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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Nutrition Program for Hypertension?

Research shows that community health workers (CHWs) are effective in helping people stick to their medication and low-salt diets, which are important for controlling high blood pressure. Additionally, programs that educate nurses on diet for hypertension have led to better blood pressure control in patients. ^{1 2 3 4 5}

Is the Nutrition Program for Hypertension safe for humans?

The research articles reviewed do not provide specific safety data for the Nutrition Program for Hypertension or similar interventions. However, community health worker (CHW) programs, which include nutrition education, have been used in various settings without reported safety concerns, suggesting they are generally safe for human participants. ^{5 6 7 8 9}

How is the Nutrition-enhanced CHW treatment for hypertension different from other treatments?

The Nutrition-enhanced CHW treatment is unique because it combines nutritional counseling with community health worker support to improve dietary habits and blood pressure control, focusing on education and cultural relevance, unlike standard drug treatments. ^{1 4 5 10 11}

What is the purpose of this trial?

The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months.

Research Team

Anne N Thorndike, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. India 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. [2022]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Influences of Parenting Education on Development of Obesity Among Young Children. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Effect of Performance Feedback on Community Health Workers' Motivation and Performance in Madhya Pradesh, India: A Randomized Controlled Trial. [2019]

8. France pubmed.ncbi.nlm.nih.gov

[Training of community health aides in the subject of nutrition]. [2011]

9. United States 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. [2021]

10. United States 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. [2021]

11. United States 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. [2020]