WEAVE NM: Heart Health and Nutrition for Life

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity of New Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: HHNL Educational Interventional ArmExperimental treatment 2 interventions
Group B: Comparator Arm: Standard of Care and Self Blood Pressure MonitoringActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Systolic Blood Pressure

Clinically measured blood pressure levels

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

Secondary outcomes

1

Diastolic Blood Pressure

Clinically measured diastolic blood pressure

Time frame
Measured at baseline and at about 3-, 6-, and 12-month timepoints.
2

HbA1c

Diabetes Indicator

Time frame
Months 0, 3, 6 & 12
3

BMI

Body Mass Index

Time frame
Months 0, 3, 6 & 12
4

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

Cholesterol

Time frame
Months 0, 3, 6 & 12

Other outcomes

1

Consistency of BP self-monitoring

Monthly self-measured BP logs

Time frame
Monthly: Months 1-12
2

Adherence to anti-HTN medication

H-SCALE subscale

Time frame
Months 0, 3, 6 & 12
3

Healthy eating

H-SCALE subscale

Time frame
Months 0, 3, 6 & 12
4

Physical Activity Engagement

H-SCALE subscale

Time frame
Months 0, 3, 6 & 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of New Mexico

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Westat

Collaborator