Techquity by FAITH!
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DHA-Enhanced FAITH! App
BehavioralThis 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! App
BehavioralThis 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: DHA-Enhanced FAITH! AppExperimental treatment 1 intervention
Group B: FAITH! AppOther 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Baseline, 6-months and 12-months post-randomization2
Blood Pressure Score Change (Life's Essential 8 Component)
Average of 3 sitting measurements of systolic and diastolic pressures (mmHg).
Time frame
Baseline, 6-months and 12-months post-randomization3
Fasting Glucose/Hemoglobin A1c Score Change (Life's Essential 8 Component)
Fingerstick blood collection (fasting glucose-mg/dL; Hemoglobin A1c-%).
Time frame
Baseline, 6-months and 12-months post-randomization4
Fasting Blood Lipids Score Change (non-HDL cholesterol) (Life's Essential 8 Component)
Fingerstick blood collection (mg/dL).
Time frame
Baseline, 6-months and 12-months post-randomizationSecondary outcomes
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.
Time frame
Baseline, 3 months post-randomization2
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-randomization3
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-randomization4
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.
Time frame
Baseline, 3 months, 6 months, and 12 months post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Johns Hopkins University
Collaborator
Association of Black Cardiologists
Collaborator
Source ClinicalTrials.gov