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Behavioral Intervention

PAL2 for High Blood Pressure (LEAPHTN Trial)

N/A

Recruiting

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low cardiovascular risk as defined by 2017 AHA/ACC HTN guidelines (no diabetes, no chronic kidney disease, no established ASCVD)

Not currently taking medications for HTN

Must not have

Chronic kidney disease or glomerular filtration rate <60 ml/min on screening laboratory testing

Chronic condition (e.g., cancer) with a potential life expectancy < 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a novel intervention, PAL2, to see if it is more effective than usual care in reducing blood pressure and preventing stage 1 hypertension in 500 black adults with elevated blood pressure. The intervention is being delivered in deprived neighborhoods by community health workers using a personalized, adaptable approach. The trial will also assess the reach, adoption, sustainability and cost-effectiveness of LEAP-HTN at 12 and 24 months.

Who is the study for?

This trial is for Black adults over 18 living in Detroit with low cardiovascular risk, meaning no diabetes, chronic kidney disease, or heart conditions. They should have slightly elevated blood pressure but not be taking hypertension medication. The study excludes those with serious health issues like heart failure or a life expectancy under 2 years.

What is being tested?

The LEAP-HTN study tests a personalized lifestyle intervention called PAL2 against usual care to reduce and prevent high blood pressure among Black adults at low cardiovascular risk. It uses mobile health units in communities for easy access to screening and follow-up.

What are the potential side effects?

Since the intervention involves lifestyle modifications rather than medications, typical drug side effects are not expected. However, participants may experience challenges adapting to new diet or exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at low risk for heart disease according to 2017 guidelines.

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I am not taking any medications for high blood pressure.

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I am at low risk for heart disease according to the AHA/ACC guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with a filtration rate under 60 ml/min.

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My doctor thinks I may have less than 2 years to live due to my condition.

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I have a heart condition like heart disease, heart failure, or stroke.

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I have diabetes or my HbA1c level is 6.5% or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systolic BP levels will be significantly lower (by ≥4 mm Hg) in participants randomized to the PAL2 (active) intervention versus usual care (control) over the first 12 months of the trial

Secondary study objectives

PAL2 (active) intervention will lower diastolic BP compared to usual care (control).

PAL2 (active) intervention will lower the incidence of stage-1 hypertension compared to the control group over 1 year

The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and 24 months, respectively.