Trial Outcomes & Findings for The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans (NCT NCT03777709)
NCT ID: NCT03777709
Last Updated: 2023-10-02
Results Overview
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).
COMPLETED
NA
85 participants
6 months post-intervention
2023-10-02
Participant Flow
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.
Unit of analysis: site
Participant milestones
| Measure |
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.
|
Delayed Intervention/Control
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Overall Study
STARTED
|
41 8
|
44 8
|
|
Overall Study
COMPLETED
|
34 8
|
42 8
|
|
Overall Study
NOT COMPLETED
|
7 0
|
2 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
Baseline characteristics by cohort
| Measure |
Intervention
n=8 site
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.
|
Delayed Intervention/Control
n=8 site
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
Total
n=16 site
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Identify as African-American · Yes
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Identify as African-American · No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital Status
Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
Single
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Married or committed relationship
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education Level
Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Level
High school graduate or less
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education Level
Some college
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Education Level
Technical or Associate's degree
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education Level
College graduate or higher
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Employment Status
Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment Status
Employed, at least Part-Time
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Employment Status
Retired
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Household Income Category
<$35,000
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Household Income Category
$35,000-$49,999
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Household Income Category
$50,000-$74,999
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Household Income Category
>=$75,000
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Household Income Category
Not disclosed
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Healthcare Insurance
Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Healthcare Insurance
Yes
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Healthcare Insurance
No/Don't Know
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Has healthcare professional, seen on regular basis
Yes
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Has healthcare professional, seen on regular basis
No
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
Weight 20 pounds or more over ideal weight for your height and build · No
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
Weight 20 pounds or more over ideal weight for your height and build · Yes
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
54 Participants
n=5 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
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High blood pressure · No
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High blood pressure · Yes
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High blood pressure · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
Diabetes · No
|
21 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
Diabetes · Yes
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
Diabetes · Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High cholesterol · No
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High cholesterol · Yes
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Health conditions as communicated by a healthcare professional
High cholesterol · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Current cigarette smoker
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current cigarette smoker
No
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Current cigarette smoker
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Electronic health literacy score
|
24.7 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
28.2 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Mobile technology/Internet use skills
|
3.9 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants able to attend and complete in person health assessment.
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).
Outcome measures
| Measure |
Intervention
n=24 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.
|
Delayed Intervention/Control
n=31 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Life's Simple 7 Composite Score Change
|
1.88 units on a scale
Standard Deviation 1.85
|
0.74 units on a scale
Standard Deviation 1.69
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment.
Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)
Outcome measures
| Measure |
Intervention
n=24 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.
|
Delayed Intervention/Control
n=31 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Blood Pressure Change
Systolic BP
|
-3.09 mmHg
Standard Deviation 11.61
|
-7.25 mmHg
Standard Deviation 13.14
|
|
Blood Pressure Change
Diastolic BP
|
-0.53 mmHg
Standard Deviation 8.27
|
-2.5 mmHg
Standard Deviation 11.85
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who adhered to protocol for fasting glucose.
Change from baseline to 6 months post-intervention fasting glucose
Outcome measures
| Measure |
Intervention
n=9 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.
|
Delayed Intervention/Control
n=11 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Fasting Glucose (Fingerstick)
|
2.89 mg/dL
Standard Deviation 18.44
|
6.73 mg/dL
Standard Deviation 10.64
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants able to attend and complete in-person health assessment.
Change in fasting lipid panel from baseline to 6 months post-interventio
Outcome measures
| Measure |
Intervention
n=27 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.
|
Delayed Intervention/Control
n=34 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Fasting Lipid Panel
|
-10.96 mg/dL
Standard Deviation 25.88
|
-17.74 mg/dL
Standard Deviation 25.93
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants able to attend and complete in person health assessment.
Change from baseline BMI at 6 months post-intervention
Outcome measures
| Measure |
Intervention
n=27 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.
|
Delayed Intervention/Control
n=34 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
BMI
|
-0.16 kg/m^2
Standard Deviation 1.30
|
0.14 kg/m^2
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: BaselineChange 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).
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
n=38 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Smoking Status Category
Missing
|
0 Participants
|
1 Participants
|
|
Smoking Status Category
Poor
|
1 Participants
|
1 Participants
|
|
Smoking Status Category
Intermediate
|
1 Participants
|
9 Participants
|
|
Smoking Status Category
Ideal
|
28 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 6 Months post-interventionChange 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).
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
n=38 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Smoking Status Category
Intermediate
|
1 Participants
|
0 Participants
|
|
Smoking Status Category
Ideal
|
28 Participants
|
37 Participants
|
|
Smoking Status Category
Missing
|
0 Participants
|
1 Participants
|
|
Smoking Status Category
Poor
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: Number of participants analyzed reflects number of participants who completed the online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
n=37 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
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
|
1.4 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed the online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=29 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.
|
Delayed Intervention/Control
n=38 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
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
|
-0.08 score on a scale
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: Differences in overall analyzed and specific rows are due to unanswered/missing survey data from participants.
Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention.
Outcome measures
| Measure |
Intervention
n=24 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.
|
Delayed Intervention/Control
n=27 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
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
|
98.5 minutes/week
Standard Deviation 129.3
|
|
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
|
80.7 minutes/week
Standard Deviation 90
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed the online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=20 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.
|
Delayed Intervention/Control
n=23 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
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
|
76.09 minutes/week
Standard Deviation 286.67
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: 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.
Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at immediate post-intervention.
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
At least one entry - fruit/veggie tracking · No
|
7 Participants
|
—
|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
At least one entry - fruit/veggie tracking · Yes
|
23 Participants
|
—
|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
At least one entry - Fitbit steps · No
|
7 Participants
|
—
|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
At least one entry - Fitbit steps · Yes
|
23 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: 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.
Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at 6 months post-intervention
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
>=1 diet tracking entry
|
23 Participants
|
—
|
|
Intervention Feasibility Measures - Participant Engagement With Tracking
>=1 physical activity/steps tracking entry
|
23 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: 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.
Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Number of Participants With and Without Engagement With Sharing Board
No
|
26 Participants
|
—
|
|
Number of Participants With and Without Engagement With Sharing Board
Yes
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: App usage data as recorded by the device. Number of participants analyzed reflects number of participants connected to app.
Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention
Outcome measures
| Measure |
Intervention
n=34 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.
|
Delayed Intervention/Control
n=42 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Intervention Feasibility Measures - Participant Engagement With Sharing Board
|
5 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Immediate post-interventionPopulation: App usage data as recorded by the mobile device. Number of participants analyzed reflects number of participants connected to app.
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.
Outcome measures
| Measure |
Intervention
n=34 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.
|
Delayed Intervention/Control
n=42 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Intervention Feasibility Measures - Participant Engagement With Modules
≥5 modules completed
|
13 Participants
|
21 Participants
|
|
Intervention Feasibility Measures - Participant Engagement With Modules
<5 modules completed
|
21 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed the questionnaire
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.
Outcome measures
| Measure |
Intervention
n=31 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.
|
Delayed Intervention/Control
n=33 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Intervention Feasibility Measures - App Usability
Overall score
|
4.2 score on a scale
Standard Deviation 0.7
|
4.1 score on a scale
Standard Deviation 0.6
|
|
Intervention Feasibility Measures - App Usability
Impact
|
4.6 score on a scale
Standard Deviation 0.6
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Intervention Feasibility Measures - App Usability
Perceived Usefulness
|
4.4 score on a scale
Standard Deviation 0.7
|
4.1 score on a scale
Standard Deviation 0.6
|
|
Intervention Feasibility Measures - App Usability
Perceived Ease Of Use
|
3.9 score on a scale
Standard Deviation 1.2
|
4.2 score on a scale
Standard Deviation 0.8
|
|
Intervention Feasibility Measures - App Usability
User Control
|
3.7 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Intervention
n=34 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.
|
Delayed Intervention/Control
n=42 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Smoking at Baseline as Assessed by Cigarette Smoking Status
No
|
33 Participants
|
40 Participants
|
|
Smoking at Baseline as Assessed by Cigarette Smoking Status
Yes
|
1 Participants
|
1 Participants
|
|
Smoking at Baseline as Assessed by Cigarette Smoking Status
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire
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.
Outcome measures
| Measure |
Intervention
n=29 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.
|
Delayed Intervention/Control
n=28 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Diet Self-Efficacy
|
0.86 score on a scale
Standard Deviation 21.19
|
-5.30 score on a scale
Standard Deviation 17.09
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire
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.
Outcome measures
| Measure |
Intervention
n=29 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.
|
Delayed Intervention/Control
n=37 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Diet Self-Regulation
Increase fruit/vegetable and grains
|
0.43 score on a scale
Standard Deviation 0.76
|
0.34 score on a scale
Standard Deviation 0.70
|
|
Diet Self-Regulation
Decrease fat and calories
|
0.31 score on a scale
Standard Deviation 0.69
|
0.18 score on a scale
Standard Deviation 0.78
|
|
Diet Self-Regulation
Plan and track nutrition
|
0.68 score on a scale
Standard Deviation 1.05
|
0.02 score on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number analyzed in specific rows may differ from overall number analyzed due to missing/unanswered responses from survey participants
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.
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
n=28 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Diet Social Support
Family Encouragement
|
1.33 score on a scale
Standard Deviation 5.27
|
0.21 score on a scale
Standard Deviation 4.21
|
|
Diet Social Support
Family Discouragement
|
0.28 score on a scale
Standard Deviation 3.63
|
2.28 score on a scale
Standard Deviation 5.10
|
|
Diet Social Support
Friend Encouragement
|
0.50 score on a scale
Standard Deviation 4.64
|
0.53 score on a scale
Standard Deviation 4.21
|
|
Diet Social Support
Friend discouragement
|
0.61 score on a scale
Standard Deviation 3.54
|
2.18 score on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire
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.
Outcome measures
| Measure |
Intervention
n=26 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.
|
Delayed Intervention/Control
n=26 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Physical Activity Self-Efficacy
Exercise confidence: Sticking to it
|
-0.12 score on a scale
Standard Deviation 0.70
|
-0.10 score on a scale
Standard Deviation 0.64
|
|
Physical Activity Self-Efficacy
Exercise confidence: Making time for exercise
|
-0.39 score on a scale
Standard Deviation 0.85
|
0.00 score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire
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.
Outcome measures
| Measure |
Intervention
n=26 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.
|
Delayed Intervention/Control
n=27 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Physical Activity Self-Regulation
|
0.56 score on a scale
Standard Deviation 0.70
|
0.20 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Rows with numbers different than overall number analyzed are due to missing/unanswered survey responses from participants
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.
Outcome measures
| Measure |
Intervention
n=26 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.
|
Delayed Intervention/Control
n=36 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Physical Activity Social Support
Family Participation
|
3.12 score on a scale
Standard Deviation 14.47
|
-0.45 score on a scale
Standard Deviation 7.97
|
|
Physical Activity Social Support
Family rewards/punishment
|
0.15 score on a scale
Standard Deviation 2.17
|
0.28 score on a scale
Standard Deviation 1.63
|
|
Physical Activity Social Support
Friend Participation
|
3.92 score on a scale
Standard Deviation 9.22
|
1.61 score on a scale
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=30 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.
|
Delayed Intervention/Control
n=38 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Psychosocial Measures - Religiosity/Spirituality
|
0.07 score on a scale
Standard Deviation 0.47
|
0.14 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=26 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.
|
Delayed Intervention/Control
n=34 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Psychosocial Measures - Optimism
|
0.23 score on a scale
Standard Deviation 3.17
|
-0.26 score on a scale
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Number of participants analyzed reflects number of participants who completed online questionnaire.
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.
Outcome measures
| Measure |
Intervention
n=25 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.
|
Delayed Intervention/Control
n=35 Participants
The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
|
|---|---|---|
|
Psychosocial Measures - Perceived Stress
|
-0.08 units on a scale
Standard Deviation 4.14
|
-0.61 units on a scale
Standard Deviation 5.76
|
Adverse Events
Intervention
Delayed Intervention/Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place