Cardiovascular Health Promotion Among African-Americans by FAITH!

Not Applicable

Completed

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

• Registration Number: NCT03084822
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Primary Completion: 2017-06
• Study Completion: 2018-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAITH! App digital intervention	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.

Primary Outcome Measures

Name	Time	Method
Physical activity behavior	28 weeks post-intervention	Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity
Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)	28 weeks post-intervention	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.
Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)	28 weeks post-intervention	Change in self reported diet
Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)	28 weeks post-intervention	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

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	28 weeks post-intervention	Change from baseline fasting glucose
Smoking (using adaptation of Global Adult Tobacco Survey)	28 weeks post-intervention	Change in self reported smoking status
Fasting Cholesterol	28 weeks post-intervention	Change from baseline cholesterol
Intervention feasibility	28 weeks post-intervention	Participant retention (goal \>80% of enrolled participants)
BMI	28 weeks post-intervention	Change from baseline BMI
Blood Pressure	28 weeks post-intervention	Change from baseline blood pressure
Cardiovascular health knowledge	28 weeks post-intervention	Change in percent correct from baseline knowledge and attitudes about CVD
Life's Simple 7 Composite Score	28 weeks post-intervention	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.