Heart Health and Nutrition for High Blood Pressure

(WEAVE HHNL Trial)

Overseen By Tassy Parker, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Pregnancy, Mental health, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a culturally sensitive health program can better manage high blood pressure in diverse communities. Participants will receive standard care, with some also joining a community health worker-led education program focused on healthy lifestyle choices, known as Heart Health and Nutrition for Life (HHNL). The study measures improvements in blood pressure, cholesterol, weight, blood sugar, and emotional well-being over a year. It targets individuals in Albuquerque's International District or South Valley with high blood pressure (130 or greater) who are already FNCH patients or willing to become one. This research respects cultural identity and seeks to make a real difference in community health. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and personal well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on standard hypertension care and self-monitoring, so it's best to check with the trial organizers for specific guidance.

What prior data suggests that the Heart Health and Nutrition for Life (HHNL) intervention is safe?

Research shows that changing one's diet can help lower high blood pressure. For instance, studies have found that certain diets, like the DASH diet, can reduce the systolic blood pressure by 6 to 11 points. This benefit has been observed in individuals with both high and normal blood pressure.

The Heart Health and Nutrition for Life (HHNL) program builds on these findings. It includes lessons on healthy eating, exercise, and stress management, all presented in a culturally respectful manner. Although specific data on the safety of the HHNL program is not yet available, similar diet programs are generally safe and free from major side effects. Participants can feel confident that focusing on lifestyle changes is typically safe and can improve health.

For those considering joining this trial, the program offers an opportunity to learn and adopt healthy habits that can help control blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Heart Health and Nutrition for Life (HHNL) treatment because it combines educational intervention with standard care, aiming to improve blood pressure management. Unlike traditional treatments that focus mainly on medication, HHNL emphasizes lifestyle changes through education, potentially empowering patients to manage their condition more effectively. This approach could lead to more sustainable long-term health benefits by addressing the root causes of high blood pressure, such as diet and lifestyle habits, rather than only treating symptoms. By integrating education with self-monitoring, HHNL offers a more comprehensive strategy for controlling blood pressure.

What evidence suggests that the Heart Health and Nutrition for Life (HHNL) intervention could be effective for high blood pressure?

Research shows that a heart-healthy diet can significantly lower blood pressure and reduce the risk of serious heart problems. Studies have found that individuals with good heart health are up to 76% less likely to develop high blood pressure. For those already experiencing high blood pressure, increasing the intake of fruits and vegetables can lead to noticeable improvements. Additionally, factors like education and neighborhood conditions can influence blood pressure management. This trial tests the Heart Health and Nutrition for Life (HHNL) program. Participants in the HHNL Educational Interventional Arm will receive an educational intervention promoting heart health through healthy eating, exercise, and stress management, while considering cultural and community needs. Meanwhile, the Comparator Arm will receive standard care with self blood pressure monitoring and the educational intervention in the second half of the study. ^{1 6 7 8 9}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for residents of Albuquerque's International District and South Valley with hypertension. It seeks participants from underserved communities, including Native American, African American, Hispanic/Latino, and Asian American groups. The study requires a commitment to a 12-month program involving standard care plus an educational component on heart health.

Inclusion Criteria

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

I can speak and read either English or Spanish.

Exclusion Criteria

Adults unable to consent, individuals not yet adults, and prisoners

Patients who self-report pregnancy

I am mentally and physically able to participate in all study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either the HHNL educational intervention or standard care with blood pressure self-monitoring for the first 6 months

6 months

Baseline, 3-4 months, and 6 months

Crossover Treatment

Participants switch roles; those who received HHNL now receive standard care and vice versa for the next 6 months

6 months

9 months and 12 months

Follow-up

Participants are monitored for changes in blood pressure, cholesterol, weight, blood sugar, and emotional well-being

12 months

Monthly self-monitoring logs

What Are the Treatments Tested in This Trial?

Interventions

• Heart Health and Nutrition for Life (HHNL)

Trial Overview The WEAVE NM trial tests the 'Heart Health and Nutrition for Life' (HHNL) program against standard hypertension care. Participants will learn about healthy eating, exercise, medication adherence, stress management while monitoring their blood pressure at home.

How Is the Trial Designed?

Group I: HHNL Educational Interventional Arm Experimental Treatment 2 Interventions

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.

Group II: Comparator Arm: Standard of Care and Self Blood Pressure Monitoring Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07074145

WEAVE NM: Heart Health and Nutrition for Life 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671479/

Association between “Life's Essential 8” cardiovascular health ... Compared to subjects with low CVH, participants with moderate and high CVH exhibited lower risks of 47% and 76%, respectively. After adjusting ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.22571

Impact of Social Determinants of Health on Hypertension ... Higher educational attainment, health insurance coverage, income, and favorable neighborhood characteristics were associated with lower hypertension prevalence.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/clc.24118

Effects of dietary patterns on the all‐cause mortality and ... Previous studies have showed that dietary patterns can significantly impact a HTN patient's health, with a noticeable effect on blood pressure ( ...

5. heart.org heart.org/en/health-topics/high-blood-pressure/changes-you-can-make-to-manage-high-blood-pressure/managing-blood-pressure-with-a-heart-healthy-diet

Managing Blood Pressure with a Heart-Healthy Diet Eating a heart-healthy diet is important to help manage your blood pressure and reduce your risk of heart attack, stroke and other health threats.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9152723/

Our Whole Lives for Hypertension and Cardiac Risk ... Outcome data collected at baseline and 8 weeks included the Mediterranean Diet Questionnaire, Hypertension Self-Care Profile Self-Efficacy Instrument, Blood ...

7. rarediseases.org rarediseases.org/nord-unveils-data-literacy-course/

NORD Unveils New, Free Data Literacy Course “With NORD's new data literacy course, patients and their families will be able to make smart decisions regarding participation in research, ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482514/

DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf They found that only the dietary intervention alone could decrease systolic blood pressure by about 6 to 11 mm Hg. This effect was seen both in hypertensive and ...

9. mdpi.com mdpi.com/2072-6643/16/5/629

Associations between Four Diet Quality Indexes and High ... Among the four selected a priori-defined DQIs, higher adherence to the HEI-2020 and the BHEI was associated with lower odds of having high BP, ...