Factors Facilitating Academic-Community Research Partnerships With African American Churches: Recruitment Process for a Community-Based, Cluster Randomized Controlled Trial During the COVID-19 Pandemic.

African American (AA) churches are valuable partners in implementing health promotion programming (HPP) to combat health disparities. The study purpose was to evaluate AA church characteristics associated with enrollment into the FAITH! (Fostering African American Improvement in Total Health) Trial, a community-based, cluster randomized controlled trial (RCT) of a mobile health intervention for cardiovascular health promotion among AA churches. Churches located in Minneapolis-St. Paul and Rochester, Minnesota were invited to complete an electronic screening survey and follow-up telephone interview including the PREACH (Predicting Readiness to Engage African American Churches in Health) tool to assess church characteristics and infrastructure for HPP. The primary outcome was church enrollment in the FAITH! Trial. Key predictors included overall PREACH scores and its subscales (Personnel, Physical Structure, Faith-based Approach, Funding), congregation size, and mean congregation member age. Of the 26 churches screened, 16 (61.5%) enrolled in the trial. The enrolled churches had higher overall mean PREACH scores (36.1 vs. 30.2) and subscales for Personnel (8.8 vs. 5.6), Faith-based Approach (11.0 vs. 9.6), and Funding (7.3 vs. 4.8) compared with non-enrolled churches; all differences were not statistically significant due to small sample size. Twelve (75.0%) of the enrolled churches had >75 members versus six (60.0%) of the non-enrolled churches. Twelve (80.0%) of the enrolled churches had an average congregation member age ≤54 years versus six (67.0%) of the non-enrolled churches. AA churches enrolling into a community-based RCT reported greater infrastructure for HPP, larger congregations, and members of younger age. These characteristics may be helpful to consider among researchers partnering with AA churches for HPP studies.

The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial.

BACKGROUND: Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials. OBJECTIVE: The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2. METHODS: All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal). RESULTS: Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001). CONCLUSIONS: There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools. TRIAL REGISTRATION: Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.

Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial.

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.

Trends in Stress Throughout Pregnancy and Postpartum Period During the COVID-19 Pandemic: Longitudinal Study Using Ecological Momentary Assessment and Data From the Postpartum Mothers Mobile Study.

BACKGROUND: Stress is associated with adverse birth and postpartum health outcomes. Few studies have longitudinally explored racial differences in maternal stress in a birthing population in the United States during the ongoing COVID-19 pandemic. OBJECTIVE: This study aimed to do the following: (1) assess changes in reported stress before, during, and after initial emergency declarations (eg, stay-at-home orders) were in place due to the COVID-19 pandemic, and (2) assess Black-White differences in reported stress in a pregnant and postpartum population from Southwestern Pennsylvania. METHODS: We leveraged data from the ongoing Postpartum Mothers Mobile Study (PMOMS), which surveys participants in real time throughout the pregnancy and postpartum periods via ecological momentary assessment (EMA) and smartphone technology. We analyzed data from a subset of PMOMS participants (n=85) who were either Black or White, and who submitted EMA responses regarding stress between November 1, 2019, and August 31, 2020, the time frame of this study. We divided data into four phases based on significant events during the COVID-19 pandemic: "pre" phase (baseline), "early" phase (first case of COVID-19 reported in United States), "during" phase (stay-at-home orders), and "post" phase (stay-at-home orders eased). We assessed mean stress levels at each phase using linear mixed-effects models and post hoc contrasts based on the models. RESULTS: Overall mean stress (0=not at all to 4=a lot) during the pre phase was 0.8 for Black and White participants (range for Black participants: 0-3.9; range for White participants: 0-2.8). There was an increase of 0.3 points (t5649=5.2, P<.001) in the during phase as compared with the pre phase, and an increase of 0.2 points (t5649=3.1, P=.002) in the post phase compared with the pre phase (n=85). No difference was found between Black and White participants in the change in mean stress from the pre phase to the during phase (overall change predicted for the regression coefficient=-0.02, P=.87). There was a significant difference between Black and White participants in the change in mean stress from the during phase to the post phase (overall change predicted for the regression coefficient=0.4, P<.001). CONCLUSIONS: There was an overall increase in mean stress levels in this subset of pregnant and postpartum participants during the same time as the emergency declarations/stay-at-home orders in the United States. Compared to baseline, mean stress levels remained elevated when stay-at-home orders eased. We found no significant difference in the mean stress levels by race. Given that stress is associated with adverse birth outcomes and postpartum health, stress induced by the ongoing COVID-19 pandemic may have adverse implications for birthing populations in the United States. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13569.