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Completed

NCT Number: NCT03084822

Cardiovascular Health Promotion Among African-Americans by FAITH!

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Body Weight Diabetes Diabetes Mellitus Diet Modification Dyslipidemias Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Health Behavior High Cholesterol Hypercholesterolemia Hyperglycemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Pre Diabetes Prevention Signs and Symptoms Smoking Cessation Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FAITH! App digital intervention

Behavioral

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 outcomes

  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 behavior

    Time frame: 28 weeks post-intervention

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

  3. Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)

    Time frame: 28 weeks post-intervention

    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.

  4. Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)

    Time frame: 28 weeks post-intervention

    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 outcomes

  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; 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.

  8. Cardiovascular health knowledge

    Time frame: 28 weeks post-intervention

    Change in percent correct from baseline knowledge and attitudes about CVD

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Mayo Clinic Center for Clinical and Translational Science (CCaTS)
  • Mayo Clinic Clinic Center for Innovation

Registry information

Official study title

Cardiovascular Health Promotion Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health): Engaging the Community Through Mobile Technology-assisted Education

Acronym: FAITH!

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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