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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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)
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    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

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