Cardiovascular Health Promotion Among African-Americans by FAITH!

NCT ID: NCT03084822

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-30

Brief Summary

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Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of healthy lifestyles for CVD prevention and provide support for behavior change.

Detailed Description

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Conditions

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Cardiovascular Diseases Prevention Physical Activity Diet Modification Diabetes Hypertension High Cholesterol Pre Diabetes Smoking Cessation Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FAITH! App digital intervention

The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

Group Type EXPERIMENTAL

FAITH! App digital intervention

Intervention Type BEHAVIORAL

The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

Interventions

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FAITH! App digital intervention

The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Basic Internet navigation skills, at least weekly Internet access, active email address, minimal fruit/vegetable intake (\<5 servings/day), no regular physical activity program (\< 30 minutes/d of moderate physical activity), able to engage in moderate physical activity (no restrictions)

Exclusion Criteria

* Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic Clinic Center for Innovation

UNKNOWN

Sponsor Role collaborator

Mayo Clinic Center for Clinical and Translational Science (CCaTS)

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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LaPrincess C. Brewer

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LaPrincess C Brewer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Department of Cardiovascular Medicine

References

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Brewer LC, Kumbamu A, Smith C, Jenkins S, Jones C, Hayes SN, Burke L, Cooper LA, Patten CA. A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-Going African Americans: Formative Evaluation of the FAITH! App. JMIR Form Res. 2020 Nov 17;4(11):e21450. doi: 10.2196/21450.

Reference Type DERIVED
PMID: 33200999 (View on PubMed)

Brewer LC, Hayes SN, Caron AR, Derby DA, Breutzman NS, Wicks A, Raman J, Smith CM, Schaepe KS, Sheets RE, Jenkins SM, Lackore KA, Johnson J, Jones C, Radecki Breitkopf C, Cooper LA, Patten CA. Promoting cardiovascular health and wellness among African-Americans: Community participatory approach to design an innovative mobile-health intervention. PLoS One. 2019 Aug 20;14(8):e0218724. doi: 10.1371/journal.pone.0218724. eCollection 2019.

Reference Type DERIVED
PMID: 31430294 (View on PubMed)

Other Identifiers

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16-000353

Identifier Type: -

Identifier Source: org_study_id

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