The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
85
Participants allocated to the intervention arm will complete a 10-week, individual-tailored intervention program utilizing the FAITH! App to promote the AHA LS7 through health education and to increase awareness and skill development while enhancing self-efficacy, self-regulation, and social support for healthy behavior change.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Life's Simple 7 Composite Score Change
Change from baseline Life's Simple 7 Composite Score at 6 month post-intervention The Life's Simple 7 Composite Score is adapted from the American Heart Association standards based on health assessment data and is a composite of each component (average BP from 3 readings, fasting lipid panel and glucose, height, weight, self-reported cigarette smoking status, dietary quality, and physical activity patterns). Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal).
Time frame: 6 months post-intervention
Blood Pressure Change
Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)
Time frame: 6 months post-intervention
Fasting Glucose (Fingerstick)
Change from baseline to 6 months post-intervention fasting glucose
Time frame: 6 months post-intervention
Fasting Lipid Panel
Change in fasting lipid panel from baseline to 6 months post-interventio
Time frame: 6 months post-intervention
BMI
Change from baseline BMI at 6 months post-intervention
Time frame: 6 months post-intervention
Smoking Status Category
Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).
Time frame: Baseline
Smoking Status Category
Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).
Time frame: 6 Months post-intervention
Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.
Time frame: Immediate post-intervention
Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.
Time frame: 6 months post-intervention
Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention.
Time frame: Immediate post-intervention
Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
Change from baseline to 6 months post-intervention in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.
Time frame: 6 months post-intervention
Intervention Feasibility Measures - Participant Engagement With Tracking
Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at immediate post-intervention.
Time frame: Immediate post-intervention
Intervention Feasibility Measures - Participant Engagement With Tracking
Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at 6 months post-intervention
Time frame: 6 months post-intervention
Number of Participants With and Without Engagement With Sharing Board
Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention
Time frame: Immediate post-intervention
Intervention Feasibility Measures - Participant Engagement With Sharing Board
Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention
Time frame: Immediate post-intervention
Intervention Feasibility Measures - Participant Engagement With Modules
App engagement as measured by the number of modules completed by the participants during the intervention. The number of participants who completed \<5 and ≥5 modules (out of 10) was calculated.
Time frame: Immediate post-intervention
Intervention Feasibility Measures - App Usability
App usability assesses four domains (Impact, Perceived usefulness, Perceived ease of use, User control) using the Health Information Technology Usability Evaluation Scale (Health-ITUES) instrument. 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The overall Health-ITUES score was calculated as the mean of all 20 items, with each item being equally weighted. Possible total scores range from 1.0 (minimum) to 5.0 (maximum). A higher total sum indicates higher perceived usability of the technology measured at 6 months post-intervention.
Time frame: 6 months post-intervention
Smoking at Baseline as Assessed by Cigarette Smoking Status
Self reported smoking status at baseline. Participants were asked to self-report current smoking status as "no" (non-smoker currently) or "yes" (current smoker). "Missing" category title indicates the survey response was unanswered.
Time frame: Day 1
Diet Self-Efficacy
Changes from baseline to 6 months post-intervention in diet self-efficacy measured a 5-item scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. Each item is scored on a scale ranging from 0 (certain I cannot) to 100 (certain I can). A mean was calculated to obtain an overall score ranging from 0 (minimum) to 100 (maximum). The difference between the mean scores is calculated. A larger difference indicates larger change in self-efficacy for healthy eating. A negative change between baseline and 6 months post-intervention indicates worsened diet self-efficacy.
Time frame: 6 months post-intervention
Diet Self-Regulation
Changes from baseline to 6 months post-intervention in diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (always). A mean of all items is obtained and a difference between the scores is calculated. Higher change in scores indicate more change in use of self-regulation strategies to promote healthy eating.
Time frame: 6 months post-intervention
Diet Social Support
Changes from baseline to 6 months post-intervention in diet social support using the Social Support for Eating Habits Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier eating habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale \[from 1 (none) to 5 (very often)\]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of diet social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for healthy eating.
Time frame: 6 months post-intervention
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Physical Activity Self-Efficacy
Changes from baseline to 6 months post-intervention in physical activity self-efficacy measured using the Exercise Confidence Survey. The scale assesses the participant's confidence in their ability to exercise when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A mean of 8 items (Exercise confidence: Sticking to it) and 4 items (Exercise confidence: Making time for exercise) are obtained. The difference between baseline and 6 months post-intervention scores is calculated. A higher score indicates higher change in self-efficacy for physical activity.
Time frame: 6 months post-intervention
Physical Activity Self-Regulation
Changes from baseline to 6 months post-intervention in physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a 10-item five-point scale from 1 (never) to 5 (always). The mean of the ten items is obtained. The difference in the mean scores from baseline to 6 months post-intervention is calculated. Larger change in scores indicate more change in self-regulation.
Time frame: 6 months post-intervention
Physical Activity Social Support
Changes from baseline to 6 months post-intervention in diet social support using the Social Support for Exercise Survey scale. This scale assesses the level of encouragement or discouragement from family and friends that participants received for adopting healthier physical activity habits. 5 questions were asked to assess the degree of encouragement and discouragement, separately, on a 5-point scale \[from 1 (none) to 5 (very often)\]. Each sub-item was summed to obtain a score ranging from 5 (lowest) to 25 (highest discouragement/encouragement). The change in level of physical activity social support was calculated from baseline to 6 months post-intervention. Higher scores indicate more change in social support for physical activity. Family Participation was calculated as a sum of 10 items: 10 = low to 50 = high; Family Rewards/Punishment as a sum of 3 items: 3 = low to 15 = high; and Friend Participation sum of 10 items: 10 = low to 50 = high.
Time frame: 6 months post-intervention
Psychosocial Measures - Religiosity/Spirituality
Changes from baseline to 6 months post-intervention in Daily Spiritual Experiences Scale. Scores range from 1 to 6 (attendance), from 1 to 8 (prayer), and from 1 to 4 (religious coping), and from 6 to 36 (spirituality), with higher scores on each measure indicating greater religiosity.
Time frame: 6 months post-intervention
Psychosocial Measures - Optimism
Changes from baseline to 6 months post-intervention in life orientation test-revised scale. Scores range from 6 (least optimistic) to 24 (most optimistic). Participants respond to 3 positively worded items and 3 negatively worded items. Higher scores indicate more optimism.
Time frame: 6 months post-intervention
Psychosocial Measures - Perceived Stress
Changes from baseline to 6 months post-intervention in global perceived stress scale. The instrument measures global perceptions of stressful experiences over the prior 12 months in domains such as employment, legal issues, and racism/discrimination. Participants rate the severity of each domain according to a range from 1 (not stressful) to 3 (very stressful), with a total sum ranging from 0 to 24. Higher total scores indicate more perceived stress.
Time frame: 6 months post-intervention