Techquity by FAITH!

Official title

Techquity by FAITH!: A Cluster Randomized Controlled Trial To Assess the Efficacy of a Community-informed, Cardiovascular Health Promotion Mobile Intervention With Digital Health Advocate Support

Overview

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.

Detailed description

This study addresses cardiovascular health and digital health disparities faced by African-Americans (AAs). We propose three aims to engage with the AA community and build capacity for a digital literacy and cardiovascular health promotion. Aim 1 will engage AA churches to co-design a culturally relevant digital health equity toolkit through an iterative focus group process. In aim 1, we will recruit 20 AAs to represent their churches and be trained as digital health advocates (DHAs) by completing digital health readiness education (using the toolkit developed in aim 1) and cardiovascular health promotion. This advocacy program will be integrated into an existing mobile health intervention, the FAITH! App, in Aim 3. The impact of the community-informed, mHealth intervention, enhanced with DHA support, on AA adults' cardiovascular health will be assessed in a cluster randomized controlled trial. 150 participants will be be randomized to utilize the FAITH! App alone or with the support of the DHA at their church. Cardiovascular health will be assessed at baseline, approximately 3 months, 6 months, and 12 months post-randomization using the American Heart Association's Life's Essential 8 metric for cardiovascular health.

Interventions

• Behavioral 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 encouragi
• Behavioral 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 mainten

Primary outcome measures

• 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]

Secondary outcome measures (9)

• Digital Health Readiness [Time frame: Baseline, 3 months post-randomization]
• Social Support - Diet [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Self Regulation - Diet [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Perceived Barriers - Diet [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Social Support - Physical Activity [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Self Regulation - Physical Activity [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Perceived Barriers - Physical Activity [Time frame: Baseline, 3 months, 6 months, and 12 months post-randomization]
• Artificial Intelligence (AI)-Electrocardiogram (ECG) [Time frame: Baseline, 6 months and 12 months post-randomization]
• Cardio-ankle vascular index (CAVI) [Time frame: Baseline, 6 months and 12 months post-randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06187077 · 23-011118 · 3P50MD017342-03S3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗