The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

• ClinicalTrials.gov Identifier: NCT03777709
• Recruitment Status: Active, not recruiting
• First Posted: December 17, 2018
• Last Update Posted: March 9, 2022
• Sponsor: Mayo Clinic
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): LaPrincess C. Brewer, Mayo Clinic

Study Description

Brief Summary:

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Physical Activity; Diet Modification	Behavioral: FAITH! App	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
• Actual Study Start Date: February 1, 2020
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Delayed Intervention/Control; The delayed intervention group will not receive additional materials while under the "control" time point (intervention group within intervention/maintenance phases).

Outcome Measures

Primary Outcome Measures :

1. Life's Simple 7 Composite Score [ Time Frame: 6 months post-intervention ]
   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).
2. Blood Pressure (average of 3 sitting readings of systolic and diastolic pressures) [ Time Frame: 6 months post-intervention ]
   Change from baseline blood pressure
3. Fasting glucose (fingerstick) [ Time Frame: 6 months post-intervention ]
   Change from baseline fasting glucose
4. Fasting lipid panel [ Time Frame: 6 months post-intervention ]
   Change from baseline fasting lipid panel
5. BMI [ Time Frame: 6 months post-intervention ]
   Change from baseline BMI
6. Cigarette smoking status [ Time Frame: 6 months post-intervention ]
   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.
7. 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 ]
   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.
8. 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 ]
   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.
9. 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.
10. 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 in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.
11. 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
12. 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
13. Intervention Feasibility Measures - Participant Engagement with Sharing Board [ Time Frame: Immediate post-intervention ]
    Participant engagement with sharing board measured by number of posts per month by each participant
14. Intervention Feasibility Measures - Participant Engagement with Sharing Board [ Time Frame: 6 months post-intervention ]
    Participant engagement with sharing board measured by number of posts per month by each participant
15. Intervention Feasibility Measures - Participant Engagement with Modules [ Time Frame: Immediate post-intervention ]
    Participant engagement with education modules measured by number of modules completed out of 10
16. Intervention Feasibility Measures - Participant Engagement with Modules [ Time Frame: 6 months post-intervention ]
    Participant engagement with education modules measured by number of modules completed out of 10
17. Intervention Feasibility Measures - App Usability [ Time Frame: Immediate post-intervention ]
    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.
18. Intervention Feasibility Measures - App Usability [ Time Frame: 6 months post-intervention ]
    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.

Secondary Outcome Measures :

1. Diet Self-Efficacy [ Time Frame: Immediate post-intervention ]
   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.
2. Diet Self-Efficacy [ Time Frame: 6 months post-intervention ]
   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.
3. Diet Self-Regulation [ Time Frame: Immediate post-intervention ]
   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.
4. Diet Self-Regulation [ Time Frame: 6 months post-intervention ]
   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.
5. Diet Social Support [ Time Frame: Immediate post-intervention ]
   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.
6. Diet Social Support [ Time Frame: 6 months post-intervention ]
   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.
7. Physical Activity Self-Efficacy [ Time Frame: Immediate post-intervention ]
   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.
8. Physical Activity Self-Efficacy [ Time Frame: 6 months post-intervention ]
   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.
9. Physical Activity Self-Regulation [ Time Frame: Immediate post-intervention ]
   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.
10. Physical Activity Self-Regulation [ Time Frame: 6 months post-intervention ]
    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.
11. Physical Activity Social Support [ Time Frame: Immediate post-intervention ]
    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.
12. Physical Activity Social Support [ Time Frame: 6 months post-intervention ]
    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.
13. Psychosocial Measures - Religiosity/Spirituality [ Time Frame: 6 months post-intervention ]
    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.
14. Psychosocial Measures - Optimism [ Time Frame: 6 months post-intervention ]
    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.
15. Psychosocial Measures - Perceived Stress [ Time Frame: 6 months post-intervention ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. African American race/ethnicity
2. 18 years or older
3. Own a smart phone
4. Have basic Internet navigation skills
5. Have at least weekly Internet access (i.e. at home, church, or other public access)
6. Have an active email address
7. Intake of fruits/vegetables less than 5 servings a day
8. No engagement in regular physical activity
9. Able to engage in moderate physical activity

Exclusion criteria:

1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
2. Pregnant (due to associated hormonal and weight changes)
3. Visual/hearing impairment or mental disability that would preclude independent app use

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: LaPrincess C Brewer; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: LaPrincess C. Brewer, Assistant Professor of Medicine, College of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03777709
• Other Study ID Numbers: 18-006846; 5R21MD013490 ( U.S. NIH Grant/Contract )
• First Posted: December 17, 2018
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases