An interventional study of Heart Health and Nutrition for Life (HHNL) and Self-Measured Blood Pressure in Hypertension, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of New Mexico · Not applicable, Interventional, and Prevention
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 240 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Exclusion Criteria:
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
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
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 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.
Systolic Blood Pressure
Clinically measured blood pressure levels
Time frame: Baseline measurement and at about 3-, 6-, and 12- month timepoints
Diastolic Blood Pressure
Clinically measured diastolic blood pressure
Time frame: Measured at baseline and at about 3-, 6-, and 12-month timepoints.
HbA1c
Diabetes Indicator
Time frame: Months 0, 3, 6 & 12
BMI
Body Mass Index
Time frame: Months 0, 3, 6 & 12
Lipid levels (total cholesterol, LDL, HDL, triglycerides)
Cholesterol
Time frame: Months 0, 3, 6 & 12
Psychological Distress
Kessler Psych Distress scale (K10)
Time frame: Months 0, 3, 6 & 12
Consistency of BP self-monitoring
Monthly self-measured BP logs
Time frame: Monthly: Months 1-12
Adherence to anti-HTN medication
H-SCALE subscale
Time frame: Months 0, 3, 6 & 12
Healthy eating
H-SCALE subscale
Time frame: Months 0, 3, 6 & 12
Physical Activity Engagement
H-SCALE subscale
Time frame: Months 0, 3, 6 & 12
Weight management
H-SCALE subscale
Time frame: Months 0, 3, 6 & 12
Avoiding alcohol and tobacco
H-SCALE subscale
Time frame: Months 0, 3, 6 & 12
Self-efficacy
Health Belief Model adapted subscale
Time frame: Months 0, 3, 6 & 12
Perceived susceptibility
Health Belief Model adapted subscale
Time frame: Months 0, 3, 6 & 12
Perceived severity
Health Belief Model adapted subscale
Time frame: Months 0, 3, 6 & 12
Perceived benefits
Health Belief Model adapted subscale
Time frame: Months 0, 3, 6 & 12
Community pride
Adapted single-item behavior change influence outcome
Time frame: Months 0, 3, 6 & 12
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
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