Cardiovascular Health Promotion Among African-Americans by FAITH!

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases, Prevention, Physical Activity, Diet Modification, Diabetes, Hypertension, High Cholesterol, Pre Diabetes, Smoking Cessation, Obesity

Intervention / Treatment
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* Behavioral: FAITH! App digital intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAITH! App digital intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| Cardiovascular health knowledge | Change in percent correct from baseline knowledge and attitudes about CVD | 28 weeks post-intervention |