Cardiovascular Diseases, Diet Modification, Lifestyle Factors, Physical Activity
Conditions
Brief summary
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.
Interventions
BEHAVIORALFAITH! App
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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. African American race/ethnicity 2. 18 years or older 3. Own a smart phone 4. Have basic Internet navigation skills 5. Have at least weekly Internet access (i.e. at home, church, or other public access) 6. Have an active email address 7. Intake of fruits/vegetables less than 5 servings a day 8. No engagement in regular physical activity 9. Able to engage in moderate physical activity
Exclusion criteria
1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping 2. Pregnant (due to associated hormonal and weight changes) 3. Visual/hearing impairment or mental disability that would preclude independent app use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility Measures - App Usability | 6 months post-intervention | 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. |
| Blood Pressure Change | 6 months post-intervention | Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures) |
| Fasting Glucose (Fingerstick) | 6 months post-intervention | Change from baseline to 6 months post-intervention fasting glucose |
| Fasting Lipid Panel | 6 months post-intervention | Change in fasting lipid panel from baseline to 6 months post-interventio |
| BMI | 6 months post-intervention | Change from baseline BMI at 6 months post-intervention |
| Smoking Status Category | Baseline | 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). |
| Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) | Immediate post-intervention | 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. |
| Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | Immediate post-intervention | Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention. |
| Intervention Feasibility Measures - Participant Engagement With Tracking | Immediate post-intervention | Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at immediate post-intervention. |
| Intervention Feasibility Measures - Participant Engagement With Sharing Board | Immediate post-intervention | Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention |
| Intervention Feasibility Measures - Participant Engagement With Modules | Immediate post-intervention | 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. |
| Number of Participants With and Without Engagement With Sharing Board | Immediate post-intervention | Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention |
| Life's Simple 7 Composite Score Change | 6 months post-intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet Self-Efficacy | 6 months post-intervention | 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. |
| Diet Self-Regulation | 6 months post-intervention | 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. |
| Diet Social Support | 6 months post-intervention | 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. |
| Physical Activity Self-Efficacy | 6 months post-intervention | 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. |
| Physical Activity Self-Regulation | 6 months post-intervention | 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. |
| Physical Activity Social Support | 6 months post-intervention | 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. |
| Psychosocial Measures - Religiosity/Spirituality | 6 months post-intervention | 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. |
| Psychosocial Measures - Optimism | 6 months post-intervention | 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. |
| Psychosocial Measures - Perceived Stress | 6 months post-intervention | 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. |
| Smoking at Baseline as Assessed by Cigarette Smoking Status | Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through various methods including phone calls, flyers, email, social media, and pastor referrals from February 2020 to October 2020. In-person and virtual kickoff events were held for study overview and open discussion forums, and the study principal investigator recorded a promotional video detailing study requirements and participant expectations. Interested individuals completed an electronic Participant Interest/Eligibility Form, submitted to the study team.
Participants by arm
| Arm | Count |
|---|---|
| Intervention The FAITH! App intervention includes a 10-week core series of multimedia education modules with a LS7 focus and other features including interactive self-quizzes, self-monitoring (diet/physical activity), and social networking. Participants will follow a weekly schedule of each module concentrating on each LS7 component. Personalized messages will be delivered to each participant 3-4 times weekly over the intervention phase through the app dashboard, text message, or email. The sharing board will be moderated weekly to foster discussion on behavior change influences and participant successes/challenges to healthy lifestyle. Participants will maintain app access for the duration of the study.
FAITH! App: 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. | 34 |
| Intervention The FAITH! App intervention includes a 10-week core series of multimedia education modules with a LS7 focus and other features including interactive self-quizzes, self-monitoring (diet/physical activity), and social networking. Participants will follow a weekly schedule of each module concentrating on each LS7 component. Personalized messages will be delivered to each participant 3-4 times weekly over the intervention phase through the app dashboard, text message, or email. The sharing board will be moderated weekly to foster discussion on behavior change influences and participant successes/challenges to healthy lifestyle. Participants will maintain app access for the duration of the study.
FAITH! App: 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. | 8 |
| Delayed Intervention/Control The delayed intervention group will not receive additional materials while under the control time point (intervention group within intervention/maintenance phases). | 42 |
| Delayed Intervention/Control The delayed intervention group will not receive additional materials while under the control time point (intervention group within intervention/maintenance phases). | 8 |
| Total | 92 |
Baseline characteristics
| Characteristic | Total | Delayed Intervention/Control | Intervention |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 12.3 | 52.1 years STANDARD_DEVIATION 11.4 | 54.7 years STANDARD_DEVIATION 12.9 |
| Current cigarette smoker Missing | 1 Participants | 1 Participants | 0 Participants |
| Current cigarette smoker No | 73 Participants | 40 Participants | 33 Participants |
| Current cigarette smoker Yes | 2 Participants | 1 Participants | 1 Participants |
| Education Level College graduate or higher | 28 Participants | 14 Participants | 14 Participants |
| Education Level High school graduate or less | 8 Participants | 4 Participants | 4 Participants |
| Education Level Missing | 4 Participants | 4 Participants | 0 Participants |
| Education Level Some college | 23 Participants | 14 Participants | 9 Participants |
| Education Level Technical or Associate's degree | 13 Participants | 6 Participants | 7 Participants |
| Electronic health literacy score | 27.9 units on a scale STANDARD_DEVIATION 6 | 28.2 units on a scale STANDARD_DEVIATION 5.4 | 24.7 units on a scale STANDARD_DEVIATION 6.9 |
| Employment Status Employed, at least Part-Time | 56 Participants | 30 Participants | 26 Participants |
| Employment Status Missing | 4 Participants | 4 Participants | 0 Participants |
| Employment Status Retired | 10 Participants | 6 Participants | 4 Participants |
| Employment Status Unemployed | 6 Participants | 2 Participants | 4 Participants |
| Has healthcare professional, seen on regular basis No | 17 Participants | 9 Participants | 8 Participants |
| Has healthcare professional, seen on regular basis Yes | 59 Participants | 33 Participants | 26 Participants |
| Healthcare Insurance Missing | 4 Participants | 4 Participants | 0 Participants |
| Healthcare Insurance No/Don't Know | 8 Participants | 4 Participants | 4 Participants |
| Healthcare Insurance Yes | 64 Participants | 34 Participants | 30 Participants |
| Health conditions as communicated by a healthcare professional Diabetes Missing | 2 Participants | 0 Participants | 2 Participants |
| Health conditions as communicated by a healthcare professional Diabetes No | 54 Participants | 33 Participants | 21 Participants |
| Health conditions as communicated by a healthcare professional Diabetes Yes | 20 Participants | 9 Participants | 11 Participants |
| Health conditions as communicated by a healthcare professional High blood pressure Missing | 0 Participants | 0 Participants | 0 Participants |
| Health conditions as communicated by a healthcare professional High blood pressure No | 29 Participants | 16 Participants | 13 Participants |
| Health conditions as communicated by a healthcare professional High blood pressure Yes | 47 Participants | 26 Participants | 21 Participants |
| Health conditions as communicated by a healthcare professional High cholesterol Missing | 0 Participants | 0 Participants | 0 Participants |
| Health conditions as communicated by a healthcare professional High cholesterol No | 44 Participants | 25 Participants | 19 Participants |
| Health conditions as communicated by a healthcare professional High cholesterol Yes | 32 Participants | 17 Participants | 15 Participants |
| Health conditions as communicated by a healthcare professional Weight 20 pounds or more over ideal weight for your height and build Missing | 0 Participants | 0 Participants | 0 Participants |
| Health conditions as communicated by a healthcare professional Weight 20 pounds or more over ideal weight for your height and build No | 22 Participants | 10 Participants | 12 Participants |
| Health conditions as communicated by a healthcare professional Weight 20 pounds or more over ideal weight for your height and build Yes | 54 Participants | 32 Participants | 22 Participants |
| Household Income Category <$35,000 | 14 Participants | 6 Participants | 8 Participants |
| Household Income Category $35,000-$49,999 | 14 Participants | 11 Participants | 3 Participants |
| Household Income Category $50,000-$74,999 | 21 Participants | 9 Participants | 12 Participants |
| Household Income Category >=$75,000 | 15 Participants | 8 Participants | 7 Participants |
| Household Income Category Not disclosed | 12 Participants | 8 Participants | 4 Participants |
| Marital Status Divorced | 10 Participants | 7 Participants | 3 Participants |
| Marital Status Married or committed relationship | 41 Participants | 19 Participants | 22 Participants |
| Marital Status Missing | 4 Participants | 4 Participants | 0 Participants |
| Marital Status Single | 20 Participants | 11 Participants | 9 Participants |
| Marital Status Widowed | 1 Participants | 1 Participants | 0 Participants |
| Mobile technology/Internet use skills | 4.0 units on a scale STANDARD_DEVIATION 1.1 | 4.1 units on a scale STANDARD_DEVIATION 1 | 3.9 units on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Identify as African-American No | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Identify as African-American Yes | 76 Participants | 42 Participants | 34 Participants |
| Sex: Female, Male Female | 54 Participants | 30 Participants | 24 Participants |
| Sex: Female, Male Male | 22 Participants | 12 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 44 |
| other Total, other adverse events | 0 / 41 | 0 / 44 |
| serious Total, serious adverse events | 0 / 41 | 0 / 44 |
Outcome results
Primary
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
Population: Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Blood Pressure Change | Systolic BP | -3.09 mmHg | Standard Deviation 11.61 |
| Intervention | Blood Pressure Change | Diastolic BP | -0.53 mmHg | Standard Deviation 8.27 |
| Delayed Intervention/Control | Blood Pressure Change | Systolic BP | -7.25 mmHg | Standard Deviation 13.14 |
| Delayed Intervention/Control | Blood Pressure Change | Diastolic BP | -2.5 mmHg | Standard Deviation 11.85 |
Primary
BMI
Change from baseline BMI at 6 months post-intervention
Time frame: 6 months post-intervention
Population: Number of participants analyzed reflects number of participants able to attend and complete in person health assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | BMI | -0.16 kg/m^2 | Standard Deviation 1.3 |
| Delayed Intervention/Control | BMI | 0.14 kg/m^2 | Standard Deviation 2.24 |
Primary
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
Population: Number of participants analyzed reflects number of participants who completed the online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) | 0.79 score on a scale | Standard Deviation 0.86 |
| Delayed Intervention/Control | Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) | -0.08 score on a scale | Standard Deviation 1.19 |
Primary
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
Population: Number of participants analyzed reflects number of participants who completed the online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) | 1.9 score on a scale | Standard Deviation 1.2 |
| Delayed Intervention/Control | Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) | 1.4 score on a scale | Standard Deviation 1.2 |
Primary
Fasting Glucose (Fingerstick)
Change from baseline to 6 months post-intervention fasting glucose
Time frame: 6 months post-intervention
Population: Number of participants analyzed reflects number of participants who adhered to protocol for fasting glucose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Fasting Glucose (Fingerstick) | 2.89 mg/dL | Standard Deviation 18.44 |
| Delayed Intervention/Control | Fasting Glucose (Fingerstick) | 6.73 mg/dL | Standard Deviation 10.64 |
Primary
Fasting Lipid Panel
Change in fasting lipid panel from baseline to 6 months post-interventio
Time frame: 6 months post-intervention
Population: Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Fasting Lipid Panel | -10.96 mg/dL | Standard Deviation 25.88 |
| Delayed Intervention/Control | Fasting Lipid Panel | -17.74 mg/dL | Standard Deviation 25.93 |
Primary
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
Population: Number of participants analyzed reflects number of participants who completed the questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Intervention Feasibility Measures - App Usability | Overall score | 4.2 score on a scale | Standard Deviation 0.7 |
| Intervention | Intervention Feasibility Measures - App Usability | Impact | 4.6 score on a scale | Standard Deviation 0.6 |
| Intervention | Intervention Feasibility Measures - App Usability | Perceived Usefulness | 4.4 score on a scale | Standard Deviation 0.7 |
| Intervention | Intervention Feasibility Measures - App Usability | Perceived Ease Of Use | 3.9 score on a scale | Standard Deviation 1.2 |
| Intervention | Intervention Feasibility Measures - App Usability | User Control | 3.7 score on a scale | Standard Deviation 1 |
| Delayed Intervention/Control | Intervention Feasibility Measures - App Usability | User Control | 3.9 score on a scale | Standard Deviation 0.8 |
| Delayed Intervention/Control | Intervention Feasibility Measures - App Usability | Perceived Ease Of Use | 4.2 score on a scale | Standard Deviation 0.8 |
| Delayed Intervention/Control | Intervention Feasibility Measures - App Usability | Impact | 4.2 score on a scale | Standard Deviation 0.5 |
| Delayed Intervention/Control | Intervention Feasibility Measures - App Usability | Overall score | 4.1 score on a scale | Standard Deviation 0.6 |
| Delayed Intervention/Control | Intervention Feasibility Measures - App Usability | Perceived Usefulness | 4.1 score on a scale | Standard Deviation 0.6 |
Primary
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
Population: App usage data as recorded by the mobile device. Number of participants analyzed reflects number of participants connected to app.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Intervention Feasibility Measures - Participant Engagement With Modules | <5 modules completed | 21 Participants |
| Intervention | Intervention Feasibility Measures - Participant Engagement With Modules | ≥5 modules completed | 13 Participants |
| Delayed Intervention/Control | Intervention Feasibility Measures - Participant Engagement With Modules | <5 modules completed | 21 Participants |
| Delayed Intervention/Control | Intervention Feasibility Measures - Participant Engagement With Modules | ≥5 modules completed | 21 Participants |
Primary
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
Population: App usage data as recorded by the device. Number of participants analyzed reflects number of participants connected to app.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Intervention Feasibility Measures - Participant Engagement With Sharing Board | 5 Participants |
| Delayed Intervention/Control | Intervention Feasibility Measures - Participant Engagement With Sharing Board | 10 Participants |
Primary
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
Population: Number of participants analyzed reflects number of participants who utilized tracking features.~Outcome for Arm 2 (Control/Delayed Intervention group) is not shown as this group did not have access to the FAITH! App and as such could not have participated in the described outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | At least one entry - fruit/veggie tracking | No | 7 Participants |
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | At least one entry - fruit/veggie tracking | Yes | 23 Participants |
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | At least one entry - Fitbit steps | No | 7 Participants |
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | At least one entry - Fitbit steps | Yes | 23 Participants |
Primary
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
Population: Number of participants analyzed reflects number of participants who utilized tracking feature.~Outcome for Arm 2 (Control/Delayed Intervention group) is not shown as this group did not have access to the FAITH! App and as such could not have participated in the described outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | >=1 diet tracking entry | 23 Participants |
| Intervention | Intervention Feasibility Measures - Participant Engagement With Tracking | >=1 physical activity/steps tracking entry | 23 Participants |
Primary
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
Population: Number of participants analyzed reflects number of participants able to attend and complete in person health assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Life's Simple 7 Composite Score Change | 1.88 units on a scale | Standard Deviation 1.85 |
| Delayed Intervention/Control | Life's Simple 7 Composite Score Change | 0.74 units on a scale | Standard Deviation 1.69 |
Comparison: Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).p-value: <0.0001Regression, Linear
Primary
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
Population: At least one app discussion board post. Number of participants analyzed reflects number of participants connected to app.~Outcome for Arm 2 (Control/Delayed Intervention group) is not shown as this group did not have access to the FAITH! App and as such could not have participated in the described outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With and Without Engagement With Sharing Board | No | 26 Participants |
| Intervention | Number of Participants With and Without Engagement With Sharing Board | Yes | 4 Participants |
Primary
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
Population: Differences in overall analyzed and specific rows are due to unanswered/missing survey data from participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | Total minutes vigorous activity in the past week | 91.8 minutes/week | Standard Deviation 192.1 |
| Intervention | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | Total minutes moderate activity in the past week | 168.6 minutes/week | Standard Deviation 238.5 |
| Delayed Intervention/Control | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | Total minutes vigorous activity in the past week | 98.5 minutes/week | Standard Deviation 129.3 |
| Delayed Intervention/Control | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | Total minutes moderate activity in the past week | 80.7 minutes/week | Standard Deviation 90 |
Primary
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
Population: Number of participants analyzed reflects number of participants who completed the online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | 219.70 minutes/week | Standard Deviation 396.73 |
| Delayed Intervention/Control | Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) | 76.09 minutes/week | Standard Deviation 286.67 |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Smoking Status Category | Ideal | 28 Participants |
| Intervention | Smoking Status Category | Intermediate | 1 Participants |
| Intervention | Smoking Status Category | Missing | 0 Participants |
| Intervention | Smoking Status Category | Poor | 1 Participants |
| Delayed Intervention/Control | Smoking Status Category | Intermediate | 0 Participants |
| Delayed Intervention/Control | Smoking Status Category | Ideal | 37 Participants |
| Delayed Intervention/Control | Smoking Status Category | Missing | 1 Participants |
| Delayed Intervention/Control | Smoking Status Category | Poor | 0 Participants |
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Smoking Status Category | Missing | 0 Participants |
| Intervention | Smoking Status Category | Poor | 1 Participants |
| Intervention | Smoking Status Category | Intermediate | 1 Participants |
| Intervention | Smoking Status Category | Ideal | 28 Participants |
| Delayed Intervention/Control | Smoking Status Category | Ideal | 27 Participants |
| Delayed Intervention/Control | Smoking Status Category | Missing | 1 Participants |
| Delayed Intervention/Control | Smoking Status Category | Intermediate | 9 Participants |
| Delayed Intervention/Control | Smoking Status Category | Poor | 1 Participants |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Diet Self-Efficacy | 0.86 score on a scale | Standard Deviation 21.19 |
| Delayed Intervention/Control | Diet Self-Efficacy | -5.30 score on a scale | Standard Deviation 17.09 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Diet Self-Regulation | Increase fruit/vegetable and grains | 0.43 score on a scale | Standard Deviation 0.76 |
| Intervention | Diet Self-Regulation | Decrease fat and calories | 0.31 score on a scale | Standard Deviation 0.69 |
| Intervention | Diet Self-Regulation | Plan and track nutrition | 0.68 score on a scale | Standard Deviation 1.05 |
| Delayed Intervention/Control | Diet Self-Regulation | Increase fruit/vegetable and grains | 0.34 score on a scale | Standard Deviation 0.7 |
| Delayed Intervention/Control | Diet Self-Regulation | Decrease fat and calories | 0.18 score on a scale | Standard Deviation 0.78 |
| Delayed Intervention/Control | Diet Self-Regulation | Plan and track nutrition | 0.02 score on a scale | Standard Deviation 1.03 |
Secondary
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
Population: Number analyzed in specific rows may differ from overall number analyzed due to missing/unanswered responses from survey participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Diet Social Support | Friend discouragement | 0.61 score on a scale | Standard Deviation 3.54 |
| Intervention | Diet Social Support | Family Discouragement | 0.28 score on a scale | Standard Deviation 3.63 |
| Intervention | Diet Social Support | Friend Encouragement | 0.50 score on a scale | Standard Deviation 4.64 |
| Intervention | Diet Social Support | Family Encouragement | 1.33 score on a scale | Standard Deviation 5.27 |
| Delayed Intervention/Control | Diet Social Support | Friend discouragement | 2.18 score on a scale | Standard Deviation 5.82 |
| Delayed Intervention/Control | Diet Social Support | Family Encouragement | 0.21 score on a scale | Standard Deviation 4.21 |
| Delayed Intervention/Control | Diet Social Support | Friend Encouragement | 0.53 score on a scale | Standard Deviation 4.21 |
| Delayed Intervention/Control | Diet Social Support | Family Discouragement | 2.28 score on a scale | Standard Deviation 5.1 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Physical Activity Self-Efficacy | Exercise confidence: Sticking to it | -0.12 score on a scale | Standard Deviation 0.7 |
| Intervention | Physical Activity Self-Efficacy | Exercise confidence: Making time for exercise | -0.39 score on a scale | Standard Deviation 0.85 |
| Delayed Intervention/Control | Physical Activity Self-Efficacy | Exercise confidence: Sticking to it | -0.10 score on a scale | Standard Deviation 0.64 |
| Delayed Intervention/Control | Physical Activity Self-Efficacy | Exercise confidence: Making time for exercise | 0.00 score on a scale | Standard Deviation 0.68 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Activity Self-Regulation | 0.56 score on a scale | Standard Deviation 0.7 |
| Delayed Intervention/Control | Physical Activity Self-Regulation | 0.20 score on a scale | Standard Deviation 0.74 |
Secondary
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
Population: Rows with numbers different than overall number analyzed are due to missing/unanswered survey responses from participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Physical Activity Social Support | Family Participation | 3.12 score on a scale | Standard Deviation 14.47 |
| Intervention | Physical Activity Social Support | Family rewards/punishment | 0.15 score on a scale | Standard Deviation 2.17 |
| Intervention | Physical Activity Social Support | Friend Participation | 3.92 score on a scale | Standard Deviation 9.22 |
| Delayed Intervention/Control | Physical Activity Social Support | Friend Participation | 1.61 score on a scale | Standard Deviation 9.91 |
| Delayed Intervention/Control | Physical Activity Social Support | Family Participation | -0.45 score on a scale | Standard Deviation 7.97 |
| Delayed Intervention/Control | Physical Activity Social Support | Family rewards/punishment | 0.28 score on a scale | Standard Deviation 1.63 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Psychosocial Measures - Optimism | 0.23 score on a scale | Standard Deviation 3.17 |
| Delayed Intervention/Control | Psychosocial Measures - Optimism | -0.26 score on a scale | Standard Deviation 3.18 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Psychosocial Measures - Perceived Stress | -0.08 units on a scale | Standard Deviation 4.14 |
| Delayed Intervention/Control | Psychosocial Measures - Perceived Stress | -0.61 units on a scale | Standard Deviation 5.76 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Psychosocial Measures - Religiosity/Spirituality | 0.07 score on a scale | Standard Deviation 0.47 |
| Delayed Intervention/Control | Psychosocial Measures - Religiosity/Spirituality | 0.14 score on a scale | Standard Deviation 0.46 |
Secondary
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
Population: Number of participants analyzed reflects number of participants who completed online questionnaire. Smoking status was not measured for change over time as it is a categorical variable.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Smoking at Baseline as Assessed by Cigarette Smoking Status | No | 33 Participants |
| Intervention | Smoking at Baseline as Assessed by Cigarette Smoking Status | Yes | 1 Participants |
| Intervention | Smoking at Baseline as Assessed by Cigarette Smoking Status | Missing | 0 Participants |
| Delayed Intervention/Control | Smoking at Baseline as Assessed by Cigarette Smoking Status | Yes | 1 Participants |
| Delayed Intervention/Control | Smoking at Baseline as Assessed by Cigarette Smoking Status | No | 40 Participants |
| Delayed Intervention/Control | Smoking at Baseline as Assessed by Cigarette Smoking Status | Missing | 1 Participants |