Cardiovascular Diseases, Diabetes, Diet Modification, High Cholesterol, Hypertension, Obesity, Physical Activity, Pre Diabetes, Prevention, Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALFAITH! 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.
Sponsors
Mayo Clinic Clinic Center for Innovation
Mayo Clinic Center for Clinical and Translational Science (CCaTS)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener) | 28 weeks post-intervention | Change in self reported diet |
| Physical activity behavior | 28 weeks post-intervention | Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity |
| Diet self-efficacy (using Self-Efficacy and Eating Habits Survey) | 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. |
| Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey) | 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
| Measure | Time frame | Description |
|---|---|---|
| BMI | 28 weeks post-intervention | Change from baseline BMI |
| Smoking (using adaptation of Global Adult Tobacco Survey) | 28 weeks post-intervention | Change in self reported smoking status |
| Blood Pressure | 28 weeks post-intervention | Change from baseline blood pressure |
| Cardiovascular health knowledge | 28 weeks post-intervention | Change in percent correct from baseline knowledge and attitudes about CVD |
| Life's Simple 7 Composite Score | 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. |
| Fasting Cholesterol | 28 weeks post-intervention | Change from baseline cholesterol |
| Fasting glucose | 28 weeks post-intervention | Change from baseline fasting glucose |
| Intervention feasibility | 28 weeks post-intervention | Participant retention (goal \>80% of enrolled participants) |
Outcome results
None listed