WEAVE NM: Heart Health and Nutrition for Life

NCT07074145 | Recruiting

• 2 other identifiers: sub-OTA 6922-03-COVID-S014OT2HL158287
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Community Health Worker; Health Education; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Clinically measured blood pressure levels

  Baseline measurement and at about 3-, 6-, and 12- month timepoints

Secondary Outcomes (5)

• Diastolic Blood Pressure

  Measured at baseline and at about 3-, 6-, and 12-month timepoints.

• HbA1c

  Months 0, 3, 6 & 12

• BMI

  Months 0, 3, 6 & 12

• Lipid levels (total cholesterol, LDL, HDL, triglycerides)

  Months 0, 3, 6 & 12

• Psychological Distress

  Months 0, 3, 6 & 12

Other Outcomes (11)

• Consistency of BP self-monitoring

  Monthly: Months 1-12

• Adherence to anti-HTN medication

  Months 0, 3, 6 & 12

• Healthy eating

  Months 0, 3, 6 & 12

Study Arms (2)

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.

Behavioral: Heart Health and Nutrition for Life (HHNL); Behavioral: Self-Measured Blood Pressure

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.

Behavioral: Self-Measured Blood Pressure

Interventions

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.

HHNL Educational Interventional Arm

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.

Comparator Arm: Standard of Care and Self Blood Pressure Monitoring; HHNL Educational Interventional Arm

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently a FNCH patient or are willing and able to become a FNCH patient
• Current diagnosis of hypertension that was not onset due to pregnancy
• Able to speak and read English or Spanish
• Cognitively and physically able to independently understand and complete study procedures and provide written informed consent
• Self-report at least one systolic blood pressure reading of 130 or greater in the last six months OR show a systolic blood pressure reading of 130 or greater in baseline screening
• Live in and receive mail in Albuquerque, New Mexico

You may not qualify if:

• By design, adults unable to consent, individuals not yet adults, and prisoners will not be included in this study.
• Patients who self-report pregnancy will be automatically excluded from the study. While the investigators are not systematically screening for pregnancy throughout the study, if an individual self-reports pregnancy during the study, they will be withdrawn from study participation and offered the opportunity to re-join the study once no longer pregnant, if activities are still available, following general study procedures.
• Individuals who are not able to complete study procedures due to mental or behavioral health conditions, incarceration, or inability to physically bear an arm cuff will also be excluded from the study.

Sponsors & Collaborators

• University of New Mexico: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Westat: collaborator

Study Sites (1)

First Nations Community HealthSource

Albuquerque, New Mexico, 87108, United States

RECRUITING

Related Publications (19)

• 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.

  PMID: 35286164 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.

  PMID: 29395265 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.

  PMID: 28184154 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.

  PMID: 31130078 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.

  PMID: 29357392 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.

  PMID: 33180688 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.

  PMID: 30202926 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.

  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.

  PMID: 35503165 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.

  PMID: 30938688 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.

  PMID: 32564288 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.

  PMID: 32584755 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.

  PMID: 29860640 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.

  PMID: 36524696 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.

  PMID: 24396118 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.

  PMID: 33709805 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.

  PMID: 27633485 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.

  PMID: 30905430 BACKGROUND

MeSH Terms

Conditions

Hypertension; Health Education

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Tassy Parker, PhD, RN

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Linda Son-Stone, Ed D, MPH

  First Nations Community HealthSource

  PRINCIPAL INVESTIGATOR

• Lisa Cacari Stone, PhD, MS, MA

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blake Boursaw, MS

CONTACT

505-925-4377; bboursaw@salud.unm.edu

Tassy Parker, PhD, RN

CONTACT

505-272-4100; TaParker@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)