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Cardiovascular Health Promotion Among African-Americans by FAITH! (FAITH!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03084822
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Mayo Clinic Clinic Center for Innovation
Mayo Clinic Center for Clinical and Translational Science (CCaTS)
Information provided by (Responsible Party):
LaPrincess C. Brewer, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Prevention Physical Activity Diet Modification Diabetes Hypertension High Cholesterol Pre Diabetes Smoking Cessation Obesity Behavioral: FAITH! App digital intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FAITH! App digital intervention
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.
Behavioral: FAITH! App digital intervention
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 Measures :
  1. 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

  2. Physical activity (using the International Physical Activity Questionnaire (IPAQ)) [ Time Frame: 28 weeks post-intervention ]
    Change in self reported physical activity

  3. Diet self-efficacy (using Self-Efficacy and Eating Habits Survey) [ Time Frame: 28 weeks post-intervention ]
    Change from baseline self-efficacy

  4. Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey) [ Time Frame: 28 weeks post-intervention ]
    Change from baseline self-efficacy


Secondary Outcome Measures :
  1. Intervention feasibility [ Time Frame: 28 weeks post-intervention ]
    Participant retention (goal >80% of enrolled participants)

  2. BMI [ Time Frame: 28 weeks post-intervention ]
    Change from baseline BMI

  3. Blood Pressure [ Time Frame: 28 weeks post-intervention ]
    Change from baseline blood pressure

  4. Fasting Cholesterol [ Time Frame: 28 weeks post-intervention ]
    Change from baseline cholesterol

  5. Fasting glucose [ Time Frame: 28 weeks post-intervention ]
    Change from baseline fasting glucose

  6. Smoking (using adaptation of Global Adult Tobacco Survey) [ Time Frame: 28 weeks post-intervention ]
    Change in self reported smoking status

  7. Life's Simple 7 Composite Score [ Time Frame: 28 weeks post-intervention ]
    Change from baseline Life's Simple 7 Composite Score

  8. Cardiovascular health knowledge [ Time Frame: 28 weeks post-intervention ]
    Change in percent correct from baseline knowledge and attitudes about CVD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084822


Sponsors and Collaborators
Mayo Clinic
Mayo Clinic Clinic Center for Innovation
Mayo Clinic Center for Clinical and Translational Science (CCaTS)
Investigators
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Principal Investigator: LaPrincess C Brewer, MD, MPH Mayo Clinic Department of Cardiovascular Medicine

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Responsible Party: LaPrincess C. Brewer, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03084822     History of Changes
Other Study ID Numbers: 16-000353
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Cardiovascular Diseases
Prediabetic State
Glucose Intolerance
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders