Techquity by FAITH!

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Health Equity
• Intervention / Treatment: Behavioral: DHA-Enhanced FAITH! App; Behavioral: FAITH! App

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashton Krogman, MHA; Phone Number: 507-266-2087; Email: krogman.ashton@mayo.edu
• Study Contact Backup: Name: LaPrincess Brewer, MD, MPH; Phone Number: 507-538-2517; Email: Brewer.LaPrincess@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHA-Enhanced FAITH! App; This group will use the FAITH! App with guided support from a Digital Health Advocate (DHA) within their church.	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 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.
Other: FAITH! App; This group will use the FAITH! App on their own, with no DHA support.	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 maintenance phase in which they will have access to use the app as they wish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital Health Readiness	Assessed using a validated, 20-item instrument that captures 5 domains: digital skills, digital usage, digital literacy, digital health literacy, and digital learnability adapted for all digital health technologies such as smartphone apps.	Baseline, 3 months post-randomization
Social Support - Diet	Diet social support measured using the Social Support for Eating Habits Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier eating habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of diet social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for healthy eating.	Baseline, 3 months, 6 months, and 12 months post-randomization
Self Regulation - Diet	Diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (always). A mean of all items is obtained and a difference between the scores is calculated. Higher change in scores indicate more change in use of self-regulation strategies to promote healthy eating.	Baseline, 3 months, 6 months, and 12 months post-randomization
Perceived Barriers - Diet	Changes from baseline to 12 months post-intervention in diet perceived barriers measured by Barriers to Diet and Exercise questionnaire. The 39-item instrument is measured on a five-point scale from 1 (not at all true for me) to 5 (very true for me); participants indicate the extent to which each factor has made it difficult for them to follow appropriate eating and exercise habits in the past 6 months.	Baseline, 3 months, 6 months, and 12 months post-randomization
Social Support - Physical Activity	Physical activity social support measured using the Social Support for Exercise Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier physical activity habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale [from 1 (none) to 5 (very often)]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of physical activity social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for physical activity. Family Participation was calculated as a sum of 10 items: 10 = low to 50 = high; Family Rewards/Punishment as a sum of 3 items: 3 = low to 15 = high; and Friend Participation sum of 10 items: 10 = low to 50 = high.	Baseline, 3 months, 6 months, and 12 months post-randomization
Self Regulation - Physical Activity	Physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a 10-item five-point scale from 1 (never) to 5 (always). The mean of the ten items is obtained. The difference in the mean scores from baseline to 6 months post-intervention is calculated. Larger change in scores indicate more change in self-regulation.	Baseline, 3 months, 6 months, and 12 months post-randomization
Perceived Barriers - Physical Activity	Changes from baseline to 12 months post-intervention in diet perceived barriers measured by Barriers to Diet and Exercise questionnaire. The 39-item instrument is measured on a five-point scale from 1 (not at all true for me) to 5 (very true for me); participants indicate the extent to which each factor has made it difficult for them to follow appropriate eating and exercise habits in the past 6 months.	Baseline, 3 months, 6 months, and 12 months post-randomization
Artificial Intelligence (AI)-Electrocardiogram (ECG)	Standard 12-lead ECG to be analyzed by a Mayo Clinic AI-enhanced ECG model for detection of left ventricular dysfunction and correlation of actual age and AI-ECG predicted age.	Baseline, 6 months and 12 months post-randomization
Cardio-ankle vascular index (CAVI)	The cardio-ankle vascular index (CAVI) is a measure of arterial stiffness that reflects the stiffness from the ascending aorta to the ankle arteries. Normal CAVI values are less than 8 and values greater than or equal to 9 are classified as abnormal.	Baseline, 6 months and 12 months post-randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 23-011118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No