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Clinical Trials/NCT03084822
NCT03084822CompletedNot Applicable

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

Mayo Clinic0 sites50 target enrollmentStarted: March 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
Physical activity behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Physical activity behavior

Time Frame: 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)

Time Frame: 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)

Time Frame: 28 weeks post-intervention

Change in self reported diet

Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)

Time Frame: 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 Outcomes

  • Fasting glucose(28 weeks post-intervention)
  • Smoking (using adaptation of Global Adult Tobacco Survey)(28 weeks post-intervention)
  • Fasting Cholesterol(28 weeks post-intervention)
  • Intervention feasibility(28 weeks post-intervention)
  • BMI(28 weeks post-intervention)
  • Blood Pressure(28 weeks post-intervention)
  • Cardiovascular health knowledge(28 weeks post-intervention)
  • Life's Simple 7 Composite Score(28 weeks post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

LaPrincess C. Brewer

Assistant Professor of Medicine

Mayo Clinic

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