HypertensionWEAVE HHNLNCT07074145
WEAVE NM: Heart Health and Nutrition for Life
A study testing Heart Health and Nutrition for Life (HHNL) and Self-Measured Blood Pressure in people with Hypertension, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Heart Health and Nutrition for Life (HHNL) and Self-Measured Blood Pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 30 Nov 2027
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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screening for pregnancy throughout the study, if an individual self-reports pregnancy during the study, they will be withdrawn from study participation and offered the opportunity to re-join the study once no longer pregnant, if activities are still available, following general study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.
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, 1 recruiting
- Recruiting
First Nations Community HealthSource
Albuquerque, New Mexico, 87108
Nicole Tsosie, 505-705-3349, Nichole.Tsosie@fnch.org
About this study
Official title: WEAVE NM Project: Heart Health and Nutrition for Life (HHNL)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Heart Health and Nutrition for Life (HHNL), Self-Measured Blood Pressure
- Keywords
- Hypertension, Community Health Worker, Health Education, Blood Pressure
- Medical subject headings
- Hypertension, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health and Nutrition for Life (HHNL)Behavioural
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.
Self-Measured Blood PressureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Measured Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Clinically measured blood pressure levels
Measured: Baseline measurement and at about 3-, 6-, and 12- month timepoints
Secondary outcomes (5)
Diastolic Blood Pressure
Clinically measured diastolic blood pressure
Measured: Measured at baseline and at about 3-, 6-, and 12-month timepoints.
HbA1c
Diabetes Indicator
Measured: Months 0, 3, 6 & 12
BMI
Body Mass Index
Measured: Months 0, 3, 6 & 12
Lipid levels (total cholesterol, LDL, HDL, triglycerides)
Cholesterol
Measured: Months 0, 3, 6 & 12
Psychological Distress
Kessler Psych Distress scale (K10)
Measured: Months 0, 3, 6 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start21 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Westat
- Responsible party
- Sponsor
- Investigators
- Tassy Parker, PhD, RN, Principal investigator, University of New MexicoLinda Son-Stone, Ed D, MPH, Principal investigator, First Nations Community HealthSourceLisa Cacari Stone, PhD, MS, MA, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074145
- Sponsor's protocol ID
- sub-OTA 6922-03-COVID-S014
- Other IDs
- OT2HL158287
- Acronym
- WEAVE HHNL
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35286164Ma 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.
PubMed 29395265Khorsandi 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.
PubMed 28184154Warren-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.
PubMed 31130078Carey 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.
PubMed 29357392Rink 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.
PubMed 33180688Kwon 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.
PubMed 30202926U.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
Healthy for Life. www.heart.org. (n.d.). https://www.heart.org/en/healthy-living/companycollaboration/healthy-for-life.
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.
PubMed 35503165Schroeder 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.
PubMed 30938688Meador 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.
PubMed 32564288Stupplebeen 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.
PubMed 32584755Blue 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.
PubMed 29860640Parker 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.
PubMed 36524696
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEAVE NM Project: Heart Health and Nutrition for Life (HHNL)
- ClinicalTrials.gov ID
- NCT07074145
- Acronym / sponsor ID
- WEAVE HHNL / sub-OTA 6922-03-COVID-S014
- Conditions
- Hypertension
- Keywords
- Hypertension, Community Health Worker, Health Education, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Westat
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 Jul 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HHNL Educational Interventional Arm | Experimental | Behavioral: Heart Health and Nutrition for Life (HHNL), Behavioral: Self-Measured Blood PressureArm 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 | Behavioral: Self-Measured Blood PressureArm 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Heart Health and Nutrition for Life (HHNL)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. | Behavioural | HHNL Educational Interventional Arm |
| Self-Measured Blood PressureSelf-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. | Behavioural | Comparator Arm: Standard of Care and Self Blood Pressure Monitoring, HHNL Educational Interventional Arm |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline measurement and at about 3-, 6-, and 12- month timepoints
Clinically measured blood pressure levels
5 secondary outcomes
Diastolic Blood Pressure
Time frame: Measured at baseline and at about 3-, 6-, and 12-month timepoints.
HbA1c
Time frame: Months 0, 3, 6 & 12
BMI
Time frame: Months 0, 3, 6 & 12
Lipid levels (total cholesterol, LDL, HDL, triglycerides)
Time frame: Months 0, 3, 6 & 12
Psychological Distress
Time frame: Months 0, 3, 6 & 12
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 30 Jul 2026.
- Background: PubMed 35286164Kandzari 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.
- Background: PubMed 29395265Ma 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.
- Background: PubMed 28184154Khorsandi 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.
- Background: PubMed 31130078Warren-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.
- Background: PubMed 29357392Carey 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.
- Background: PubMed 33180688Rink 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.
- Background: PubMed 30202926Kwon 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.
- BackgroundU.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
- BackgroundHealthy for Life. www.heart.org. (n.d.). https://www.heart.org/en/healthy-living/companycollaboration/healthy-for-life.
- Background: PubMed 35503165Moore 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.
- Background: PubMed 30938688Schroeder 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.
- Background: PubMed 32564288Meador 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Tassy Parker, PhD, RN principal investigator
University of New Mexico
Linda Son-Stone, Ed D, MPH principal investigator
First Nations Community HealthSource
Lisa Cacari Stone, PhD, MS, MA principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Health and Nutrition for Life (HHNL) and Self-Measured Blood Pressure in people with Hypertension, run by University of New Mexico 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 Blake Boursaw, MS (505-925-4377, bboursaw@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline measurement and at about 3-, 6-, and 12- month timepoints). 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 NCT07074145, which also lists 19 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 30 Jul 2026.