Recruiting

FAITH! App

Sponsor:

Mayo Clinic

Code:

NCT06187077

Conditions

Health Equity

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DHA-Enhanced FAITH! App

FAITH! App

Study Details

Brief summary:

The goal of this clinical trial is to engage African-American churches via an established community-academic partnership (FAITH! Program) to build capacity to promote cardiovascular health and digital health equity in African-American faith communities. There are 3 study aims:

Aim 1: Co-design a culturally tailored digital health equity toolkit with community members

Aim 2: Train a network of Digital Health Advocates (DHAs) in digital health equity and cardiovascular health promotion

Aim 3: Test the impact of a DHA-enhanced mobile health intervention (the FAITH! App) on cardiovascular health and digital health readiness among participants

In Aim 1, participants will attend a series of focus groups to share their input on a digital health equity curriculum that will be condensed into a toolkit.

In Aim 2, DHAs will be trained using this toolkit as well as a community health advocacy curriculum to learn how to promote digital health readiness and cardiovascular health in their communities.

Finally, Aim 3 will be a randomized controlled trial where participants will use the FAITH! App to improve their cardiovascular health. Some participants will have the added support of a DHA, and the control group participants will use the app with no additional support to test whether the DHA support is associated with a more significant improvement in cardiovascular health.

Conditions

Health Equity

Cardiovascular Diseases

Study ID

NCT06187077

Start date

Jul 11, 2024

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Aim 1- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, basic Internet navigation skills, active email address

Aim 2- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, ownership of smartphone (supporting iOS or Android systems), moderate to high digital health literacy (by eHealth literacy scale \[eHEALS\], score ≥26)

Aim 3- Inclusion Criteria: African/American race/ethnicity, age ≥ 18 years, ownership of smartphone (supporting iOS or Android systems), low digital health literacy (by eHEALS, score ≤26), basic Internet navigation skills, at least weekly Internet access, active email address, fruit/vegetable intake ≤5 servings/day, no regular physical activity, able to engage in moderate physical activity and willingness to participate in all aspects of the study.

Exclusion Criteria: Unable to walk up ≥2 flights of stairs or walk ≥1 city block without assistance or stopping, pregnant (at time of study enrollment), visual/hearing impairment or mental disability that would preclude independent app use.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DHA-Enhanced FAITH! App

This group will use the FAITH! App with guided support from a Digital Health Advocate (DHA) within their church.

other: FAITH! App

This group will use the FAITH! App on their own, with no DHA support.

Interventions

DHA-Enhanced FAITH! App

This group of participants will follow an 11-week guided intervention with the FAITH! App. Weekly educational modules provide information on components of cardiovascular health (CVH). Participants are given a Fitbit to track physical activity, which will automatically synch to the app and will be asked to track their daily fruit and vegetable intake on the app. DHAs will promote CVH and digital health readiness as peer mentors by guiding participants through the educational modules and encouraging use of the additional interactive app features. During the guided intervention phase, they will facilitate weekly visits with participants in their church, which will follow the FAITH! App modules and integrate a digital health topic. Following the 11-week guided intervention, participants will have a 12-month maintenance phase with access to use the app as they wish.

FAITH! App

This group of participants will follow an 11-week guided intervention with the FAITH! App. Each week, an educational module is completed in the app, which provides information on a component of cardiovascular health. Participants will be given a Fitbit to track their physical activity, which will automatically synch to the app, and will be asked to track their daily fruit and vegetable intake on the app as well. Following the 11-week guided intervention, participants will have a 12-month maintenance phase in which they will have access to use the app as they wish.

Primary outcome measure

  • Life's Essential 8 Composite Score change [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Blood Pressure Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Body Mass Index (BMI) Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Dietary Quality Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Physical Activity Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]
  • Sleep Health Score Change (Life's Essential 8 Component) [ Time Frame: Baseline, 6-months and 12-months post-randomization ]

Central Contacts and Locations

Central contacts

Moen Lainey

507-266-7062Moen.Lainey@mayo.edu

Ashton Krogman, MHA

507-266-2087krogman.ashton@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

LaPrincess Brewer, M.D., M.P.H.

Brewer.LaPrincess@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-08-26.