Cardiovascular Health Promotion Among African-Americans by FAITH! (FAITH!)
Primary Purpose
Cardiovascular Diseases, Prevention, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FAITH! App digital intervention
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FAITH! App digital intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)
Change in self reported diet
Physical activity behavior
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)
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.
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
Secondary Outcome Measures
Intervention feasibility
Participant retention (goal >80% of enrolled participants)
BMI
Change from baseline BMI
Blood Pressure
Change from baseline blood pressure
Fasting Cholesterol
Change from baseline cholesterol
Fasting glucose
Change from baseline fasting glucose
Smoking (using adaptation of Global Adult Tobacco Survey)
Change in self reported smoking status
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.
Cardiovascular health knowledge
Change in percent correct from baseline knowledge and attitudes about CVD
Full Information
NCT ID
NCT03084822
First Posted
March 1, 2017
Last Updated
March 27, 2023
Sponsor
Mayo Clinic
Collaborators
Mayo Clinic Clinic Center for Innovation, Mayo Clinic Center for Clinical and Translational Science (CCaTS)
1. Study Identification
Unique Protocol Identification Number
NCT03084822
Brief Title
Cardiovascular Health Promotion Among African-Americans by FAITH!
Acronym
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Mayo Clinic Clinic Center for Innovation, Mayo Clinic Center for Clinical and Translational Science (CCaTS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Prevention, Physical Activity, Diet Modification, Diabetes, Hypertension, High Cholesterol, Pre Diabetes, Smoking Cessation, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FAITH! App digital intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FAITH! App digital intervention
Intervention Description
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 Measure Information:
Title
Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)
Description
Change in self reported diet
Time Frame
28 weeks post-intervention
Title
Physical activity behavior
Description
Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity
Time Frame
28 weeks post-intervention
Title
Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)
Description
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.
Time Frame
28 weeks post-intervention
Title
Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)
Description
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
Time Frame
28 weeks post-intervention
Secondary Outcome Measure Information:
Title
Intervention feasibility
Description
Participant retention (goal >80% of enrolled participants)
Time Frame
28 weeks post-intervention
Title
BMI
Description
Change from baseline BMI
Time Frame
28 weeks post-intervention
Title
Blood Pressure
Description
Change from baseline blood pressure
Time Frame
28 weeks post-intervention
Title
Fasting Cholesterol
Description
Change from baseline cholesterol
Time Frame
28 weeks post-intervention
Title
Fasting glucose
Description
Change from baseline fasting glucose
Time Frame
28 weeks post-intervention
Title
Smoking (using adaptation of Global Adult Tobacco Survey)
Description
Change in self reported smoking status
Time Frame
28 weeks post-intervention
Title
Life's Simple 7 Composite Score
Description
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.
Time Frame
28 weeks post-intervention
Title
Cardiovascular health knowledge
Description
Change in percent correct from baseline knowledge and attitudes about CVD
Time Frame
28 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaPrincess C Brewer, MD, MPH
Organizational Affiliation
Mayo Clinic Department of Cardiovascular Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33200999
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.
Results Reference
derived
PubMed Identifier
31430294
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.
Results Reference
derived
Learn more about this trial
Cardiovascular Health Promotion Among African-Americans by FAITH!
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