AzTrials
AzTrials

Health EquityNCT06187077

Techquity by FAITH!

A study testing DHA-Enhanced FAITH! App and FAITH! App in people with Health Equity and Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Health Equity, Cardiovascular Diseases
What is being tested?
DHA-Enhanced FAITH! App and FAITH! App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteUnited States
Study dates
11 Jul 2024to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Aim 1:

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

Exclusion Criteria: Unable to commit to participating in at least 4 focus groups over 4 month period; have visual/hearing impairment or mental disability that would preclude independent involvement in focus group discussions

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)

Exclusion Criteria: Unable to commit to participating in training sessions; have visual/hearing impairment or mental disability that would preclude independent involvement in training and use of FAITH! app

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 at least two flights of stairs or walk at least one city block without assistance or stopping; have visual/hearing impairment or mental disability that would preclude independent use of the app; participant in Aim 1 focus groups; DHA in Aim 2

Aim 4:

Inclusion Criteria: Previously enrolled Aim 3 study participant, Digital Health Advocate, or church leader (including a pastor or designated church representative from a participating church); age ≥ 18 years; willing and able to participate in a virtual focus group.

Exclusion Criteria: Does not meet the Aim 4 inclusion criteria or declines to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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

Read more

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.

Read the 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.

Being tested
DHA-Enhanced FAITH! App, FAITH! App
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHA-Enhanced FAITH! AppBehavioural

    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! AppBehavioural

    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.

Study groups in NCT06187077
Study groupRoleWhat they receive
DHA-Enhanced FAITH! AppExperimentalThis group will use the FAITH! App with guided support from a Digital Health Advocate (DHA) within their church.
Receives: Behavioral: DHA-Enhanced FAITH! App
FAITH! AppOtherThis group will use the FAITH! App on their own, with no DHA support.
Receives: Behavioral: FAITH! App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

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

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

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

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

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

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

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

    Fingerstick blood collection (mg/dL).

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

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

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

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

  6. 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.

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

  7. 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.

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

  8. 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).

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

  9. 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).

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

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, 3 months post-randomization

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start11 Jul 2024
  3. Primary completion13 May 2026
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187077
Sponsor's protocol ID
23-011118
Other IDs
3P50MD017342-03S3
Status last verified
Oct 2026
First submitted
17 Dec 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DHA-Enhanced FAITH! App and FAITH! App in people with Health Equity and Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life's Essential 8 Composite Score change (time frame: Baseline, 6-months and 12-months post-randomization). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in