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

Reducing Cardiovascular Disparities in the Greater Mankato Somali Community by Utilizing Community-based Interventions to Build Capacity Within the Community to Identify, Manage and Prevent Hypertension

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05873153
Enrollment
40
Registered
2023-05-24
Start date
2023-02-21
Completion date
2025-10-08
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

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.

Interventions

BEHAVIORALHealth Education

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

Blood pressure cuff for home use

Sponsors

Mayo Clinic
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
PCP Follow up3 monthsNumber of subjects to follow up with a primary care provider

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORErin Westfall, DO

Mayo Clinic

Participant flow

Recruitment details

Recruitment occurred from February 2023 through November 2024.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
PCP at baseline19 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
15 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026