The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

Mayo Clinic

Status: Completed

Conditions: Physical Activity; Lifestyle Factors; Cardiovascular Diseases; Diet Modification

Treatments: Behavioral: FAITH! App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03777709

18-006846

5R21MD013490 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. African American race/ethnicity
2. 18 years or older
3. Own a smart phone
4. Have basic Internet navigation skills
5. Have at least weekly Internet access (i.e. at home, church, or other public access)
6. Have an active email address
7. Intake of fruits/vegetables less than 5 servings a day
8. No engagement in regular physical activity
9. Able to engage in moderate physical activity

Exclusion criteria

1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
2. Pregnant (due to associated hormonal and weight changes)
3. Visual/hearing impairment or mental disability that would preclude independent app use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Intervention

Experimental group

Description:

The FAITH! App intervention includes a 10-week core series of multimedia education modules with a LS7 focus and other features including interactive self-quizzes, self-monitoring (diet/physical activity), and social networking. Participants will follow a weekly schedule of each module concentrating on each LS7 component. Personalized messages will be delivered to each participant 3-4 times weekly over the intervention phase through the app dashboard, text message, or email. The sharing board will be moderated weekly to foster discussion on behavior change influences and participant successes/challenges to healthy lifestyle. Participants will maintain app access for the duration of the study.

Treatment:

Behavioral: FAITH! App

Delayed Intervention/Control

No Intervention group

Description:

The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).