Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R21MD013490 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Delayed Intervention/Control | No Intervention | The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAITH! App | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) | 6 months post-intervention |
| Fasting Glucose (Fingerstick) | Change from baseline to 6 months post-intervention fasting glucose | 6 months post-intervention |
| Fasting Lipid Panel | Change in fasting lipid panel from baseline to 6 months post-interventio | 6 months post-intervention |
| BMI | Change from baseline BMI at 6 months post-intervention | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Diet Self-Efficacy |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LaPrincess C Brewer | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35861762 | Derived | Brewer LC, Jenkins S, Hayes SN, Kumbamu A, Jones C, Burke LE, Cooper LA, Patten CA. Community-Based, Cluster-Randomized Pilot Trial of a Cardiovascular Mobile Health Intervention: Preliminary Findings of the FAITH! Trial. Circulation. 2022 Jul 19;146(3):175-190. doi: 10.1161/CIRCULATIONAHA.122.059046. Epub 2022 Jul 18. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Given the community-based participatory process, it was decided as an academic-community team, that individual participant data will not be available to other researchers from this historically marginalized population.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Delayed Intervention/Control | The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Number of participants analyzed reflects number of participants able to attend and complete in person health assessment. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
|
Participants were monitored during 10 weeks of guided intervention, followed by a maintenance period of 6 months, for a total of approximately 9 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. LaPrincess Brewer | Mayo Clinic | 5072661376 | brewer.laprincess@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2021 | Jun 5, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). | 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:
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. | 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:
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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. |
| 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. | 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. | 6 months post-intervention |
| 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. | 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. | 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. | 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. | 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. | 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. | 6 months post-intervention |
| BG001 | Delayed Intervention/Control | The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases). |
| BG002 | Total | Total of all reporting groups |
| site |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Marital Status | Count of Participants | Participants | Participants |
|
| Education Level | Count of Participants | Participants | Participants |
|
| Employment Status | Count of Participants | Participants | Participants |
|
| Household Income Category | Count of Participants | Participants | Participants |
|
| Healthcare Insurance | Count of Participants | Participants | Participants |
|
| Has healthcare professional, seen on regular basis | Count of Participants | Participants | Participants |
|
| Health conditions as communicated by a healthcare professional | Count of Participants | Participants | Participants |
|
| Current cigarette smoker | Count of Participants | Participants | Participants |
|
| Electronic health literacy score | Sum of 8 items: 8 (low) to 40 (high) | Mean | Standard Deviation | units on a scale | Participants |
|
| Mobile technology/Internet use skills | Mean of 3 items: 1 = low skill to 5 = high skill | Mean | Standard Deviation | units on a scale | Participants |
|
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. |
| OG001 | Delayed Intervention/Control | The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases). |
|
|
|
| Primary | Blood Pressure Change | Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures) | Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment. | Posted | Mean | Standard Deviation | mmHg | 6 months post-intervention |
|
|
|
| Primary | Fasting Glucose (Fingerstick) | Change from baseline to 6 months post-intervention fasting glucose | Number of participants analyzed reflects number of participants who adhered to protocol for fasting glucose. | Posted | Mean | Standard Deviation | mg/dL | 6 months post-intervention |
|
|
|
| Primary | Fasting Lipid Panel | Change in fasting lipid panel from baseline to 6 months post-interventio | Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment. | Posted | Mean | Standard Deviation | mg/dL | 6 months post-intervention |
|
|
|
| Primary | BMI | Change from baseline BMI at 6 months post-intervention | Number of participants analyzed reflects number of participants able to attend and complete in person health assessment. | Posted | Mean | Standard Deviation | kg/m^2 | 6 months post-intervention |
|
|
|
| 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). | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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). | Posted | Count of Participants | Participants | 6 Months post-intervention |
|
|
|
| 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:
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. | Number of participants analyzed reflects number of participants who completed the online questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Immediate post-intervention |
|
|
|
| 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:
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. | Number of participants analyzed reflects number of participants who completed the online questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Differences in overall analyzed and specific rows are due to unanswered/missing survey data from participants. | Posted | Mean | Standard Deviation | minutes/week | Immediate post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed the online questionnaire. | Posted | Mean | Standard Deviation | minutes/week | 6 months post-intervention |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Immediate post-intervention |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 6 months post-intervention |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Immediate post-intervention |
|
|
|
| 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 | App usage data as recorded by the device. Number of participants analyzed reflects number of participants connected to app. | Posted | Count of Participants | Participants | Immediate post-intervention |
|
|
|
| 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. | App usage data as recorded by the mobile device. Number of participants analyzed reflects number of participants connected to app. | Posted | Count of Participants | Participants | Immediate post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number analyzed in specific rows may differ from overall number analyzed due to missing/unanswered responses from survey participants | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Rows with numbers different than overall number analyzed are due to missing/unanswered survey responses from participants | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-intervention |
|
|
|
| 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. | Number of participants analyzed reflects number of participants who completed online questionnaire. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-intervention |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Delayed Intervention/Control | The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases). | 0 | 44 | 0 | 44 | 0 | 44 |
Not provided
Not provided
| Missing |
|
| Missing |
|
| Missing |
|
| Intermediate |
|
| Ideal |
|
| Intermediate |
|
| Ideal |
|
| Total minutes moderate activity in the past week |
|
|
| Yes |
|
| Impact |
|
|
| Perceived Usefulness |
|
|
| Perceived Ease Of Use |
|
|
| User Control |
|
|
| Missing |
|
| Plan and track nutrition |
|
| Family Discouragement |
|
|
| Friend Encouragement |
|
|
| Friend discouragement |
|
|
| Family rewards/punishment |
|
|
| Friend Participation |
|
|