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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03084822
Other study ID # 16-000353
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date June 2018

Study information

Verified date March 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 2018
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic Mayo Clinic Center for Clinical and Translational Science (CCaTS), Mayo Clinic Clinic Center for Innovation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Physical activity behavior Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity 28 weeks post-intervention
Primary 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
Primary 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 Intervention feasibility Participant retention (goal >80% of enrolled participants) 28 weeks post-intervention
Secondary BMI Change from baseline BMI 28 weeks post-intervention
Secondary Blood Pressure Change from baseline blood pressure 28 weeks post-intervention
Secondary Fasting Cholesterol Change from baseline cholesterol 28 weeks post-intervention
Secondary Fasting glucose Change from baseline fasting glucose 28 weeks post-intervention
Secondary Smoking (using adaptation of Global Adult Tobacco Survey) Change in self reported smoking status 28 weeks post-intervention
Secondary 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. 28 weeks post-intervention
Secondary Cardiovascular health knowledge Change in percent correct from baseline knowledge and attitudes about CVD 28 weeks post-intervention
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