<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777709</url>
  </required_header>
  <id_info>
    <org_study_id>18-006846</org_study_id>
    <secondary_id>5R21MD013490</secondary_id>
    <nct_id>NCT03777709</nct_id>
  </id_info>
  <brief_title>The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans</brief_title>
  <official_title>The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to apply a community-based participatory research (CBPR)&#xD;
      approach to rigorously refine and test the feasibility and preliminary efficacy of an&#xD;
      existing cardiovascular (CV) health and wellness digital application (app) prototype to&#xD;
      improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework&#xD;
      among African-American (AA) adults within faith communities. The investigators hypothesize&#xD;
      that the app-based intervention will be feasible and improve LS7 among AAs from baseline to&#xD;
      6-months post-intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">June 23, 2022</completion_date>
  <primary_completion_date type="Actual">June 23, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Life's Simple 7 Composite Score</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline Life's Simple 7 Composite Score. 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure (average of 3 sitting readings of systolic and diastolic pressures)</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting glucose (fingerstick)</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline fasting glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting lipid panel</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline fasting lipid panel</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline BMI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cigarette smoking status</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change in self reported smoking status from baseline. Participants will be asked to self-report current smoking status as former smoker, current smoker, or never smoked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary Quality (according to American Heart Association guidelines by the validated, culturally appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Change in self reported dietary quality from baseline measured via a culturally relevant checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed. Responses range from never to 2 or more times per day (responses: never, less than 1 time per month, 1 time per month, 2-3 times per month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 times per week, 1 time per day, 2 or more times per day). Calculations for nutrient intake can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient in a serving of that food and then can be compared to the American Heart Association nutrient guidelines. Better adherence of the participant's diet to the guidelines indicates better dietary quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary Quality (according to American Heart Association guidelines by the validated, culturally appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change in self reported dietary quality from baseline measured via a culturally relevant checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed. Responses range from never to 2 or more times per day (responses: never, less than 1 time per month, 1 time per month, 2-3 times per month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 times per week, 1 time per day, 2 or more times per day). Calculations for nutrient intake can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient in a serving of that food and then can be compared to the American Heart Association nutrient guidelines. Better adherence of the participant's diet to the guidelines indicates better dietary quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity patterns (minutes/week of moderate and vigorous intensity physical activity, measured by the International Physical Activity Questionnaire-IPAQ)</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity patterns (minutes/week of moderate and vigorous intensity physical activity, measured by the International Physical Activity Questionnaire-IPAQ)</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Tracking</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Tracking</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Sharing Board</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Participant engagement with sharing board measured by number of posts per month by each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Sharing Board</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Participant engagement with sharing board measured by number of posts per month by each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Modules</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Participant engagement with education modules measured by number of modules completed out of 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - Participant Engagement with Modules</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Participant engagement with education modules measured by number of modules completed out of 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - App Usability</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>App usability measured by Health Information Technology Usability Evaluation Scale (Health-ITUES). 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher total sum indicates higher perceived usability of the technology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility Measures - App Usability</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>App usability measured by Health Information Technology Usability Evaluation Scale (Health-ITUES). 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher total sum indicates higher perceived usability of the technology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet Self-Efficacy</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Self-Efficacy</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Self-Regulation</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline 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 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Self-Regulation</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline 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 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Social Support</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Social Support</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Self-Efficacy</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess 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 higher total sum indicates higher self-efficacy for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Self-Efficacy</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess 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 higher total sum indicates higher self-efficacy for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Self-Regulation</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline 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 five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Self-Regulation</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline 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 five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Social Support</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Social Support</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Measures - Religiosity/Spirituality</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Measures - Optimism</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Measures - Perceived Stress</measure>
    <time_frame>6 months post-intervention</time_frame>
    <description>Changes from baseline 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Physical Activity</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Intervention/Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The delayed intervention group will not receive additional materials while under the &quot;control&quot; time point (intervention group within intervention/maintenance phases).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FAITH! App</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. African American race/ethnicity&#xD;
&#xD;
          2. 18 years or older&#xD;
&#xD;
          3. Own a smart phone&#xD;
&#xD;
          4. Have basic Internet navigation skills&#xD;
&#xD;
          5. Have at least weekly Internet access (i.e. at home, church, or other public access)&#xD;
&#xD;
          6. Have an active email address&#xD;
&#xD;
          7. Intake of fruits/vegetables less than 5 servings a day&#xD;
&#xD;
          8. No engagement in regular physical activity&#xD;
&#xD;
          9. Able to engage in moderate physical activity&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without&#xD;
             assistance or stopping&#xD;
&#xD;
          2. Pregnant (due to associated hormonal and weight changes)&#xD;
&#xD;
          3. Visual/hearing impairment or mental disability that would preclude independent app use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LaPrincess C Brewer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>July 6, 2022</last_update_submitted>
  <last_update_submitted_qc>July 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>LaPrincess C. Brewer</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, College of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 5, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>July 20, 2023</submitted>
    <returned>August 10, 2023</returned>
    <submitted>September 1, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777709
org study id: 18-006846
secondary id: 5R21MD013490
nct id: NCT03777709
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Life's Simple 7 Composite Score
time frame: 6 months post-intervention
description: Change from baseline Life's Simple 7 Composite Score. 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).
measure: Blood Pressure (average of 3 sitting readings of systolic and diastolic pressures)
time frame: 6 months post-intervention
description: Change from baseline blood pressure
measure: Fasting glucose (fingerstick)
time frame: 6 months post-intervention
description: Change from baseline fasting glucose
measure: Fasting lipid panel
time frame: 6 months post-intervention
description: Change from baseline fasting lipid panel
measure: BMI
time frame: 6 months post-intervention
description: Change from baseline BMI
measure: Cigarette smoking status
time frame: 6 months post-intervention
description: Change in self reported smoking status from baseline. Participants will be asked to self-report current smoking status as former smoker, current smoker, or never smoked.
measure: 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
description: Change in self reported dietary quality from baseline measured via a culturally relevant checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed. Responses range from never to 2 or more times per day (responses: never, less than 1 time per month, 1 time per month, 2-3 times per month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 times per week, 1 time per day, 2 or more times per day). Calculations for nutrient intake can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient in a serving of that food and then can be compared to the American Heart Association nutrient guidelines. Better adherence of the participant's diet to the guidelines indicates better dietary quality.
measure: 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
description: Change in self reported dietary quality from baseline measured via a culturally relevant checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed. Responses range from never to 2 or more times per day (responses: never, less than 1 time per month, 1 time per month, 2-3 times per month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 times per week, 1 time per day, 2 or more times per day). Calculations for nutrient intake can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient in a serving of that food and then can be compared to the American Heart Association nutrient guidelines. Better adherence of the participant's diet to the guidelines indicates better dietary quality.
measure: 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
description: Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.
measure: 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
description: Change from baseline in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.
measure: Intervention Feasibility Measures - Participant Engagement with Tracking
time frame: Immediate post-intervention
description: Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature
measure: Intervention Feasibility Measures - Participant Engagement with Tracking
time frame: 6 months post-intervention
description: Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature
measure: Intervention Feasibility Measures - Participant Engagement with Sharing Board
time frame: Immediate post-intervention
description: Participant engagement with sharing board measured by number of posts per month by each participant
measure: Intervention Feasibility Measures - Participant Engagement with Sharing Board
time frame: 6 months post-intervention
description: Participant engagement with sharing board measured by number of posts per month by each participant
measure: Intervention Feasibility Measures - Participant Engagement with Modules
time frame: Immediate post-intervention
description: Participant engagement with education modules measured by number of modules completed out of 10
measure: Intervention Feasibility Measures - Participant Engagement with Modules
time frame: 6 months post-intervention
description: Participant engagement with education modules measured by number of modules completed out of 10
measure: Intervention Feasibility Measures - App Usability
time frame: Immediate post-intervention
description: App usability measured by Health Information Technology Usability Evaluation Scale (Health-ITUES). 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher total sum indicates higher perceived usability of the technology.
measure: Intervention Feasibility Measures - App Usability
time frame: 6 months post-intervention
description: App usability measured by Health Information Technology Usability Evaluation Scale (Health-ITUES). 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher total sum indicates higher perceived usability of the technology.
measure: Diet Self-Efficacy
time frame: Immediate post-intervention
description: Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.
measure: Diet Self-Efficacy
time frame: 6 months post-intervention
description: Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.
measure: Diet Self-Regulation
time frame: Immediate post-intervention
description: Changes from baseline 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 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.
measure: Diet Self-Regulation
time frame: 6 months post-intervention
description: Changes from baseline 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 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.
measure: Diet Social Support
time frame: Immediate post-intervention
description: Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.
measure: Diet Social Support
time frame: 6 months post-intervention
description: Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.
measure: Physical Activity Self-Efficacy
time frame: Immediate post-intervention
description: Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess 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 higher total sum indicates higher self-efficacy for physical activity.
measure: Physical Activity Self-Efficacy
time frame: 6 months post-intervention
description: Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess 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 higher total sum indicates higher self-efficacy for physical activity.
measure: Physical Activity Self-Regulation
time frame: Immediate post-intervention
description: Changes from baseline 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 five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.
measure: Physical Activity Self-Regulation
time frame: 6 months post-intervention
description: Changes from baseline 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 five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.
measure: Physical Activity Social Support
time frame: Immediate post-intervention
description: Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.
measure: Physical Activity Social Support
time frame: 6 months post-intervention
description: Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.
measure: Psychosocial Measures - Religiosity/Spirituality
time frame: 6 months post-intervention
description: Changes from baseline 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.
measure: Psychosocial Measures - Optimism
time frame: 6 months post-intervention
description: Changes from baseline 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.
measure: Psychosocial Measures - Perceived Stress
time frame: 6 months post-intervention
description: Changes from baseline 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.
arm group label: Intervention
arm group type: Experimental
description: 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.
arm group label: Delayed Intervention/Control
arm group type: No Intervention
description: The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).
intervention type: Behavioral
intervention name: FAITH! App
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: LaPrincess C Brewer
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: LaPrincess C. Brewer
investigator title: Assistant Professor of Medicine, College of Medicine
mesh term: Cardiovascular Diseases
submitted: June 5, 2023
returned: June 27, 2023
submitted: July 20, 2023
returned: August 10, 2023
submitted: September 1, 2023