Clinical trial NCT03084822: Cardiovascular Health Promotion Among African-Americans by FAITH!
Official title: Cardiovascular Health Promotion Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health): Engaging the Community Through Mobile Technology-assisted Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Prevention
Physical Activity
Diet Modification
Diabetes
Hypertension
High Cholesterol
Pre Diabetes
Smoking Cessation
Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Mayo Clinic Clinic Center for Innovation
name: Mayo Clinic Center for Clinical and Translational Science (CCaTS)
First posted: 2017-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)
timeFrame: 28 weeks post-intervention
measure: Physical activity behavior
timeFrame: 28 weeks post-intervention
measure: Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)
timeFrame: 28 weeks post-intervention
measure: Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)
timeFrame: 28 weeks post-intervention
Secondary outcomes:
measure: Intervention feasibility
timeFrame: 28 weeks post-intervention
measure: BMI
timeFrame: 28 weeks post-intervention
measure: Blood Pressure
timeFrame: 28 weeks post-intervention
measure: Fasting Cholesterol
timeFrame: 28 weeks post-intervention
measure: Fasting glucose
timeFrame: 28 weeks post-intervention
measure: Smoking (using adaptation of Global Adult Tobacco Survey)
timeFrame: 28 weeks post-intervention
measure: Life's Simple 7 Composite Score
timeFrame: 28 weeks post-intervention
measure: Cardiovascular health knowledge
timeFrame: 28 weeks post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic Department of Cardiovascular Medicine
name: LaPrincess C Brewer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.