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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

LEAPHTN Trial 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.Check my eligibility
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.See study design
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.

LEAPHTN Trial 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.

LEAPHTN Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

LEAPHTN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Randomized selection of recruited participants that will receive intervention
Group II: ControlActive Control1 Intervention
Randomized selection of recruited participants that will not receive intervention

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,153 Total Patients Enrolled

Media Library

PAL2 (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05061108 — N/A
High Blood Pressure Research Study Groups: Intervention, Control
High Blood Pressure Clinical Trial 2023: PAL2 Highlights & Side Effects. Trial Name: NCT05061108 — N/A
PAL2 (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061108 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible for individuals to take part in this experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently enrolling patients - the study was initially posted in August 8th 2022 and its most recent update happened at September 29th of the same year. 500 participants are required for this experiment located within a single site."

Answered by AI

How many participants are recruited for this trial?

"Affirmative. Current details on clinicaltrials.gov confirms this research is in the process of recruitment, having been launched on August 8th 2022 and edited most recently on September 29th 2022. The investigation requires 500 volunteers at a single medical facility to participate."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Wayne Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Linkage, Empowerment, and Access to Prevent Hypertension
Phillip Levy 2022. "Linkage, Empowerment, and Access to Prevent Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061108.
All > Hypertension
~152 spots leftby Sep 2025
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