Lifestyle Intervention for High Blood Pressure

(EPIPHANY Trial)

Overseen By Andrea Cherrington, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Antihypertensives

Disqualifiers: Hypertension, Cardiovascular disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to test an intervention to prevent high blood pressure among rural, Black adults living in Alabama. Black adults in this region have one of the highest rates of high blood pressure in the US. Eating fruits and vegetables and exercising daily lowers the chance of getting high blood pressure. Many problems get in the way of eating a healthy diet and exercising like a lack of grocery stores with fresh foods, few gyms, little money, lack of transportation, and limited support for keeping healthy habits. One place where many Black adults in rural Alabama meet weekly and feel supported is their church. The investigators will connect with 30 churches in rural Alabama. The investigators plan to hold health fairs to find 12 Black adults from each church with blood pressure that is higher than normal but not high enough to need blood pressure lowering medications. The investigators will randomly select 15 churches to get group health education and tablets to access online cooking shows and exercise classes. Adults in the other 15 churches will get support from a health coach over the telephone to help set and meet diet and physical activity goals as well as the group health education and tablets to access online cooking shows and exercise classes. In this study, the investigators will ask church members to sign up to be a health coach. These 15 churches will also get money to help bring healthy foods and/or physical activity opportunities to their communities. The investigative team will train 2 to 3 of their church members to learn how to coach others to eat more healthy food and be more physically active. This study answers two questions. 1) Will this intervention designed to reduce barriers to a healthy lifestyle lower blood pressure among rural, Black adults? 2) Can churches and participants complete the whole two-year study, and can the intervention be used in other communities in a cost-effective way to improve blood pressure? This project will add to the health equity mission of the American Heart Association by finding out if an intervention using health coaches lowers blood pressure among rural Black adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking blood pressure-lowering medications.

Is the lifestyle intervention for high blood pressure safe for humans?

The studies on community-based education and peer support programs for managing high blood pressure suggest that these interventions are generally safe for humans, as they focus on lifestyle changes like exercise, diet, and peer support without involving risky procedures or medications. ^{1 2 3 4 5}

How is the Community-Level Peer Support treatment for high blood pressure different from other treatments?

This treatment is unique because it uses community-based peer support and health education to help people manage their high blood pressure, focusing on lifestyle changes like healthy eating and physical activity, rather than relying solely on medication. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Community-Level Peer Support, Community-Based Intervention, Peer Coaching, Health Coaching, Health Education, Cancer Health Education, Individual-Level Peer Support, Peer Coaching, Individual-Level Peer Support, Health Coaching for high blood pressure?

Research shows that peer support programs can help people stick to their treatment plans for high blood pressure, and peer coaching has been effective in helping patients manage diabetes, suggesting it could also help with high blood pressure. ^{3 4 8 10 11}

Are You a Good Fit for This Trial?

This trial is for Black/African American adults living in rural Alabama with slightly elevated blood pressure, but not high enough to require medication. Participants should be under 65 years old without a history of heart disease, diabetes, or kidney issues and must speak English. They can't join if they're pregnant, planning to move soon, or don't have a phone.

Inclusion Criteria

Your blood pressure is between 120/80 and 139/89.

Your average blood pressure is between 120/80 and 139/89.

Self-identify as Black/African American

Exclusion Criteria

Known pregnancy

You plan to move to a different area within the next 18 months.

I have had high blood pressure not related to pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive group health education and access to online cooking shows and exercise classes. Some participants receive additional support from a health coach.

24 months

Regular virtual check-ins and community events

Follow-up

Participants are monitored for changes in blood pressure, diet, physical activity, alcohol use, and smoking habits.

6 months

Periodic assessments at 6, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Community-Level Peer Support
• Health Education
• Individual-Level Peer Support

Trial Overview The study tests whether health education and peer support interventions delivered through churches can lower blood pressure among rural Black adults. Half the churches offer group education and online resources; the other half adds personalized telephone coaching from trained church members.

How Is the Trial Designed?

Group I: Health Education & Peer Coaching Experimental Treatment 3 Interventions

Participants will have access to online health education materials and will also be matched with a community health worker who will offer support through peer coaching

Group II: Health Education Only Active Control 2 Interventions

Participants will have access to online health education materials but will not receive individualized peer support

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A peer-led hypertension self-management intervention resulted in a significant overall decrease in systolic blood pressure (SBP) by 4.4 mm Hg after 12 months, indicating its potential effectiveness in managing hypertension among veterans.

However, the peer-led approach was not more effective than professionally delivered seminars, as both methods achieved similar reductions in SBP, suggesting that professional guidance may not be necessary for effective hypertension management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of peer-delivered self-management support for hypertension. Whittle, J., Schapira, MM., Fletcher, KE., et al.[2021]

A peer support program involving Veterans of Foreign Wars posts in Wisconsin effectively trained 27 peer leaders over 18 months to promote self-management of hypertension, with 93% of participating posts remaining active throughout the study.

The program resulted in peer leaders gaining health knowledge and confidence, which enhanced health support among veterans, highlighting the potential of community-based initiatives in improving chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. Hayes, A., Morzinski, J., Ertl, K., et al.[2010]

A clinical trial involving 64 patients with hypertension demonstrated that a peer support program significantly improved adherence to treatment regimens, including medication, diet, and activity, compared to a control group.

The positive effects of the peer support program were evident immediately after the intervention and persisted one month later, indicating its potential as an effective strategy for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Peer Support Program on Adherence to the Treatment Regimen in Patients with Hypertension: A Randomized Clinical Trial Study. Haidari, A., Moeini, M., Khosravi, A.[2022]

This study aims to evaluate a peer support intervention for improving hypertension control among 400 Veterans with poorly managed hypertension and additional cardiovascular risks, using a home-based approach with peer health coaches.

The trial will assess the effectiveness of this intervention by measuring changes in systolic blood pressure and cardiovascular disease risk, potentially providing valuable insights for community-based prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. Nelson, K., Fennell, T., Gray, KE., et al.[2019]

Peer health coaching significantly lowers hemoglobin A1c (A1c) levels in patients with diabetes who have low self-management and medication adherence, indicating its effectiveness in high-risk groups.

In contrast, patients with high self-management and adherence showed similar improvements in A1c regardless of whether they received coaching or usual care, suggesting that coaching is particularly beneficial for those struggling with diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer coaching to improve diabetes self-management: which patients benefit most? Moskowitz, D., Thom, DH., Hessler, D., et al.[2022]

A community-based education and peer support program led by women's self-help group members significantly reduced mean systolic blood pressure (SBP) by 6.26 mm Hg over 6 months in urban slums of Kochi, compared to a 2.16 mm Hg reduction in the control group.

The study involved 1952 participants and demonstrated that this intervention was more effective than standard care, highlighting the potential of community engagement in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community-based education and peer support led by women's self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial. P Suseela, R., Ambika, RB., Mohandas, S., et al.[2023]

Peer support can effectively enhance heart-healthy behaviors among women veterans at risk for cardiovascular disease, highlighting the importance of communal identity in health interventions.

Interviews with 25 women veterans revealed key factors for successful peer support, including shared goals, trust, compatibility in engagement levels, positivity, and accountability, suggesting that tailored peer matching and initial in-person interactions are crucial for building effective support relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. Goldstein, KM., Zullig, LL., Oddone, EZ., et al.[2020]

A community-based intervention program for hypertension involving 17 senior participants led to significant improvements in health, with 14 individuals losing a total of 89 pounds and 6 participants achieving acceptable blood pressure levels.

The program emphasized self-responsibility for health through regular exercise, dietary instruction, and peer support, demonstrating that grassroots community efforts can effectively manage hypertension in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community organization-peer facilitated senior citizen health promotion program. Sutherland, M., Cowart, M., Heck, C.[2010]

Community-based programs have been effective in raising awareness and promoting healthier behaviors to control high blood pressure, emphasizing partnerships and resident involvement in screening and education.

Utilizing trained community health workers to deliver culturally sensitive education on heart health has been shown to enhance the effectiveness of these programs, potentially leading to better blood pressure management in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. Fulwood, R., Guyton-Krishnan, J., Wallace, M., et al.[2019]

The PREMIER trial tested two lifestyle interventions aimed at improving blood pressure control through established guidelines, including weight loss, reduced sodium intake, and increased physical activity, compared to standard advice.

Both interventions emphasized behavioral self-management and personalized feedback, highlighting their potential effectiveness in preventing chronic diseases like hypertension, especially in high-risk minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale. Funk, KL., Elmer, PJ., Stevens, VJ., et al.[2022]

Community-led health care interventions can effectively address cardiovascular disease risk factors in deprived areas, emphasizing the importance of engaging community members in the design and implementation process.

Qualitative feedback from 47 participants revealed key themes for intervention design, including the need for suitable management, logistical planning, and consideration of sociocultural factors, leading to recommendations for a bottom-up approach and the recruitment of skilled local volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pre-Implementation Phase of a Project Seeking to Deliver a Community-Based CVD Prevention Intervention (SPICES-Sussex): A Qualitative Study Exploring Views and Experience Relating to Intervention Development. Grice-Jackson, T., Rogers, I., Ford, E., et al.[2023]

Citations

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

A randomized trial of peer-delivered self-management support for hypertension. [2021]

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

Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. [2010]

3. India pubmed.ncbi.nlm.nih.gov

The Impact of Peer Support Program on Adherence to the Treatment Regimen in Patients with Hypertension: A Randomized Clinical Trial Study. [2022]

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

Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. [2019]

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

Peer coaching to improve diabetes self-management: which patients benefit most? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a community-based education and peer support led by women's self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial. [2023]

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

Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. [2020]

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

A community organization-peer facilitated senior citizen health promotion program. [2010]

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

Role of community programs in controlling blood pressure. [2019]

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

PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale. [2022]

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

The Pre-Implementation Phase of a Project Seeking to Deliver a Community-Based CVD Prevention Intervention (SPICES-Sussex): A Qualitative Study Exploring Views and Experience Relating to Intervention Development. [2023]