Clinical trial NCT03777709: The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
Official title: The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Physical Activity
Diet Modification
Lifestyle Factors
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-12-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Life's Simple 7 Composite Score Change
timeFrame: 6 months post-intervention
measure: Blood Pressure Change
timeFrame: 6 months post-intervention
measure: Fasting Glucose (Fingerstick)
timeFrame: 6 months post-intervention
measure: Fasting Lipid Panel
timeFrame: 6 months post-intervention
measure: BMI
timeFrame: 6 months post-intervention
measure: Smoking Status Category
timeFrame: Baseline
measure: Smoking Status Category
timeFrame: 6 Months post-intervention
measure: Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
timeFrame: Immediate post-intervention
measure: Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)
timeFrame: 6 months post-intervention
measure: Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
timeFrame: Immediate post-intervention
measure: Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)
timeFrame: 6 months post-intervention
measure: Intervention Feasibility Measures - Participant Engagement With Tracking
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - Participant Engagement With Tracking
timeFrame: 6 months post-intervention
measure: Number of Participants With and Without Engagement With Sharing Board
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - Participant Engagement With Sharing Board
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - Participant Engagement With Modules
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - App Usability
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Smoking at Baseline as Assessed by Cigarette Smoking Status
timeFrame: Day 1
measure: Diet Self-Efficacy
timeFrame: 6 months post-intervention
measure: Diet Self-Regulation
timeFrame: 6 months post-intervention
measure: Diet Social Support
timeFrame: 6 months post-intervention
measure: Physical Activity Self-Efficacy
timeFrame: 6 months post-intervention
measure: Physical Activity Self-Regulation
timeFrame: 6 months post-intervention
measure: Physical Activity Social Support
timeFrame: 6 months post-intervention
measure: Psychosocial Measures - Religiosity/Spirituality
timeFrame: 6 months post-intervention
measure: Psychosocial Measures - Optimism
timeFrame: 6 months post-intervention
measure: Psychosocial Measures - Perceived Stress
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess C Brewer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.