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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent high blood pressure among Black adults in rural Alabama. Researchers seek to determine if support from church communities and online resources can help lower blood pressure. Participants will receive either health education and online resources or additional phone support from a health coach, providing community-level peer support. The trial seeks Black adults with blood pressure slightly above normal but not high enough to require medication. As an unphased trial, this study offers a unique opportunity to contribute to innovative community-based health solutions.

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

Research has shown that support from peers and health coaches can safely and effectively manage high blood pressure. One study found these methods improved mental health without negative effects. Another study discovered that community programs like these help people feel more in control and enhance their self-care habits.

These findings suggest that peer coaches and community support might not only be safe but also offer additional benefits beyond managing high blood pressure. While these methods don't involve medication, they focus on lifestyle changes, which are generally low-risk. This makes them a promising option for those seeking to lower their blood pressure safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for high blood pressure because they offer a unique approach that focuses on community and individual-level support rather than just medication. Unlike standard treatments that often rely on drugs like ACE inhibitors or beta-blockers, these interventions include access to online health education and personalized peer coaching. This method emphasizes the power of community health workers who can provide tailored support, potentially leading to more sustainable lifestyle changes and better long-term blood pressure management. By involving peer support, these interventions aim to empower participants to take control of their health in a more holistic way.

What evidence suggests that this trial's interventions could be effective for high blood pressure?

Research shows that support from community members can help lower blood pressure. In this trial, participants in the "Health Education & Peer Coaching" arm will receive online health education materials and support from a community health worker through peer coaching. Studies have found that peer coaching is more effective than regular care for managing high blood pressure, especially for underserved groups. One study found that peer coaching lowered the systolic blood pressure by 5 points in people under 60. Participants in the "Health Education Only" arm will have access to online health education materials but will not receive individualized peer support. Lifestyle changes, such as exercising more and eating more fruits and vegetables, can also help reduce blood pressure. These findings suggest that peer support and health education can effectively manage high blood pressure in communities. ^{2 6 7 8 9}

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

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487347/

Assessing Community-Based interventions effectiveness ... Effective lifestyle changes to reduce blood pressure include weight loss, reduced sodium intake, increased physical activity, limited alcohol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9670931/

a cluster randomised controlled pragmatic trial Our results indicated that a community-based intervention led by women's SHG members was effective in reducing BP and improving hypertension ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805604

Effect of a Peer Health Coaching Intervention on Clinical ... We found that the peer health coaching intervention did not improve blood pressure levels but led to improvements in mental HRQOL, as ...

4. news.weill.cornell.edu news.weill.cornell.edu/news/2024/03/peer-coaching-helps-marginalized-individuals-lower-blood-pressure

Peer Coaching Helps Marginalized Individuals Lower ... Peer coaching is more effective than traditional clinical care in controlling high blood pressure, according to a new study led by investigators at Weill ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2816426

Practice Facilitation and Peer Coaching for Uncontrolled ... Peer coaching significantly lowered systolic blood pressure in people younger than 60 years by 5 mm Hg. Meaning Peer coaching can help younger ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10949149/

Practice Facilitation and Peer Coaching for Uncontrolled ... Does coaching by a trained peer or practice facilitation improve persistently uncontrolled high blood pressure in rural Black participants?

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08743-8

Effectiveness of community-based intervention using PATCH ... This study aimed to determine the effectiveness of a community-based intervention using the PATCH on disease perception, empowerment, self-care behaviors, and ...

8. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000232

Implementation Strategies to Improve Blood Pressure ... This scientific statement provides information on the implementation strategies to optimize hypertension management and to improve BP control among adults in ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8645688/

Scaling a Community-Wide Campaign Intervention to Manage ... Based on the RE-AIM Framework, the intervention “reached” its intended population of low-income Latinos, demonstrated “effectiveness” in improving hypertension ...