N/A
Completed N=85
The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans
Cardiovascular Disease · Physical Activity · Diet Modification · Lifestyle Factors
Source: ClinicalTrials.gov NCT03777709 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Life's Simple 7 Composite Score Change — 1.88; 0.74 units on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Life's Simple 7 Composite Score Change |
1.88; 0.74 | <0.0001 sig |
| PRIMARY Blood Pressure Change |
-3.09; -7.25; -0.53; -2.5 | — |
| PRIMARY Fasting Glucose (Fingerstick) |
2.89; 6.73 | — |
| PRIMARY Fasting Lipid Panel |
-10.96; -17.74 | — |
| PRIMARY BMI |
-0.16; 0.14 | — |
| PRIMARY Smoking Status Category |
0; 1; 1; 0; 1; 0 | — |
| PRIMARY Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ) |
0.79; -0.08 | — |
| PRIMARY Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ) |
219.70; 76.09 | — |
| PRIMARY Intervention Feasibility Measures - Participant Engagement With Tracking |
23; 23 | — |
| PRIMARY Number of Participants With and Without Engagement With Sharing Board |
26; 4 | — |
| PRIMARY Intervention Feasibility Measures - Participant Engagement With Sharing Board |
5; 10 | — |
| PRIMARY Intervention Feasibility Measures - Participant Engagement With Modules |
21; 21; 13; 21 | — |
| PRIMARY Intervention Feasibility Measures - App Usability |
4.2; 4.1; 4.6; 4.2; 4.4; 4.1 | — |
| SECONDARY Smoking at Baseline as Assessed by Cigarette Smoking Status |
33; 40; 1; 1; 0; 1 | — |
| SECONDARY Diet Self-Efficacy |
0.86; -5.30 | — |
| SECONDARY Diet Self-Regulation |
0.43; 0.34; 0.31; 0.18; 0.68; 0.02 | — |
| SECONDARY Diet Social Support |
1.33; 0.21; 0.28; 2.28; 0.50; 0.53 | — |
| SECONDARY Physical Activity Self-Efficacy |
-0.12; -0.10; -0.39; 0.00 | — |
| SECONDARY Physical Activity Self-Regulation |
0.56; 0.20 | — |
| SECONDARY Physical Activity Social Support |
3.12; -0.45; 0.15; 0.28; 3.92; 1.61 | — |
| SECONDARY Psychosocial Measures - Religiosity/Spirituality |
0.07; 0.14 | — |
| SECONDARY Psychosocial Measures - Optimism |
0.23; -0.26 | — |
| SECONDARY Psychosocial Measures - Perceived Stress |
-0.08; -0.61 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Intake of fruits/vegetables less than 5 servings a day
- No engagement in regular physical activity
- Able to engage in moderate physical activity
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03777709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.