Cardiovascular DiseasesNCT03777709
The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
A study testing FAITH! App in people with Cardiovascular Diseases and Physical Activity, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Physical Activity, Diet Modification
- What is being tested?
- FAITH! App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American race/ethnicity
- 18 years or older
- Own a smart phone
- Have basic Internet navigation skills
- Have at least weekly Internet access (i.e. at home, church, or other public access)
- Have an active email address
Show all 9Show fewer
- Intake of fruits/vegetables less than 5 servings a day
- No engagement in regular physical activity
- Able to engage in moderate physical activity
Who cannot join
- Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
- Pregnant (due to associated hormonal and weight changes)
- Visual/hearing impairment or mental disability that would preclude independent app use
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Being tested
- FAITH! App
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAITH! AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FAITH! App |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 6 months post-intervention
Fasting Glucose (Fingerstick)
Change from baseline to 6 months post-intervention fasting glucose
Measured: 6 months post-intervention
Fasting Lipid Panel
Change in fasting lipid panel from baseline to 6 months post-interventio
Measured: 6 months post-intervention
BMI
Change from baseline BMI at 6 months post-intervention
Measured: 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).
Measured: 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).
Measured: 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:
- fruits and vegetables, ≥4.5 cups/d
- fish, 2 or more 3.5-oz servings/wk
- fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d
- sodium, ≤1500 mg/d
- 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.
Measured: 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:
- fruits and vegetables, ≥4.5 cups/d
- fish, 2 or more 3.5-oz servings/wk
- fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d
- sodium, ≤1500 mg/d
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months post-intervention
Secondary outcomes (10)
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.
Measured: Day 1
Diet Self-Efficacy
Changes from baseline to 6 months post-intervention in diet self-efficacy measured a 5-item scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. Each item is scored on a scale ranging from 0 (certain I cannot) to 100 (certain I can). A mean was calculated to obtain an overall score ranging from 0 (minimum) to 100 (maximum). The difference between the mean scores is calculated. A larger difference indicates larger change in self-efficacy for healthy eating. A negative change between baseline and 6 months post-intervention indicates worsened diet self-efficacy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Feb 2020
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, LaPrincess C. Brewer, Mayo Clinic
- Investigators
- LaPrincess C Brewer, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777709
- Sponsor's protocol ID
- 18-006846
- Other IDs
- 5R21MD013490
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2018
- Last updated
- 2 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35861762
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
- ClinicalTrials.gov ID
- NCT03777709
- Acronym / sponsor ID
- 18-006846
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: FAITH! AppThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- African American race/ethnicity
- 18 years or older
- Own a smart phone
- Have basic Internet navigation skills
- Have at least weekly Internet access (i.e. at home, church, or other public access)
Key exclusion criteria (3 listed)
- Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
- Pregnant (due to associated hormonal and weight changes)
- Visual/hearing impairment or mental disability that would preclude independent app use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAITH! AppParticipants 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. | Behavioural | Intervention |
Primary outcome
Life's Simple 7 Composite Score Change
Time frame: 6 months post-intervention
Change from baseline Life's Simple 7 Composite Score at 6 month post-intervention The Life's Simple 7 Composite Score is adapted from the American Heart Association standards based on health assessment data and is a composite of each component (average BP from 3 readings, fasting lipid panel and glucose, height, weight, self-reported cigarette smoking status, dietary quality, and physical activity patterns). Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal).
Blood Pressure Change
Time frame: 6 months post-intervention
Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)
Fasting Glucose (Fingerstick)
Time frame: 6 months post-intervention
Change from baseline to 6 months post-intervention fasting glucose
Fasting Lipid Panel
Time frame: 6 months post-intervention
Change in fasting lipid panel from baseline to 6 months post-interventio
BMI
Time frame: 6 months post-intervention
Change from baseline BMI at 6 months post-intervention
Smoking Status Category
Time frame: Baseline
Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (<1 year), Ideal = Never or Former (>1 year).
Smoking Status Category
Time frame: 6 Months post-intervention
Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (<1 year), Ideal = Never or Former (>1 year).
Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
Time frame: Immediate post-intervention
Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, < once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.
Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
Time frame: 6 months post-intervention
Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, < once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.
Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
Time frame: Immediate post-intervention
Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity at immediate post-intervention.
Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
Time frame: 6 months post-intervention
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.
Intervention Feasibility Measures - Participant Engagement With Tracking
Time frame: Immediate post-intervention
Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at immediate post-intervention.
Intervention Feasibility Measures - Participant Engagement With Tracking
Time frame: 6 months post-intervention
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 With and Without Engagement With Sharing Board
Time frame: Immediate post-intervention
Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention
Intervention Feasibility Measures - Participant Engagement With Sharing Board
Time frame: Immediate post-intervention
Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention
Intervention Feasibility Measures - Participant Engagement With Modules
Time frame: Immediate post-intervention
App engagement as measured by the number of modules completed by the participants during the intervention. The number of participants who completed <5 and ≥5 modules (out of 10) was calculated.
Intervention Feasibility Measures - App Usability
Time frame: 6 months post-intervention
App usability assesses four domains (Impact, Perceived usefulness, Perceived ease of use, User control) using the Health Information Technology Usability Evaluation Scale (Health-ITUES) instrument. 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The overall Health-ITUES score was calculated as the mean of all 20 items, with each item being equally weighted. Possible total scores range from 1.0 (minimum) to 5.0 (maximum). A higher total sum indicates higher perceived usability of the technology measured at 6 months post-intervention.
10 secondary outcomes
Smoking at Baseline as Assessed by Cigarette Smoking Status
Time frame: Day 1
Diet Self-Efficacy
Time frame: 6 months post-intervention
Diet Self-Regulation
Time frame: 6 months post-intervention
Diet Social Support
Time frame: 6 months post-intervention
Physical Activity Self-Efficacy
Time frame: 6 months post-intervention
Physical Activity Self-Regulation
Time frame: 6 months post-intervention
Physical Activity Social Support
Time frame: 6 months post-intervention
Psychosocial Measures - Religiosity/Spirituality
Time frame: 6 months post-intervention
Psychosocial Measures - Optimism
Time frame: 6 months post-intervention
Psychosocial Measures - Perceived Stress
Time frame: 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35861762Brewer 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LaPrincess C Brewer principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAITH! App in people with Cardiovascular Diseases and Physical Activity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life's Simple 7 Composite Score Change (time frame: 6 months post-intervention). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.