Cardiovascular Health Promotion Among African-Americans by FAITH! (FAITH!)

Cardiovascular Health Promotion Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health): Engaging the Community Through Mobile Technology-assisted Education

Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of healthy lifestyles for CVD prevention and provide support for behavior change.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Smoking Cessation; Hypertension; Obesity; Diabetes; Physical Activity; Diet Modification; Pre Diabetes; Prevention; High Cholesterol
• Intervention / Treatment: Behavioral: FAITH! App digital intervention

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Basic Internet navigation skills, at least weekly Internet access, active email address, minimal fruit/vegetable intake (<5 servings/day), no regular physical activity program (< 30 minutes/d of moderate physical activity), able to engage in moderate physical activity (no restrictions)

Exclusion Criteria:

• Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FAITH! App digital intervention; The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

Behavioral: FAITH! App digital intervention; The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)	Change in self reported diet	28 weeks post-intervention
Physical activity behavior	Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity	28 weeks post-intervention
Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)	Change from baseline self-efficacy; scale of 1-5; Healthy diet score components include the following: fruits and vegetables, ≥4.5 cups/d; fish, 2 or more 3.5-oz servings/wk; fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d; sodium, ≤1500 mg/d; and sugar-sweetened beverages, ≤450 kcal/wk. Dietary recommendations are scaled according to a 2000-kcal/d diet.	28 weeks post-intervention
Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)	Change from baseline self-efficacy. Physical activity is reported via the Self-Regulation Scale from Health Beliefs Survey, which includes 10 items, using a 5-point Likert scale (1=never to 5=always) with higher scores indicating higher PA self-regulation	28 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility	Participant retention (goal >80% of enrolled participants)	28 weeks post-intervention
BMI	Change from baseline BMI	28 weeks post-intervention
Blood Pressure	Change from baseline blood pressure	28 weeks post-intervention
Fasting Cholesterol	Change from baseline cholesterol	28 weeks post-intervention
Fasting glucose	Change from baseline fasting glucose	28 weeks post-intervention
Smoking (using adaptation of Global Adult Tobacco Survey)	Change in self reported smoking status	28 weeks post-intervention
Cardiovascular health knowledge	Change in percent correct from baseline knowledge and attitudes about CVD	28 weeks post-intervention
Life's Simple 7 Composite Score	Change from baseline Life's Simple 7 Composite Score; calculated as a composite of each LS7 component by assigning 2 points for ideal, 1 point for intermediate, or 0 points for poor. The total composite score is assessed on a scale of 0 to 14 points. To categorize, scores of 0 to 6 were labeled "poor', 7 to 8 "intermediate" and 9 to 14 "ideal" cardiovascular health.	28 weeks post-intervention

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Mayo Clinic Clinic Center for Innovation; Mayo Clinic Center for Clinical and Translational Science (CCaTS)
• Investigators: Principal Investigator: LaPrincess C Brewer, MD, MPH, Mayo Clinic Department of Cardiovascular Medicine

Publications and helpful links

General Publications

• Brewer LC, Kumbamu A, Smith C, Jenkins S, Jones C, Hayes SN, Burke L, Cooper LA, Patten CA. A Cardiovascular Health and Wellness Mobile Health Intervention Among Church-Going African Americans: Formative Evaluation of the FAITH! App. JMIR Form Res. 2020 Nov 17;4(11):e21450. doi: 10.2196/21450.
• Brewer LC, Hayes SN, Caron AR, Derby DA, Breutzman NS, Wicks A, Raman J, Smith CM, Schaepe KS, Sheets RE, Jenkins SM, Lackore KA, Johnson J, Jones C, Radecki Breitkopf C, Cooper LA, Patten CA. Promoting cardiovascular health and wellness among African-Americans: Community participatory approach to design an innovative mobile-health intervention. PLoS One. 2019 Aug 20;14(8):e0218724. doi: 10.1371/journal.pone.0218724. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Cardiovascular Diseases; Diabetes Mellitus; Prediabetic State; Hypercholesterolemia
• Other Study ID Numbers: 16-000353

Drug and device information, study documents

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