Nutrition Program for Hypertension

(HeartWell Trial)

Overseen By Anne N Thorndike, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Declines participation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a new nutrition program can assist people with high blood pressure (hypertension) who also face challenges in accessing healthy food. Participants will receive guidance from community health workers, focusing on nutrition and support for managing blood pressure through education and self-monitoring. The trial aims to determine if adding a nutrition component (Nutrition-enhanced Community Health Worker Intervention) improves blood pressure management compared to basic support alone (Basic Community Health Worker Intervention). Suitable candidates have uncontrolled high blood pressure, are patients at certain clinics, and belong to a minoritized racial/ethnic group or have a low income. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance community health support systems.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on adding a nutrition program to existing care, which includes coaching about sticking to your medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that programs involving community health workers (CHWs), such as the Nutrition-enhanced CHW intervention, are generally safe and well-received. Studies have found that CHWs can help people better manage their blood pressure, indicating that this method is both effective and safe.

No specific negative effects have been reported for CHW programs, which focus on teaching and support rather than medication. These programs aim to improve knowledge and skills about diet, especially for those with limited resources. As the program is primarily educational, it is considered low-risk.

Overall, evidence supports the safety of the CHW approach used in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Nutrition-enhanced CHW intervention" for hypertension because it goes beyond typical medication and lifestyle advice by integrating a tailored nutrition education component specifically designed for food-insecure populations. Unlike standard treatments that primarily focus on medication adherence and blood pressure monitoring, this approach aims to empower patients with the knowledge and skills needed to sustain a healthful diet, addressing a critical gap in hypertension management. By providing a practical nutrition curriculum that is customized to the resources and preferences of participants, this intervention has the potential to improve dietary habits and, in turn, enhance blood pressure control in a more holistic and sustainable way.

What evidence suggests that this trial's interventions could be effective for hypertension?

Research has shown that community health worker (CHW) programs can help lower blood pressure in people with hypertension. One study from rural South India demonstrated that a CHW-led program significantly improved blood pressure control among participants. These programs often focus on teaching and encouraging healthy habits, which are crucial for managing high blood pressure. In this trial, participants will receive either a Basic CHW intervention or a Nutrition-enhanced CHW intervention. Adding a nutrition component to the CHW program addresses gaps in knowledge and dietary challenges faced by participants. This approach has successfully improved health, especially when tailored to meet the specific needs of a community. ^{1 2 3 6 7}

Who Is on the Research Team?

Anne N Thorndike, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 21 with uncontrolled high blood pressure, who are patients at one of the five participating clinics. It's aimed at those from minority racial/ethnic backgrounds or low-income individuals and requires English or Spanish speakers.

Inclusion Criteria

Eligible to participate in the Massachusetts General Hospital CHW hypertension program (age 21 years or older, uncontrolled hypertension, patient at one of 5 participating primary care clinics; either identifies as a minoritized race/ethnicity or is low-income); speaks English or Spanish

Exclusion Criteria

I have chosen not to participate in the CHW hypertension program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-month Nutrition-enhanced CHW intervention, including education on nutrition label reading, grocery shopping, meal-planning, and healthy cooking

16 weeks

Regular visits with CHWs for education and monitoring

Follow-up

Participants are monitored for changes in blood pressure and diet quality after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Basic CHW
• Nutrition-enhanced CHW

Trial Overview The study tests a nutrition-focused community health worker (CHW) intervention against a basic CHW program that includes hypertension education and support. Participants will be randomly assigned to either group for about four months.

How Is the Trial Designed?

Group I: Nutrition-enhanced CHW intervention Experimental Treatment 1 Intervention

This intervention integrates a nutrition component into the Basic CHW hypertension intervention to address gaps in patients' knowledge, skills, and resources for consuming and sustaining a healthful diet. CHWs will administer a 4-part nutrition curriculum that is tailored to the needs and preferences of a food-insecure population with limited resources. The nutrition education materials provided to participants will include a booklet of nutrition information that will serve as the primary educational resource for CHW use with participants.

Group II: Basic CHW intervention Active Control 1 Intervention

The CHW provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring. All participants are provided home BP cuffs and remote monitoring free of charge.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Community health workers (CHWs) significantly improve blood pressure control in patients, as shown in seven out of eight randomized controlled trials (RCTs) reviewed, particularly among underserved urban African American populations.

CHWs also enhance self-management behaviors related to hypertension, such as medication adherence and appointment attendance, indicating their valuable role in multidisciplinary healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. Brownstein, JN., Chowdhury, FM., Norris, SL., et al.[2022]

Community health worker (CHW) interventions in low- and middle-income countries have shown positive effects on reducing blood pressure, improving treatment adherence, and lowering cardiovascular disease risk among hypertensive patients and healthy individuals, based on a review of 14 studies.

The review highlighted that while CHW interventions were effective, the diversity in intervention types and outcomes prevented a meta-analysis, indicating a need for further research to assess the overall impact and cost-effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. Mbuthia, GW., Magutah, K., Pellowski, J.[2023]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

Structured health education for community health workers significantly improved hypertensive patients' knowledge about hypertension, leading to better medication adherence, which increased from 20% to 70%.

The intervention also resulted in a notable improvement in low salt diet compliance among patients, rising from 39% to 85%, while the control group showed no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. Lukitasari, M., Nugroho, DA., Rohman, MS., et al.[2022]

A community health worker-led intervention significantly improved blood pressure control among participants in rural South India, with control rates increasing from 49.5% to 69.7% in the intervention group compared to a smaller increase from 52.2% to 61.7% in the usual care group.

The intervention also resulted in greater reductions in both systolic and diastolic blood pressure, indicating its efficacy in managing hypertension, while maintaining similar levels of medication use between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial. Gamage, DG., Riddell, MA., Joshi, R., et al.[2020]

A randomized controlled trial involving 177 high-risk infants showed that an educational intervention by community health workers did not significantly prevent obesity by age 3, with 24% of children classified as obese at the final visit.

However, breastfed infants in the intervention group experienced significantly less time spent obese (11.9%) compared to formula-fed infants in the control group (29.8%), highlighting the importance of breastfeeding in obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of Parenting Education on Development of Obesity Among Young Children. McCormick, DP., Niebuhr, B., Reyna, L., et al.[2023]

Providing performance feedback to community health workers (CHWs) significantly improved their counseling duration, with a large effect size (Glass's delta=0.97) during the initial 6 weeks, and this improvement was sustained even after the intervention ended (Glass's delta=1.69).

While the feedback did not lead to significant improvements in case activity or form submissions, the supportive supervision aspect of the calls helped maintain CHW motivation, indicating that regular feedback can enhance overall performance in health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Performance Feedback on Community Health Workers' Motivation and Performance in Madhya Pradesh, India: A Randomized Controlled Trial. Kaphle, S., Matheke-Fischer, M., Lesh, N.[2019]

Training community health workers (C.H.W.) is a crucial strategy for addressing nutritional diseases, as it enhances their ability to support local communities in improving nutritional status.

Effective training plans should include an intervention model and a step-by-step approach, emphasizing the importance of communication and problem-solving skills for C.H.W. to successfully engage with health personnel and community members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training of community health aides in the subject of nutrition]. Fournier, G., Girard, J.[2011]

A community health worker (CHW)-based intervention significantly improved dietary variety among older adults in Japan, with an increase of 1.60 points in dietary variety scores during the initial 2-month period.

The positive effects of the intervention persisted for at least 2 months after completion, suggesting that CHW-led programs can effectively promote healthy eating habits and support healthy aging in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Community Health Worker-Based Intervention in Improving Dietary Habits Among Community-Dwelling Older People: A Controlled, Crossover Trial in Japan. Murayama, H., Taguchi, A., Spencer, MS., et al.[2021]

The Hypertension Diet Education Program successfully trained practical nurses to provide culturally relevant nutritional counseling, leading to significant improvements in their knowledge and skills.

Among the patients counseled, 63% achieved controlled blood pressure readings within eight months, demonstrating the program's effectiveness in managing hypertension through dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hypertension diet education program for public health nurses. Kostas, G.[2009]

The pilot study demonstrated that a 4-month community health worker (CHW) intervention significantly reduced blood pressure and improved weight and body mass index among Filipino immigrants, indicating its efficacy in managing hypertension.

While the intervention did not significantly improve medication adherence or appointment keeping, it successfully enhanced participants' knowledge about cardiovascular disease and their self-efficacy regarding diet and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community health worker intervention to improve management of hypertension among Filipino Americans in New York and New Jersey: a pilot study. Ursua, RA., Aguilar, DE., Wyatt, LC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11462560/

Patient and Community Health Worker (CHW) Perspectives ... This study identified culture, knowledge gaps, and budget constraints as factors influencing diet among patients with hypertension and FI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8977767/

Approaches and outcomes of community health worker's ... The CHW interventions were mainly community-based and focused on behaviour change for promoting BP control among hypertensive patients as well as healthy ...

3. withpower.com withpower.com/trial/phase-2-and-3-hypertension-7-2024-3a105

Nutrition Program for Hypertension (HeartWell Trial) A community health worker-led intervention significantly improved blood pressure control among participants in rural South India, with control rates ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06230835

Community Health Worker Led Hypertension Prevention ... There are proven evidence-based interventions that have been recommended for the prevention and control of HTN including weight loss; healthy ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.009900

Community Health Workers as Key Allies in the Global ... A mere 1 in 5 adults worldwide have their high blood pressure (BP) successfully treated to below 140/90 mm Hg. While the most dismal statistics ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/4/e053455

Approaches and outcomes of community health worker's ... Summarised outcomes of individual studies showed CHW enhanced the control and management of hypertension. Further studies are needed to indicate the impact and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4785041/

Effects of Community-Based Health Worker Interventions to ... Eight studies examined CBHW interventions for better blood pressure control. Significant improvements in blood pressure control were seen in 4 studies.