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WEAVE NM: Heart Health and Nutrition for Life

WEAVE NM Project: Heart Health and Nutrition for Life (HHNL)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074145
Acronym
WEAVE HHNL
Enrollment
240
Registered
2025-07-20
Start date
2025-02-21
Completion date
2027-11-30
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Community Health Worker, Health Education, Blood Pressure

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.

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.

Interventions

BEHAVIORALHeart 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.

BEHAVIORALSelf-Measured Blood Pressure

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.

Sponsors

University of New Mexico
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Westat
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood PressureBaseline measurement and at about 3-, 6-, and 12- month timepointsClinically measured blood pressure levels

Secondary

MeasureTime frameDescription
Diastolic Blood PressureMeasured at baseline and at about 3-, 6-, and 12-month timepoints.Clinically measured diastolic blood pressure
HbA1cMonths 0, 3, 6 & 12Diabetes Indicator
BMIMonths 0, 3, 6 & 12Body Mass Index
Lipid levels (total cholesterol, LDL, HDL, triglycerides)Months 0, 3, 6 & 12Cholesterol
Psychological DistressMonths 0, 3, 6 & 12Kessler Psych Distress scale (K10)

Countries

United States

Contacts

CONTACTBlake Boursaw, MS
bboursaw@salud.unm.edu505-925-4377
CONTACTTassy Parker, PhD, RN
TaParker@salud.unm.edu505-272-4100
PRINCIPAL_INVESTIGATORTassy Parker, PhD, RN

University of New Mexico

PRINCIPAL_INVESTIGATORLinda Son-Stone, Ed D, MPH

First Nations Community HealthSource

PRINCIPAL_INVESTIGATORLisa Cacari Stone, PhD, MS, MA

University of New Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026