022;145:AP040-AP040. doi:doi:10.1161/circ.145.suppl_1.P040
De Marco M, de Simone G, Roman MJ, Chinali M, Lee ET, Calhoun D, Howard BV, Devereux RB. Cardiac geometry and function in diabetic or prediabetic adolescents and young adults: the Strong Heart Study. Diabetes Care. 2011 Oct;34(10):2300-5. doi: 10.2337/dc11-0191. Epub 2011 Aug 26.
PubMed 21873564Lee JS, Chang PY, Zhang Y, Kizer JR, Best LG, Howard BV. Triglyceride and HDL-C Dyslipidemia and Risks of Coronary Heart Disease and Ischemic Stroke by Glycemic Dysregulation Status: The Strong Heart Study. Diabetes Care. 2017 Apr;40(4):529-537. doi: 10.2337/dc16-1958. Epub 2017 Jan 25.
PubMed 28122840Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285-e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov 10. No abstract available.
PubMed 30423393Zhang Y, Galloway JM, Welty TK, Wiebers DO, Whisnant JP, Devereux RB, Kizer JR, Howard BV, Cowan LD, Yeh J, Howard WJ, Wang W, Best L, Lee ET. Incidence and risk factors for stroke in American Indians: the Strong Heart Study. Circulation. 2008 Oct 7;118(15):1577-84. doi: 10.1161/CIRCULATIONAHA.108.772285. Epub 2008 Sep 22.
PubMed 18809797Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA. 2008 Apr 9;299(14):1678-89. doi: 10.1001/jama.299.14.1678.
PubMed 18398080Howard WJ, Russell M, Fleg JL, Mete M, Ali T, Devereux RB, Galloway JM, Otvos JD, Ratner RE, Roman MJ, Silverman A, Umans JG, Weissman NJ, Wilson C, Howard BV. PREVENTION OF ATHEROSCLEROSIS WITH LDL-C LOWERING - LIPOPROTEIN CHANGES AND INTERACTIONS: THE SANDS STUDY. J Clin Lipidol. 2009 Oct 1;3(5):322-331. doi: 10.1016/j.jacl.2009.09.001.
PubMed 20161568de Simone G, Devereux RB, Chinali M, Best LG, Lee ET, Galloway JM, Resnick HE; Strong Heart Study Investigators. Prognostic impact of metabolic syndrome by different definitions in a population with high prevalence of obesity and diabetes: the Strong Heart Study. Diabetes Care. 2007 Jul;30(7):1851-6. doi: 10.2337/dc06-2152. Epub 2007 Apr 17.
PubMed 17440172Reese JA, Roman MJ, Deen JF, Ali T, Cole SA, Devereux RB, Fretts AM, Howard BV, Lee ET, Malloy K, Singh P, Umans JG, Zhang Y. Subclinical atherosclerosis in adolescents and young adults and the risk of cardiovascular disease: The Strong Heart Family Study (SHFS). Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1863-1871. doi: 10.1016/j.numecd.2022.04.024. Epub 2022 May 10.
PubMed 35680485Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
PubMed 35766027
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Intervention to impRove CVD Risk Factor controL in Young AmErican Indians: The CIRCLE Study
- ClinicalTrials.gov ID
- NCT06230705
- Acronym / sponsor ID
- CIRCLE / 118014
- Conditions
- Cholesterol, Elevated, Diabetes Mellitus
- Keywords
- Elevated Cholesterol, Diabetes Mellitus, Cardiovascular Disease, American Indian, Young Adult
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided management | Experimental | Other: Guided managementThe 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 |
| Self-managed | Active comparator | Other: Self managementSelf-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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Guided managementGuided Management | Other | Guided management |
| Self managementSelf management | Other | Self-managed |
Primary outcome
Lipid Levels
Time frame: 9 and 18 months
LDL cholesterol
Glucose Levels
Time frame: 9 and 18 months
Fasting glucose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 2260546Lee ET, Welty TK, Fabsitz R, Cowan LD, Le NA, Oopik AJ, Cucchiara AJ, Savage PJ, Howard BV. The Strong Heart Study. A study of cardiovascular disease in American Indians: design and methods. Am J Epidemiol. 1990 Dec;132(6):1141-55. doi: 10.1093/oxfordjournals.aje.a115757.
- Background: PubMed 10318659Howard BV, Lee ET, Cowan LD, Devereux RB, Galloway JM, Go OT, Howard WJ, Rhoades ER, Robbins DC, Sievers ML, Welty TK. Rising tide of cardiovascular disease in American Indians. The Strong Heart Study. Circulation. 1999 May 11;99(18):2389-95. doi: 10.1161/01.cir.99.18.2389.
- Background: PubMed 34100876Cross SH, Califf RM, Warraich HJ. Rural-Urban Disparity in Mortality in the US From 1999 to 2019. JAMA. 2021 Jun 8;325(22):2312-2314. doi: 10.1001/jama.2021.5334.
- Background: PubMed 9620042Lee ET, Cowan LD, Welty TK, Sievers M, Howard WJ, Oopik A, Wang W, Yeh J, Devereux RB, Rhoades ER, Fabsitz RR, Go O, Howard BV. All-cause mortality and cardiovascular disease mortality in three American Indian populations, aged 45-74 years, 1984-1988. The Strong Heart Study. Am J Epidemiol. 1998 Jun 1;147(11):995-1008. doi: 10.1093/oxfordjournals.aje.a009406.
- Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
- BackgroundReese J, Roman MJ, Deen J, Ali T, Cole S, Devereux RB, Fretts AM, Howard BV, Howard WJ, Lee ET, et al. Abstract P040: Dyslipidemia And The Incidence Of Subclinical And Clinical Cardiovascular Disease In Adolescents And Young Adults: The Strong Heart Family Study (SHFS). Circulation. 2022;145:AP040-AP040. doi:doi:10.1161/circ.145.suppl_1.P040
- Background: PubMed 21873564De Marco M, de Simone G, Roman MJ, Chinali M, Lee ET, Calhoun D, Howard BV, Devereux RB. Cardiac geometry and function in diabetic or prediabetic adolescents and young adults: the Strong Heart Study. Diabetes Care. 2011 Oct;34(10):2300-5. doi: 10.2337/dc11-0191. Epub 2011 Aug 26.
- Background: PubMed 28122840Lee JS, Chang PY, Zhang Y, Kizer JR, Best LG, Howard BV. Triglyceride and HDL-C Dyslipidemia and Risks of Coronary Heart Disease and Ischemic Stroke by Glycemic Dysregulation Status: The Strong Heart Study. Diabetes Care. 2017 Apr;40(4):529-537. doi: 10.2337/dc16-1958. Epub 2017 Jan 25.
- Background: PubMed 30423393Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):e285-e350. doi: 10.1016/j.jacc.2018.11.003. Epub 2018 Nov 10. No abstract available.
- Background: PubMed 18809797Zhang Y, Galloway JM, Welty TK, Wiebers DO, Whisnant JP, Devereux RB, Kizer JR, Howard BV, Cowan LD, Yeh J, Howard WJ, Wang W, Best L, Lee ET. Incidence and risk factors for stroke in American Indians: the Strong Heart Study. Circulation. 2008 Oct 7;118(15):1577-84. doi: 10.1161/CIRCULATIONAHA.108.772285. Epub 2008 Sep 22.
- Background: PubMed 18398080Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA. 2008 Apr 9;299(14):1678-89. doi: 10.1001/jama.299.14.1678.
- Background: PubMed 20161568Howard WJ, Russell M, Fleg JL, Mete M, Ali T, Devereux RB, Galloway JM, Otvos JD, Ratner RE, Roman MJ, Silverman A, Umans JG, Weissman NJ, Wilson C, Howard BV. PREVENTION OF ATHEROSCLEROSIS WITH LDL-C LOWERING - LIPOPROTEIN CHANGES AND INTERACTIONS: THE SANDS STUDY. J Clin Lipidol. 2009 Oct 1;3(5):322-331. doi: 10.1016/j.jacl.2009.09.001.
- Strong Heart Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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."
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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.
Jessica A Reese, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided management and Self management in people with Cholesterol, Elevated and Diabetes Mellitus, run by University of Oklahoma 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica A Reese, PhD (4052712229, Jessica-Reese@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Levels (time frame: 9 and 18 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 NCT06230705, which also lists 58 linked publications.
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 3 Feb 2025.