Techquity by FAITH!

NCT06187077 | Recruiting DMC

• 2 other identifiers: 23-0111183P50MD017342-03S3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Life's Essential 8 Composite Score change

  Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).

  Baseline, 6-months and 12-months post-randomization

• Blood Pressure Score Change (Life's Essential 8 Component)

  Average of 3 sitting measurements of systolic and diastolic pressures (mmHg).

  Baseline, 6-months and 12-months post-randomization

• Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component)

  Fingerstick blood collection (fasting glucose-mg/dL; Hemoglobin A1c-%).

  Baseline, 6-months and 12-months post-randomization

• Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component)

  Fingerstick blood collection (mg/dL).

  Baseline, 6-months and 12-months post-randomization

• Body Mass Index (BMI) Score Change (Life's Essential 8 Component)

  Calculated by weight (kg) and height (m).

  Baseline, 6-months and 12-months post-randomization

• Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component)

  Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past tobacco use habits.

  Baseline, 6-months and 12-months post-randomization

• Dietary Quality Score Change (Life's Essential 8 Component)

  Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern.

  Baseline, 6-months and 12-months post-randomization

• Physical Activity Score Change (Life's Essential 8 Component)

  Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention. Physical activity will be measured by the International Physical Activity Questionnaire (IPAQ).

  Baseline, 6-months and 12-months post-randomization

• Sleep Health Score Change (Life's Essential 8 Component)

  Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).

  Baseline, 6-months and 12-months post-randomization

Secondary Outcomes (9)

• Digital Health Readiness

  Baseline, 3 months post-randomization

• Social Support - Diet

  Baseline, 3 months, 6 months, and 12 months post-randomization

• Self Regulation - Diet

  Baseline, 3 months, 6 months, and 12 months post-randomization

• Perceived Barriers - Diet

  Baseline, 3 months, 6 months, and 12 months post-randomization

• Social Support - Physical Activity

  Baseline, 3 months, 6 months, and 12 months post-randomization

Study Arms (2)

DHA-Enhanced FAITH! App

EXPERIMENTAL

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

Behavioral: DHA-Enhanced FAITH! App

FAITH! App

OTHER

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

Behavioral: FAITH! App

Interventions

DHA-Enhanced FAITH! App BEHAVIORAL

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.

DHA-Enhanced FAITH! App

FAITH! App BEHAVIORAL

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.

FAITH! App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Johns Hopkins University: collaborator
• Association of Black Cardiologists: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• LaPrincess Brewer, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moen Lainey

CONTACT

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

Ashton Krogman, MHA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: July 11, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)