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Cardiovascular DiseasesFAITH!NCT03084822

Cardiovascular Health Promotion Among African-Americans by FAITH!

A study testing FAITH! App digital intervention in people with Cardiovascular Diseases and Prevention, run by Mayo Clinic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
FAITH! App digital intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Mar 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

About this study

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

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.

Being tested
FAITH! App digital intervention
Medical subject headings
Cardiovascular Diseases, Motor Activity, Diabetes Mellitus, Hypertension, Hypercholesterolemia, Glucose Intolerance, Smoking Cessation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAITH! App digital interventionBehavioural

    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.

Study groups in NCT03084822
Study groupRoleWhat they receive
FAITH! App digital interventionExperimentalThe 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.
Receives: Behavioral: FAITH! App digital intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)

    Change in self reported diet

    Measured: 28 weeks post-intervention

  2. Physical activity behavior

    Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity

    Measured: 28 weeks post-intervention

  3. 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.

    Measured: 28 weeks post-intervention

  4. 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

    Measured: 28 weeks post-intervention

Secondary outcomes (8)

  1. Intervention feasibility

    Participant retention (goal >80% of enrolled participants)

    Measured: 28 weeks post-intervention

  2. BMI

    Change from baseline BMI

    Measured: 28 weeks post-intervention

  3. Blood Pressure

    Change from baseline blood pressure

    Measured: 28 weeks post-intervention

  4. Fasting Cholesterol

    Change from baseline cholesterol

    Measured: 28 weeks post-intervention

  5. Fasting glucose

    Change from baseline fasting glucose

    Measured: 28 weeks post-intervention

  6. Smoking (using adaptation of Global Adult Tobacco Survey)

    Change in self reported smoking status

    Measured: 28 weeks post-intervention

  7. 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.

    Measured: 28 weeks post-intervention

  8. Cardiovascular health knowledge

    Change in percent correct from baseline knowledge and attitudes about CVD

    Measured: 28 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study startMar 2016
  3. Primary completionJun 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084822
Sponsor's protocol ID
16-000353
Acronym
FAITH!
Status last verified
Mar 2023
First submitted
1 Mar 2017
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33200999

  • 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.

    PubMed 31430294

Questions about this trial

What is this clinical trial studying?

A study testing FAITH! App digital intervention in people with Cardiovascular Diseases and Prevention, run by Mayo Clinic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener) (time frame: 28 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084822, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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