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CompletedNCT05873153Updated Jul 24, 2026Results posted

A Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension

An interventional study of Health Education and Home Blood Pressure Monitor in Hypertension, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.

Read the detailed description
  • We will randomly assign participants to either the treatment or control group. Participants in the treatment group will be given access to the education or BP monitor. Participants in the control group will receive referrals only to a PCP. We will use pre- and post-intervention to examine baseline data (during randomization) and assess changes in BP status and PCP follow up. A 3 weeks and 3 months assessment will determine BP control and PCP status. By comparing between pre- and post-intervention data, we can identify whether the educational content is effective in improving participants' knowledge, attitude, and health seeking behavior for high BP. By comparing between the treatment and control groups, we can examine to what extent the education and BP monitoring influences the effectiveness of the educational intervention.
  • We will assess reach by tracking and recording the number of community members screened at each screening station, the Mosque and Halal Store. Each person will only be screened at baseline, 6 weeks and 3 months and we will record their systolic and diastolic blood pressures, age, sex, PCP status, and most recent visit with a healthcare provider. Additionally, the CHW will follow up with those that were referred for education and/or PCP visit to identify how many followed through with the recommendations (daily BP check, 30 minutes physical activity, dietary changes). Interviews will be conducted with community members who were referred to PCP and health educators due to high BP to assess the impact of the CHW/educators on their health seeking behaviors including motivation to make changes such as checking blood pressures, making dietary changes, increasing physical activity and seeking primary care, as well as how their experience with peer education was. CHW will also be interviewed to understand their overall perception of screening, suggestions for improvement. Following a community members referral to the champions for acute care needs (if they don't have a PCP or are unable to get in in a timely manner), participants' feedback about their visit with the provider will be collected to assess their overall experience with the provider.

Approach for Aim 2: Test the effectiveness of training Halal staff and Somali leaders to educate community members regarding culturally appropriate dietary recommendations and other lifestyle interventions for hypertension. For this aim Halal store owners and community leaders will keep a weekly record of the number of community members they reached out to. Additionally, community members who receive peer education will be interviewed to determine if the education from the Halal store owners was helpful, and what their experience was like Halal store owners and community leaders will also be interviewed to assess their overall perception of the peer education.

Approach for Aim 3: Build research capacity within the GMHEP members to engage in community-based research projects. Focus group will be conducted with GMHEP members following educational session to determine their experience with research education and comfort with conducting focus groups to peers.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Greater Mankato Somali community members.
  • Non-pregnant.
  • At the Mosque or Halal stores between 5/2/2022-5/31/2023.

Exclusion criteria

Exclusion Criteria:

  • Pregnant.
  • Are not at the Mosque or Halal stores between 5/2/2022-5/31/2023.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Participants will be given access to health education, home blood pressure monitor, and referral to a primary care provider.

    Behavioral: Health Education · Other: Home Blood Pressure Monitor

  • No intervention
    Control Group

    Participants receive referrals only to a primary care provider (PCP) for blood pressure monitoring.

Interventions

  • BehavioralHealth Education

    Education materials on high blood pressure, lowering sodium, starting an exercise program, and weight management.

  • OtherHome Blood Pressure Monitor

    Blood pressure cuff for home use

06

What researchers measure

Primary outcomes

  1. PCP Follow up

    Number of subjects to follow up with a primary care provider

    Time frame: 3 months

07

Results

Posted Jul 24, 2026
Limitations and caveats
Despite extending the recruitment timeframe, it was difficult to recruit unique participants to the study that would be reliable for follow up after 3 months. Additionally, the Somali community had many engagement activities from other community partners focusing on health, so the changes in blood pressure or PCP follow up could be affected by this additional, non study related intervention.

Participant flow

Recruitment occurred from February 2023 through November 2024.

Participant flow — Overall Study
MilestoneIntervention GroupControl Group
Started2119
Completed158
Not completed611

Outcome measures

PrimaryPCP Follow up

Number of subjects to follow up with a primary care provider

Time frame:
3 months
Reported as:
Number · participant
PCP Follow up
participantIntervention GroupControl Group
PCP Follow up15 ± 08 ± 1

Adverse events

Collected over There was no adverse event monitoring as this was a low risk study that only involved education and BP monitoring. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group———
Control Group———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intervention GroupControl GroupTotal
<=18 years000
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Intervention GroupControl GroupTotal
Female639
Male9615
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention GroupControl GroupTotal
Hispanic or Latino000
Not Hispanic or Latino15924
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention GroupControl GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American15924
White000
More than one race000
Unknown or Not Reported000
PCP at baseline
PCP at baseline(participants)Intervention GroupControl GroupTotal
Number12719
08

Study locations

1 site
  • Erin Westfall
    Mankato, Minnesota 56082, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 25, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05873153
Lead sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Erin C. Westfall (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 24, 2023
Start date
Feb 21, 2023
Primary completion
Jul 21, 2025
Completion
Oct 8, 2025
Results posted
Jul 24, 2026
Last update
Jul 24, 2026

Study contacts

Erin Westfall, DO
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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