Recruiting

HHNL

Sponsor:

University of New Mexico

Code:

NCT07074145

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Heart Health and Nutrition for Life (HHNL)

Self-Measured Blood Pressure

Study Details

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

Study ID

NCT07074145

Start date

Feb 21, 2025

Status verified date

Jul, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: HHNL Educational Interventional Arm

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.

active comparator: Comparator Arm: Standard of Care and Self Blood Pressure Monitoring

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.

Interventions

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.

Self-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.

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: Baseline measurement and at about 3-, 6-, and 12- month timepoints ]

Central Contacts and Locations

Central contacts

Blake Boursaw, MS

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

Tassy Parker, PhD, RN

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

Locations

First Nations Community HealthSource

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Nicole Tsosie

505-705-3349Nichole.Tsosie@fnch.org

More Information

Sponsor

University of New Mexico

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Hypertension
  • Community Health Worker
  • Health Education
  • Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-07-30.