Cardiovascular Health Promotion Among African-Americans by FAITH!

NCT03084822 | Completed

• 1 other identifier: 16-000353
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases; Prevention; Physical Activity; Diet Modification; Diabetes; Hypertension; High Cholesterol; Pre Diabetes; Smoking Cessation; Obesity

Outcome Measures

Primary Outcomes (4)

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

  Change in self reported diet

  28 weeks post-intervention

• Physical activity behavior

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

  28 weeks post-intervention

• 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.

  28 weeks post-intervention

• 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

  28 weeks post-intervention

Secondary Outcomes (8)

• Intervention feasibility

  28 weeks post-intervention

• BMI

  28 weeks post-intervention

• Blood Pressure

  28 weeks post-intervention

• Fasting Cholesterol

  28 weeks post-intervention

• Fasting glucose

  28 weeks post-intervention

Study Arms (1)

FAITH! App digital intervention

EXPERIMENTAL

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

Interventions

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.

FAITH! App digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Related Publications (2)

• 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.

  PMID: 33200999 DERIVED

• 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.

  PMID: 31430294 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Diabetes Mellitus; Hypertension; Hypercholesterolemia; Glucose Intolerance; Smoking Cessation; Obesity

Condition Hierarchy (Ancestors)

Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hyperglycemia; Health Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• LaPrincess C Brewer, MD, MPH

  Mayo Clinic Department of Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 21, 2017
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: March 29, 2023

Record last verified: 2023-03