528 Participants Needed

Lifestyle Intervention for High Blood Pressure

(EPIPHANY Trial)

SH
AC
Overseen ByAndrea Cherrington, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.23678

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.1391011

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.

Eligibility Criteria

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
See 2 more

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Health Education & Peer CoachingExperimental Treatment3 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 OnlyActive Control2 Interventions
Participants will have access to online health education materials but will not receive individualized peer support

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Findings from Research

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.
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.
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.
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]

References

A randomized trial of peer-delivered self-management support for hypertension. [2021]
Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. [2010]
The Impact of Peer Support Program on Adherence to the Treatment Regimen in Patients with Hypertension: A Randomized Clinical Trial Study. [2022]
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]
Peer coaching to improve diabetes self-management: which patients benefit most? [2022]
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]
Understanding women veterans' preferences for peer support interventions to promote heart healthy behaviors: A qualitative study. [2020]
A community organization-peer facilitated senior citizen health promotion program. [2010]
Role of community programs in controlling blood pressure. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale. [2022]
11.United Statespubmed.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]
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