NCT06187077 · Mayo Clinic
Techquity by FAITH!
What this study is about
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.
View original scientific description
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.
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 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.
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.
Primary outcome measures
Life's Essential 8 Composite Score change
Time frame: Baseline, 6-months and 12-months post-randomization
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).
Blood Pressure Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
Average of 3 sitting measurements of systolic and diastolic pressures (mmHg).
Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
Fingerstick blood collection (fasting glucose-mg/dL; Hemoglobin A1c-%).
Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
Fingerstick blood collection (mg/dL).
Body Mass Index (BMI) Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
Calculated by weight (kg) and height (m).
Tobacco/Nicotine Exposure Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
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.
Dietary Quality Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
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.
Physical Activity Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
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).
Sleep Health Score Change (Life's Essential 8 Component)
Time frame: Baseline, 6-months and 12-months post-randomization
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Johns Hopkins University, Association of Black Cardiologists
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2025 · Source of record for eligibility and locations