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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Westat | OTHER |
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WEAVE NM (Wide Engagement for Assessing Vaccine Equity in New Mexico) is a community-based research initiative working to improve health outcomes in underserved populations, with a current focus on hypertension and food justice. The project centers on the lived experiences of Native American, African American, Hispanic/Latino, and Asian American residents in Albuquerque's International District and South Valley. With guidance from community voices and ongoing collaboration with local organizations, health providers, and residents, the initiative integrates cultural values, public policy, and social realities into solutions that promote equity and wellness.
As part of this work, a clinical trial is being conducted through First Nations Community HealthSource (FNCH) to evaluate a culturally tailored blood pressure intervention called Heart Health and Nutrition for Life (HHNL). The trial includes patients who receive standard hypertension care and blood pressure self-monitoring, with one group also participating in a community health worker-led educational program in their first six months of study enrollment. This curriculum addresses healthy eating, physical activity, medication adherence, stress reduction, and avoidance of alcohol and tobacco, all delivered with cultural sensitivity and community insight. After six months, the groups switch roles, allowing all participants to receive the education component.
Participants' progress is measured over a 12-month period by tracking changes in blood pressure, cholesterol, weight, blood sugar (HbA1c), and emotional well-being. The aim is to determine whether this community-supported approach improves outcomes more effectively than standard care alone with blood pressure self-monitoring. This study represents a broader effort to create long-term, community-rooted solutions to chronic health issues by addressing the social and environmental factors that influence well-being.
For individuals living in the International District or South Valley, this project offers the opportunity to take part in research that respects cultural identity and prioritizes real-world impact on health. Interested patients and families can contact their provider at FNCH to learn more about participation.
HHNL is a two-arm, randomized, controlled trial with two study phases and an active control condition, enrolling 240 adults with hypertension from First Nations Community HealthSource (FNCH), including Native American, Latinx, African American, and Asian American participants. All receive education, blood pressure monitors, and study questionnaires.
This clinical trial component is designed to evaluate whether a healthy lifestyle program led by community health workers-called Heart Health and Nutrition for Life (HHNL)-improves blood pressure control more effectively than standard care with blood pressure self-monitoring alone. The HHNL program includes blood pressure self-monitoring and culturally tailored education sessions. The trial is being conducted with patients receiving care at First Nations Community HealthSource (FNCH), a federally qualified health center serving a varying population in Albuquerque, New Mexico.
Participants are randomly assigned to one of two groups. One group receives the HHNL education program in their first six months of study enrollment, along with FNCH's standard care and blood pressure self-monitoring. The other group receives standard care and blood pressure self-monitoring alone for the first six months, after which they receive the HHNL education program in their second six months of study enrollment. The goal is to compare outcomes over time and between groups to understand the added value of the HHNL program.
The primary focus is on changes in systolic blood pressure over the first six months. Data will be collected at baseline, 3-4 months, and six months to track progress, with data at 3-4 months allowing early insights following the conclusion of the education sessions.
In addition to systolic blood pressure, the study will also examine other health indicators, including diastolic blood pressure, lipid levels (total cholesterol, LDL, HDL, and triglycerides), HbA1c, body mass index (BMI), and psychological distress. Researchers will also assess behavior-related factors such as medication adherence, blood pressure monitoring habits, physical activity, healthy eating, alcohol and tobacco use, and perceptions of health risks and benefits. These outcomes will be analyzed from baseline to six months, with a focus on comparing the two groups and understanding the immediate effects of the intervention.
Over the full 12-month study period, the research team expects to see specific trends within each group. For those starting with the HHNL education program, improvements in health outcomes are anticipated in the first six months, with those gains maintained after transitioning to standard care with blood pressure self-monitoring alone. For participants who begin with standard care with blood pressure self-monitoring alone and later receive the HHNL educational sessions, improvements are expected primarily during the second half of the study.
The trial is being developed and implemented with ongoing input from a Community Advisory Council to ensure cultural relevance, community alignment, and consistent guidance of the research process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HHNL Educational Interventional Arm | Experimental | Arm 1 of this study will consist of individuals initially assigned to the HHNL educational intervention, alongside FNCH standard care with blood pressure self-monitoring, to assess improvements in systolic blood pressure outcomes relative to those initially assigned to FNCH standard care with blood pressure self-monitoring only (Arm 2). The educational intervention is received in the first 6 months for participants within Arm 1. |
|
| Comparator Arm: Standard of Care and Self Blood Pressure Monitoring | Active Comparator | Arm 2 will serve as the active control condition of FNCH standard care supplemented with supported self-measured blood pressure (SMBP). SMBP, itself, is an evidence-based intervention. Inclusion of an active control in this study is designed to facilitate both enhanced participant benefit and enhanced science, while allowing the investigators to assess the add-on impacts of the HHNL expanded primary care intervention more rigorously. Arm 2 receives the educational intervention within the second 6 months of study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Health and Nutrition for Life (HHNL) | Behavioral | The CHW-led educational intervention will draw on two evidence-based programs, Healthy for Life (American Heart Association) and Your Heart, Your Life (NHLBI). Both curricula are designed to be facilitated by community health workers/promotores de salud and have been tested in both English and Spanish. Study-adapted curricular elements will include 12 core educational activities, delivered in six, two-hour, in-person sessions. In the context of expected family and work obligations alongside limited resources of FNCH patients, the investigators anticipate structuring sessions over, at most, 2 months with a class size of approximately 5-15 patients. In the CHW-led educational intervention, participants will learn about topics such as understanding risk for heart disease, the importance of physical activity, affordable healthy eating, and how family members can support health. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Clinically measured blood pressure levels | Baseline measurement and at about 3-, 6-, and 12- month timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure | Clinically measured diastolic blood pressure | Measured at baseline and at about 3-, 6-, and 12-month timepoints. |
| HbA1c | Diabetes Indicator |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of BP self-monitoring | Monthly self-measured BP logs | Monthly: Months 1-12 |
| Adherence to anti-HTN medication | H-SCALE subscale | Months 0, 3, 6 & 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blake Boursaw, MS | Contact | 505-925-4377 | bboursaw@salud.unm.edu | |
| Tassy Parker, PhD, RN | Contact | 505-272-4100 | TaParker@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tassy Parker, PhD, RN | University of New Mexico | Principal Investigator |
| Linda Son-Stone, Ed D, MPH | First Nations Community HealthSource | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Nations Community HealthSource | Recruiting | Albuquerque | New Mexico | 87108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35286164 | Background | Kandzari DE, Mahfoud F, Weber MA, Townsend R, Parati G, Fisher NDL, Lobo MD, Bloch M, Bohm M, Sharp ASP, Schmieder RE, Azizi M, Schlaich MP, Papademetriou V, Kirtane AJ, Daemen J, Pathak A, Ukena C, Lurz P, Grassi G, Myers M, Finn AV, Morice MC, Mehran R, Juni P, Stone GW, Krucoff MW, Whelton PK, Tsioufis K, Cutlip DE, Spitzer E. Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium. Circulation. 2022 Mar 15;145(11):847-863. doi: 10.1161/CIRCULATIONAHA.121.057687. Epub 2022 Mar 14. | |
| 29395265 |
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A de-identified repository will house all data shared with Westat, minus identifiers (e.g., birth month, detailed geographic data), and include additional variables such as BP, BMI, psychological distress, medication adherence, lifestyle behaviors, perceptions, community pride, family cohesion, spiritual practices, and healthcare discrimination.
Scientific data generated during WEAVE NM HHNL will be deposited by the end of the proposed grant funding period or by time of associated publication, whichever comes first. Archiving practices of the chosen data repository will support standardized back up and replication, and all shared scientific data will remain deposited with ongoing monitoring for accessibility for a minimum of three years after the end of the grant funding period.
The WEAVE NM HHNL project is expected to generate individual-level clinical data and self-reported health and process data. This data will be preserved and shared at the unit-of-observation level when permitted by federal, state, local, or Tribal law and where participant privacy and community safety can be maintained. All quantitative data will be de-identified using best practices outlined in the Inter-university Consortium for Political and Social Research's (ICPSR) Guide to Social Science Data Preparation and Archiving, 6th edition, and by applying the HIPAA Safe Harbor method to remove all 18 identifiers from datasets containing protected health information. Accompanying metadata will ensure the data can support both validation of findings and the generation of new analyses. Supporting documentation will include key metadata elements such as study protocols, data collection instruments, and study description.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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Drawing on methodological innovations in the design of community-partnered research and randomized controlled trials, this study will use a multi-wave, two-arm randomized controlled trial with two study phases and an active control condition to measure the effectiveness of the HHNL expanded primary care intervention as compared to First Nations Community HealthSource (FNCH) standard clinical care for hypertension, alongside supported blood pressure self-monitoring.
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|
| Self-Measured Blood Pressure | Behavioral | Self-measured blood pressure (SMBP) is a proven, cost-effective strategy to improve blood pressure control by promoting patient engagement and medication adherence. All study participants will receive the same validated BP monitor, with cuff sizes adjusted as needed, selected from the US Blood Pressure Validated Device Listing. Patients will be trained using the AMA's 7-Step SMBP Quick Guide, consistent with FNCH clinical education practices. They will be asked to record baseline BP readings and complete at least one SMBP cycle per month during the 12-month study. Each cycle includes at least three consecutive days of morning and evening BP measurements. |
|
| Months 0, 3, 6 & 12 |
| BMI | Body Mass Index | Months 0, 3, 6 & 12 |
| Lipid levels (total cholesterol, LDL, HDL, triglycerides) | Cholesterol | Months 0, 3, 6 & 12 |
| Psychological Distress | Kessler Psych Distress scale (K10) | Months 0, 3, 6 & 12 |
| Healthy eating | H-SCALE subscale | Months 0, 3, 6 & 12 |
| Physical Activity Engagement | H-SCALE subscale | Months 0, 3, 6 & 12 |
| Weight management | H-SCALE subscale | Months 0, 3, 6 & 12 |
| Avoiding alcohol and tobacco | H-SCALE subscale | Months 0, 3, 6 & 12 |
| Self-efficacy | Health Belief Model adapted subscale | Months 0, 3, 6 & 12 |
| Perceived susceptibility | Health Belief Model adapted subscale | Months 0, 3, 6 & 12 |
| Perceived severity | Health Belief Model adapted subscale | Months 0, 3, 6 & 12 |
| Perceived benefits | Health Belief Model adapted subscale | Months 0, 3, 6 & 12 |
| Community pride | Adapted single-item behavior change influence outcome | Months 0, 3, 6 & 12 |
| Lisa Cacari Stone, PhD, MS, MA |
| University of New Mexico |
| Principal Investigator |
| Background |
| Ma C. An investigation of factors influencing self-care behaviors in young and middle-aged adults with hypertension based on a health belief model. Heart Lung. 2018 Mar-Apr;47(2):136-141. doi: 10.1016/j.hrtlng.2017.12.001. Epub 2018 Feb 1. |
| 28184154 | Background | Khorsandi M, Fekrizadeh Z, Roozbahani N. Investigation of the effect of education based on the health belief model on the adoption of hypertension-controlling behaviors in the elderly. Clin Interv Aging. 2017 Jan 27;12:233-240. doi: 10.2147/CIA.S117142. eCollection 2017. |
| 31130078 | Background | Warren-Findlow J, Krinner LM, Vinoski Thomas E, Coffman MJ, Gordon B, Howden R. Relative and Cumulative Effects of Hypertension Self-Care Behaviors on Blood Pressure. West J Nurs Res. 2020 Mar;42(3):157-164. doi: 10.1177/0193945919851111. Epub 2019 May 26. |
| 29357392 | Background | Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension Guideline. Ann Intern Med. 2018 Mar 6;168(5):351-358. doi: 10.7326/M17-3203. Epub 2018 Jan 23. |
| 33180688 | Background | Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099. |
| 30202926 | Background | Kwon SC, Tandon SD, Islam N, Riley L, Trinh-Shevrin C. Applying a community-based participatory research framework to patient and family engagement in the development of patient-centered outcomes research and practice. Transl Behav Med. 2018 Sep 8;8(5):683-691. doi: 10.1093/tbm/ibx026. |
| Background | U.S. Department of Health and Human Services. (2008). Your heart, your life: A community health worker's manual. NHLBI. https://www.nhlbi.nih.gov/files/docs/resources/heart/lat_mnl_en.pdf |
| Background | Healthy for Life. www.heart.org. (n.d.). https://www.heart.org/en/healthy-living/companycollaboration/healthy-for-life. |
| 35503165 | Background | Moore KR, Schroeder EB, Goodrich GK, Manson SM, Malone AS, Pieper LE, Son-Stone L, Johnson D, Steiner JF. Racial and Ethnic Equity in Care for Hypertension and Diabetes in an Urban Indian Health Organization. J Racial Ethn Health Disparities. 2023 Jun;10(3):1319-1328. doi: 10.1007/s40615-022-01317-3. Epub 2022 May 3. |
| 30938688 | Background | Schroeder EB, Moore K, Manson SM, Baldwin MA, Goodrich GK, Malone AS, Pieper LE, Xu S, Fort MM, Johnson D, Son-Stone L, Steiner JF. An Interactive Voice Response and Text Message Intervention to Improve Blood Pressure Control Among Individuals With Hypertension Receiving Care at an Urban Indian Health Organization: Protocol and Baseline Characteristics of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e11794. doi: 10.2196/11794. |
| 32564288 | Background | Meador M, Hannan J, Roy D, Whelihan K, Sasu N, Hodge H, Lewis JH. Accelerating Use of Self-measured Blood Pressure Monitoring (SMBP) Through Clinical-Community Care Models. J Community Health. 2021 Feb;46(1):127-138. doi: 10.1007/s10900-020-00858-0. |
| 32584755 | Background | Stupplebeen DA, Pirkle CM, Sentell TL, Nett BMI, Ilagan LSK, Juan B, Medeiros J, Keliikoa LB. Self-Measured Blood Pressure Monitoring: Program Planning, Implementation, and Lessons Learned From 5 Federally Qualified Health Centers in Hawai'i. Prev Chronic Dis. 2020 Jun 25;17:E47. doi: 10.5888/pcd17.190348. |
| 29860640 | Background | Blue Bird Jernigan V, D'Amico EJ, Duran B, Buchwald D. Multilevel and Community-Level Interventions with Native Americans: Challenges and Opportunities. Prev Sci. 2020 Jan;21(Suppl 1):65-73. doi: 10.1007/s11121-018-0916-3. |
| 36524696 | Background | Parker T, Kelley A, Cooeyate N, Tsosie N. Tribal Perspectives on Hypertension: Results From the Center for Native American Health Native-CHART Needs Assessment. J Prim Care Community Health. 2022 Jan-Dec;13:21501319221144269. doi: 10.1177/21501319221144269. |
| 24396118 | Background | Sanchez V, Cacari Stone L, Moffett ML, Nguyen P, Muhammad M, Bruna S, Urias-Chauvin R. Process evaluation of a promotora de salud intervention for improving hypertension outcomes for Latinos living in a rural U.S.-Mexico border region. Health Promot Pract. 2014 May;15(3):356-64. doi: 10.1177/1524839913516343. Epub 2014 Jan 6. |
| 33709805 | Background | Cacari Stone L, Sanchez V, Bruna SP, Muhammad M, Zamora Mph C. Social Ecology of Hypertension Management Among Latinos Living in the U.S.-Mexico Border Region. Health Promot Pract. 2022 Jul;23(4):650-661. doi: 10.1177/1524839921993044. Epub 2021 Mar 12. |
| 27633485 | Background | Baker EA, Barnidge EK, Schootman M, Sawicki M, Motton-Kershaw FL. Adaptation of a Modified DASH Diet to a Rural African American Community Setting. Am J Prev Med. 2016 Dec;51(6):967-974. doi: 10.1016/j.amepre.2016.07.014. Epub 2016 Sep 12. |
| 30905430 | Background | Steinberg D, Kay M, Burroughs J, Svetkey LP, Bennett GG. The Effect of a Digital Behavioral Weight Loss Intervention on Adherence to the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern in Medically Vulnerable Primary Care Patients: Results from a Randomized Controlled Trial. J Acad Nutr Diet. 2019 Apr;119(4):574-584. doi: 10.1016/j.jand.2018.12.011. |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |