TY - JOUR
T1 - Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention
T2 - Rationale, design, and baseline findings of the FAITH! Trial
AU - Brewer, La Princess C.
AU - Jenkins, Sarah
AU - Hayes, Sharonne N.
AU - Kumbamu, Ashok
AU - Jones, Clarence
AU - Burke, Lora E.
AU - Cooper, Lisa A.
AU - Patten, Christi A.
N1 - Funding Information:
We employed a pilot cluster, RCT with delayed intervention control group which is consistent with the overarching CBPR process. The study was reviewed and approved by the Mayo Clinic Institutional Review Board and registered (clinicaltrials.gov NCT03777709 ). Written informed consent was obtained from all individuals prior to participation. This study was directly funded by the National Institutes of Health (NIH)/National Institute on Minority Health and Health Disparities (NIMHD) (Grant No. 1 R21 MD013490-01), the American Heart Association-Amos Medical Faculty Development Program (Grant No. 19AMFDP35040005), the Clinical and Translational Science Awards (CTSA) (Grant No. UL1 TR000135) from the National Center for Advancing Translational Sciences (NCATS) and the Mayo Clinic Center for Health Equity and Community Engagement in Research. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.
Funding Information:
The research reported herein was supported by the National Institutes of Health (NIH)/National Institute on Minority Health and Health Disparities (NIMHD) (Grant No. 1 R21 MD013490-01 ), the Clinical and Translational Science Awards (CTSA) ( Grant No. UL1 TR000135) from the National Center for Advancing Translational Sciences (NCATS) to Mayo Clinic and the Mayo Clinic Center for Health Equity and Community Engagement in Research. Dr. Brewer was supported by the American Heart Association-Amos Medical Faculty Development Program ( Grant No. 19AMFDP35040005 ), NCATS (CTSA Grant No. KL2 TR002379 ) and the Centers for Disease Control and Prevention (CDC , Grant No. CDC-DP18-1817 ) during the implementation of this work. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCATS, NIH or CDC. The funding bodies had no role in study design; in the collection, analysis, and interpretation of data; writing of the manuscript; and in the decision to submit the manuscript for publication.
Publisher Copyright:
© 2022
PY - 2022/5
Y1 - 2022/5
N2 - Background: Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned. Methods: Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability. Results: Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9). Conclusions: The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.
AB - Background: Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned. Methods: Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability. Results: Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9). Conclusions: The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.
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U2 - 10.1016/j.ahj.2022.01.009
DO - 10.1016/j.ahj.2022.01.009
M3 - Article
C2 - 35065922
AN - SCOPUS:85125782010
SN - 0002-8703
VL - 247
SP - 1
EP - 14
JO - American Heart Journal
JF - American Heart Journal
ER -