Lifestyle practices and associated factors among adults with hypertension: Conquering Hypertension in Vietnam-solutions at the grassroots level study.

BACKGROUND: Vietnam is experiencing an increasing prevalence of hypertension in its adult population. In addition to medical therapy, modifying adverse lifestyle practices is important for effective blood pressure control. There are limited data on unhealthy lifestyle practices in patients with chronic diseases, however, particularly among hypertensive patients living in rural Vietnam. Our study objectives were to examine the prevalence of unhealthy lifestyle practices and associated factors among rural Vietnamese adults with uncontrolled hypertension. METHODS: Data from the baseline survey of a cluster randomized trial among hypertensive Vietnamese adults (2017-2022) were utilized. Information on unhealthy lifestyle practices including smoking, excessive alcohol consumption, physical inactivity, and inadequate fruit and vegetable intake was collected from study participants. The primary study outcome was having ≥2 unhealthy lifestyle practices. A multivariable logistic regression model was used to examine factors associated with the primary study outcome. RESULTS: The mean age of the 671 patients was 67 years and 45.0% were men. Nearly three out of every four participants had one or fewer unhealthy practices, 24.0% had two, and 3.3% had three or all four unhealthy lifestyle practices. Men, individuals who did unpaid work or were unemployed, and individuals with hypertension level III were more likely to have ≥2 unhealthy lifestyle practices, whereas individuals with higher education were less likely to have ≥2 unhealthy lifestyle practices compared with respective comparison groups. CONCLUSIONS: We observed a high prevalence of unhealthy lifestyle practices among rural Vietnamese patients with uncontrolled hypertension. Several demographic factors were associated with a greater number of unhealthy lifestyle practices. Newer interventions and educational programs encouraging lifestyle modification practices are needed to control hypertension among adults living in rural settings of Vietnam.

Cost-utility analysis of community-based interventions for hypertension control in Vietnam.

Between 2010 and 2011, stakeholders implemented a multi-faceted community-based intervention in response to the escalating issue of uncontrolled hypertension in Hung Yen province, Vietnam. This initiative integrated expanded community health worker services, home blood pressure self-monitoring, and a unique "storytelling intervention" into routine clinical care. From the limited societal perspective, our study evaluates the cost-effectiveness of this intervention using a Markov model with a one-year cycle over a lifetime horizon. The analysis, based on a cohort of 671 patients, reveals a lifetime incremental cost of approximately VND 90.37 million (USD 3,930) per quality-adjusted life year (QALY) gained. With a willingness to pay at three times GDP (VND 259.2 million per QALY), the intervention proves cost-effective 80% of the time. This research underscores the potential of the community-based approach to effectively control hypertension, offering valuable insights into its broader implications for public health.

Peer Texting to Promote Quitline Use and Smoking Cessation Among Rural Participants in Vietnam: Randomized Clinical Trial.

Objectives: We tested an adapted version of an effective U.S.-based peer-texting intervention to promote Quitline use and smoking cessation among rural participants in Vietnam. Methods: We conducted a two-arm randomized trial with participants recruited at four rural community centers. The intervention included peer messages sent for six months that promoted Quitline use and smoking cessation. Additionally, biweekly two-way text messages assessed participants' interest in Quitline referral and current smoking status. Comparison participants received only the bi-weekly text message assessment of their current smoking status. At six months, we assessed Quitline use and smoking cessation. Smoking cessation was assessed using the 7-day point prevalence question and verified with a carbon monoxide breath monitor (<=6 ppm). Results: Among 750 participants, the intervention had higher Quitline verified use (18%, 95% CI 0.14, 0.22) than comparison (1%, 95% CI .2, 2, p < 0.0001). Carbon-monoxide-verified smoking cessation did not differ between the two groups. However, intervention (28.3%, 95% CI) and comparison (28.1%, 95% CI) participants had substantial rates of carbon monoxide cessation at 6 months (both 28%). Conclusion: Our study highlighted the promise of texting interventions to extend tobacco control efforts in Vietnam.

Examining racial/ethnic inequities in treatment participation among perinatal individuals with depression.

OBJECTIVE: A cluster randomized controlled trial (RCT) of two interventions for addressing perinatal depression treatment in obstetric settings was conducted. This secondary analysis compared treatment referral and participation among Minoritized perinatal individuals compared to their non-Hispanic white counterparts. METHODS: Among perinatal individuals with depression symptoms, we examined rates of treatment 1) referral (i.e., offered medications or referred to mental health clinician), 2) initiation (i.e., attended ≥1 mental health visit or reported prescribed antidepressant medication), and 3) sustainment (i.e., attended >1 mental health visit per study month or prescribed antidepressant medication at time of study interviews). We compared non-Hispanic white (NHW) (n = 149) vs. Minoritized perinatal individuals (Black, Asian, Hispanic/Latina, Pacific Islander, Native American, Multiracial, and white Hispanic/Latina n = 157). We calculated adjusted odds ratios (aOR) for each outcome. RESULTS: Minoritized perinatal individuals across both interventions had significantly lower odds of treatment referral (aOR = 0.48;95% CI = 0.27-0.88) than their NHW counterparts. There were no statistically significant differences in the odds of treatment initiation (aOR = 0.64 95% CI:0.36-1.2) or sustainment (aOR = 0.54;95% CI = 0.28-1.1) by race/ethnicity. CONCLUSIONS: Perinatal mental healthcare inequities are associated with disparities in treatment referrals. Interventions focusing on referral disparities across race and ethnicity are needed.

Examining Race-Based and Gender-Based Discrimination, Trust in Providers, and Mental Well-Being Among Black Women.

OBJECTIVES: To examine experiences of discrimination among Black women, and to determine if experiencing race- and gender-based discrimination is associated with mental well-being and trust. METHODS: Data from the TRUST study were used to examine experiences of discrimination among 559 Black women with hypertension receiving healthcare at a safety-net hospital in Birmingham, Alabama. A three-level variable was constructed to combine the race-based and gender-based measures of the Experiences of Discrimination scale. Linear regression was used to examine the association between experiences of discrimination with mental well-being and trust. RESULTS: Women who reported no experiences of race- or gender-based discrimination were older and reported higher mental well-being scores and greater trust. Fifty-three percent of study participants reported experiencing discrimination. Compared to participants who did not experience race- or gender-based discrimination, participants reporting experiences of race- or gender-based discrimination and those reporting experiencing both race- and gender-based discrimination were more likely to report poorer mental health. CONCLUSION: Reported experiences of gender- and/or race-based discrimination in this study were associated with lower mental health scores and less trust in health care providers. Our findings highlight the importance of examining experiences of discrimination among Black women, and the role of discrimination as a stressor and in reducing trust for providers. Incorporating an understanding and acknowledgement of experiences of discrimination into interventions, programs, and during clinical encounters may foster more trusting relationships between providers and patients.

Paying for Medical and Social Complexity in Massachusetts Medicaid.

Importance: The first MassHealth Social Determinants of Health payment model boosted payments for groups with unstable housing and those living in socioeconomically stressed neighborhoods. Improvements were designed to address previously mispriced subgroups and promote equitable payments to MassHealth accountable care organizations (ACOs). Objective: To develop a model that ensures payments largely follow observed costs for members with complex health and/or social risks. Design, Setting, and Participants: This cross sectional study used administrative data for members of the Massachusetts Medicaid program MassHealth in 2016 or 2017. Participants included members who were eligible for MassHealth's managed care, aged 0 to 64 years, and enrolled for at least 183 days in 2017. A new total cost of care model was developed and its performance compared with 2 earlier models. All models were fit to 2017 data (most recent available) and validated on 2016 data. Analyses were begun in February 2019 and completed in January 2023. Exposures: Model 1 used age-sex categories, a diagnosis-based morbidity relative risk score (RRS), disability, serious mental illness, substance use disorder, housing problems, and neighborhood stress. Model 2 added an interaction for unstable housing with RRS. Model 3 added rurality and updated diagnosis-based RRS, medication-based RRS, and interactions between sociodemographic characteristics and morbidity. Main Outcome and Measures: Total 2017 annual cost was modeled and overall model performance (R2) and fair pricing of subgroups evaluated using observed-to-expected (O:E) ratios. Results: Among 1 323 424 members, mean (SD) age was 26.4 (17.9) years, 53.4% were female (46.6% male), and mean (SD) 2017 cost was $5862 ($15 417). The R2 for models 1, 2, and 3 was 52.1%, 51.5%, and 60.3%, respectively. Earlier models overestimated costs for members without behavioral health conditions (O:E ratios 0.94 and 0.93 for models 1 and 2, respectively) and underestimated costs for those with behavioral health conditions (O:E ratio >1.10); model 3 O:E ratios were near 1.00. Model 3 was better calibrated for members with housing problems, those with children, and those with high morbidity scores. It reduced underpayments to ACOs whose members had high medical and social complexity. Absolute and relative model performance were similar in 2016 data. Conclusions and Relevance: In this cross-sectional study of data from Massachusetts Medicaid, careful modeling of social and medical risk improved model performance and mitigated underpayments to safety-net systems.

A multi-step approach to develop a "storytelling" intervention to improve patient gout knowledge and improve outpatient follow-up.

Background: "Storytelling" interventions influence knowledge, attitudes and behavior to promote chronic disease management. We aimed to describe the development of a video "storytelling" intervention to increase gout knowledge and promote adherence to medications and follow-up care after an acute gout flare visit in the emergency department. Methods: We developed a direct-to-patient storytelling intervention to mitigate modifiable barriers to gout care and promote outpatient follow-up and medication adherence. We invited adult patients with gout as storytellers. We utilized a modified Delphi process involving gout experts to identify key themes to guide development of an intervention. Using a conceptual model, we selected stories to ensure delivery of evidence-based concepts and to maintain authenticity. Results: Our video-based storytelling intervention consisted of segments addressing modifiable barriers to gout care. Four diverse gout patients were recruited as storytellers and interviewed with questions that covered gout diagnosis and care. Eleven international gout experts from diverse geographic locations generated and ranked items they considered important messages to promote outpatient gout care follow-up and treatment adherence. Filmed videos were truncated into segments and coded thematically. Distinct segments that captured desired messages were combined to form a cohesive narrative story based on gout patient experiences that conveyed evidence-based strategies to manage gout. Conclusions: Using the Health Belief Model, we developed a culturally appropriate narrative intervention containing "storytelling" that can be tested as an approach to improve gout outcomes. The methods we describe may be generalizable to other chronic conditions requiring outpatient follow-up and medication adherence to improve outcomes.

Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial.

Importance: Novel data science and marketing methods of smoking-cessation intervention have not been adequately evaluated. Objective: To compare machine learning recommender (ML recommender) computer tailoring of motivational text messages vs a standard motivational text-based intervention (standard messaging) and a viral peer-recruitment tool kit (viral tool kit) for recruiting friends and family vs no tool kit in a smoking-cessation intervention. Design, Setting, and Participants: This 2 ×2 factorial randomized clinical trial with partial allocation, conducted between July 2017 and September 2019 within an online tobacco intervention, recruited current smokers aged 18 years and older who spoke English from the US via the internet and peer referral. Data were analyzed from March through May 2022. Interventions: Participants registering for the online intervention were randomly assigned to the ML recommender or standard messaging groups followed by partially random allocation to access to viral tool kit or no viral tool kit groups. The ML recommender provided ongoing refinement of message selection based on user feedback and comparison with a growing database of other users, while the standard system selected messages based on participant baseline readiness to quit. Main Outcomes and Measures: Our primary outcome was self-reported 7-day point prevalence smoking cessation at 6 months. Results: Of 1487 participants who smoked (444 aged 19-34 years [29.9%], 508 aged 35-54 years [34.1%], 535 aged ≥55 years [36.0%]; 1101 [74.0%] females; 189 Black [12.7%] and 1101 White [78.5%]; 106 Hispanic [7.1%]), 741 individuals were randomly assigned to the ML recommender group and 746 individuals to the standard messaging group; viral tool kit access was provided to 745 participants, and 742 participants received no such access. There was no significant difference in 6-month smoking cessation between ML recommender (146 of 412 participants [35.4%] with outcome data) and standard messaging (156 of 389 participants [40.1%] with outcome data) groups (adjusted odds ratio, 0.81; 95% CI, 0.61-1.08). Smoking cessation was significantly higher in viral tool kit (177 of 395 participants [44.8%] with outcome data) vs no viral tool kit (125 of 406 participants [30.8%] with outcome data) groups (adjusted odds ratio, 1.48; 95% CI, 1.11-1.98). Conclusions and Relevance: In this study, machine learning-based selection did not improve performance compared with standard message selection, while viral marketing did improve cessation outcomes. These results suggest that in addition to increasing dissemination, viral recruitment may have important implications for improving effectiveness of smoking-cessation interventions. Trial Registration: ClinicalTrials.gov Identifier: NCT03224520.

A review of harmonization methods for studying dietary patterns.

Data harmonization is the process by which each of the variables from different research studies are standardized to similar units resulting in comparable datasets. These data may be integrated for more powerful and accurate examination and prediction of outcomes for use in the intelligent and smart electronic health software programs and systems. Prospective harmonization is performed when researchers create guidelines for gathering and managing the data before data collection begins. In contrast, retrospective harmonization is performed by pooling previously collected data from various studies using expert domain knowledge to identify and translate variables. In nutritional epidemiology, dietary data harmonization is often necessary to construct the nutrient and food databases necessary to answer complex research questions and develop effective public health policy. In this paper, we review methods for effective data harmonization, including developing a harmonization plan, which common standards already exist for harmonization, and defining variables needed to harmonize datasets. Currently, several large-scale studies maintain harmonized nutrient databases, especially in Europe, and steps have been proposed to inform the retrospective harmonization process. As an example, data harmonization methods are applied to several U.S longitudinal diet datasets. Based on our review, considerations for future dietary data harmonization include user agreements for sharing private data among participating studies, defining variables and data dictionaries that accurately map variables among studies, and the use of secure data storage servers to maintain privacy. These considerations establish necessary components of harmonized data for smart health applications which can promote healthier eating and provide greater insights into the effect of dietary patterns on health.

Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit: A Randomized Clinical Trial.

IMPORTANCE: Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging. OBJECTIVE: To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. DESIGN, SETTING, AND PARTICIPANTS: A multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020. INTERVENTIONS: Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only. MAIN OUTCOMES AND MEASURES: Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level-verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. RESULTS: Of the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (χ2 test, P = .045) participants obtained carbon monoxide level-verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial demonstrate that individuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02973425.

Examining medication adherence and preferences for a lifestyle intervention among Black and Latinx adults with hypertension: a feasibility study.

BACKGROUND: Approximately 116.4 million adults in the USA have hypertension, and the rates of uncontrolled hypertension remain higher among racial and ethnic minorities. There is a need for effective interventions that promote healthy behaviors and long-term behavioral change in the management of hypertension. The primary objective of this study was to determine the feasibility of developing a lifestyle intervention that would assess hypertension management and the use of technology among Blacks and Latinx with hypertension. The secondary objective is to explore perceptions of community-based resources for hypertension and preferences for a lifestyle intervention for hypertension among Blacks and Latinx with hypertension. METHODS: In this explanatory mixed-methods study, quantitative data were collected using surveys, participants reported their use of technology and adherence to antihypertensive medication. Participants were Black and Latinx adults with hypertension living in Central Pennsylvania, USA. Qualitative data were obtained from semi-structured interviews and focus groups, and participants were asked about managing hypertension, local resources, and preferences for a behavioral intervention. Data were examined using summary statistics for quantitative data and thematic analysis for qualitative data. RESULTS: Black and Latinx participants (n=30) completed surveys for the quantitative study. The majority (75%) of participants self-reported being confident in managing their medication without help and remembering to take their medication as prescribed. Fewer participants (54.2%) reported using technology to help manage medication. There were 12 participants in the qualitative phase of the study. The qualitative findings indicated that participants felt confident in their ability to manage hypertension and were interested in participating in a lifestyle intervention or program based online. Some participants reported a lack of resources in their community, while others highlighted local and national resources that were helpful in managing high blood pressure. CONCLUSION: This study provides important insights on barriers and facilitators for managing hypertension, current use of technology and interest in using technology to manage hypertension, and preferences for future lifestyle interventions among racial and ethnic minorities. This study also provides insights to the health needs and resources available in this community and how future behavioral interventions could be tailored to meet the needs of this community. The findings of this study will be used to inform the tailoring of future lifestyle interventions; specifically, we will include text messaging reminders for medication and to disseminate educational materials related to hypertension and provide resources to connect study participants with local and national resources.

mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam.

BACKGROUND: Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE: The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS: We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS: Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS: This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30947.

Early childhood undernutrition, preadolescent physical growth, and cognitive achievement in India: A population-based cohort study.

BACKGROUND: There is a lack of nationally representative estimates for the consequences of early childhood undernutrition on preadolescent outcomes in India. Understanding this relationship is helpful to develop interventions that not only prevent child undernutrition but also mitigate its consequences. METHODS AND FINDINGS: In this cohort study, we analyzed prospectively gathered data from 2 waves of the India Human Development Survey (IHDS) to investigate the association of undernutrition during early childhood (0 to 5 years) in 2004 to 2005 with physical and cognitive outcomes during preadolescent (8 to 11 years) years in 2011 to 2012. These surveys interviewed 41,554 households across all 33 states and union territories in India in 2004 to 2005 and reinterviewed 83% of the households in 2011 to 2012. Primary exposure was assessed using the Composite Index of Anthropometric Failure (CIAF) based on 2004 to 2005 survey. Primary outcomes were short stature (height-for-age z-score [HAZ] <-2), thinness (body mass index [BMI] <18.5 kg/m2), reading, and arithmetic skills during preadolescence based on the 2011 to 2012 survey. Survey-weighted generalized linear models were used, and effect modification based on child sex and sociodemographic variables were evaluated using 3-way interaction terms. Of the 7,868 children included in this analysis, 4,334 (57.3%) were undernourished. Being undernourished was associated with increased odds of short stature (odds ratio [OR] 1.73, 95% confidence interval [CI] 1.45 to 2.06) and thinness (OR 1.52, 95% CI 1.33 to 1.73) during the preadolescent period, while it was associated with decreased odds of achieving a higher reading (cumulative odds ratio [cumOR]: 0.76, 0.66 to 0.87) and arithmetic (cumOR: 0.72, 0.63 to 0.82) outcomes. The disparity in outcomes based on CIAF increased with age, especially for female children. Increased level of female education within the household reduced the disadvantages of undernutrition among female children. Study limitations include observational and missing data, which limit our ability to draw strong causal inferences. CONCLUSIONS: In this study, we found that early child undernutrition was associated with several adverse preadolescent physical and cognitive outcomes, especially among female children. Improved female education mitigates this association. Female education promotion should assume a central role in Indian public health policy making.

Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement.

BACKGROUND: Motivational messaging is a frequently used digital intervention to promote positive health behavior changes, including smoking cessation. Typically, motivational messaging systems have not actively sought feedback on each message, preventing a closer examination of the user-system engagement. This study assessed the granular user-system engagement around a recommender system (a new system that actively sought user feedback on each message to improve message selection) for promoting smoking cessation and the impact of engagement on cessation outcome. METHODS: We prospectively followed a cohort of current smokers enrolled to use the recommender system for 6 months. The system sent participants motivational messages to support smoking cessation every 3 days and used machine learning to incorporate user feedback (i.e., user's rating on the perceived influence of each message, collected on a 5-point Likert scale with 1 indicating strong disagreement and 5 indicating strong agreement on perceiving the influence on quitting smoking) to improve the selection of the following message. We assessed user-system engagement by various metrics, including user response rate (i.e., the percent of times a user rated the messages) and the perceived influence of messages. We compared retention rates across different levels of user-system engagement and assessed the association between engagement and the 7-day point prevalence abstinence (missing outcome = smoking) by using multiple logistic regression. RESULTS: We analyzed data from 731 participants (13% Black; 73% women). The user response rate was 0.24 (SD = 0.34) and user-perceived influence was 3.76 (SD = 0.84). The retention rate positively increased with the user response rate (trend test P < 0.001). Compared with non-response, six-month cessation increased with the levels of response rates: low response rate (odds ratio [OR] = 1.86, 95% confidence interval [CI]: 1.07-3.23), moderate response rate (OR = 2.30, 95% CI: 1.36-3.88), high response rate (OR = 2.69, 95% CI: 1.58-4.58). The association between perceived message influence and the outcome showed a similar pattern. CONCLUSIONS: High user-system engagement was positively associated with both high retention rate and smoking cessation, suggesting that investigation of methods to increase engagement may be crucial to increase the impact of the recommender system for smoking cessation. TRIAL REGISTRATION: Registration Identifier: NCT03224520 . Registration date: July 21, 2017.

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.

INTRODUCTION: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. METHODS: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. RESULTS: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. CONCLUSIONS: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam.

BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).

Supports for Maternal Communication About Peer Pressure to Have Sex Among Puerto Rican Families.

This research tests the independent contribution of social capital and the use of the internet to obtain health information to support maternal-child communication about peer pressure to have sex among Puerto Rican families. A sample of 413 Puerto Rican households in Springfield, MA provides the data to independently test these hypotheses. The results of a logistic regression model suggest that Puerto Rican mothers with increased social capital and who accessed the internet for health information are more likely to communicate with their adolescent children about peer pressure to have sex. The combination of these two mechanisms provide opportunities to convey culturally generated resources to Puerto Rican mothers to assist them in helping their children develop healthy sexual behaviors.

Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov.

BACKGROUND: Choosing the right recruitment strategy has implications for the successful conduct of a trial. Our objective was to compare a novel peer recruitment strategy to four other recruitment strategies for a large randomized trial testing a digital tobacco intervention. METHODS: We compared enrollment rates, demographic and baseline smoking characteristics, and odds of completing the 6-month study by recruitment strategy. Cost of recruitment strategies per retained participant was calculated using staff personnel time and advertisement costs. FINDINGS: We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n = 273 (18.4%), Facebook Ads n = 505 (34%), Google Ads = 200 (13.4%), ResearchMatch n = 356 (23.9%) and Smokefree.govn = 153 (10.3%). Mean enrollment rate per active recruitment month: 1) Peer recruitment, n = 13.9, 2) Facebook ads, n = 25.3, 3) Google ads, n = 10.51, 4) Research Match, n = 59.3, and 5) Smokefree.gov, n = 13.9. Peer recruitment recruited the greatest number of males (n = 110, 40.3%), young adults (n = 41, 14.7%), participants with a high school degree or less (n = 24, 12.5%) and smokers within one's social network. Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%). Peer recruitment was moderate in cost per retained participant ($47.18) and substantially less costly than Facebook ($173.60). CONCLUSIONS: Though peer recruitment had lower enrollment than other strategies, it may provide greater access to harder to reach populations and possibly others who smoke within one's social network while being moderately cost-effective. ClinicalTrials.gov: NCT03224520.

Complex Patients Have More Emergency Visits: Don't Punish the Systems That Serve Them.

IMPORTANCE: Better patient management can reduce emergency department (ED) use. Performance measures should reward plans for reducing utilization by predictably high-use patients, rather than rewarding plans that shun them. OBJECTIVE: The objective of this study was to develop a quality measure for ED use for people diagnosed with serious mental illness or substance use disorder, accounting for both medical and social determinants of health (SDH) risks. DESIGN: Regression modeling to predict ED use rates using diagnosis-based and SDH-augmented models, to compare accuracy overall and for vulnerable populations. SETTING: MassHealth, Massachusetts' Medicaid and Children's Health Insurance Program. PARTICIPANTS: MassHealth members ages 18-64, continuously enrolled for the calendar year 2016, with a diagnosis of serious mental illness or substance use disorder. EXPOSURES: Diagnosis-based model predictors are diagnoses from medical encounters, age, and sex. Additional SDH predictors describe housing problems, behavioral health issues, disability, and neighborhood-level stress. MAIN OUTCOME AND MEASURES: We predicted ED use rates: (1) using age/sex and distinguishing between single or dual diagnoses; (2) adding summarized medical risk (DxCG); and (3) further adding social risk (SDH). RESULTS: Among 144,981 study subjects, 57% were women, 25% dually diagnosed, 67% White/non-Hispanic, 18% unstably housed, and 37% disabled. Utilization was higher by 77% for those dually diagnosed, 50% for members with housing problems, and 18% for members living in the highest-stress neighborhoods. SDH modeling predicted best for these high-use populations and was most accurate for plans with complex patients. CONCLUSION: To set appropriate benchmarks for comparing health plans, quality measures for ED visits should be adjusted for both medical and social risks.

Keeping weight off: Mindfulness-Based Stress Reduction alters amygdala functional connectivity during weight loss maintenance in a randomized control trial.

Obesity is associated with significant comorbidities and financial costs. While behavioral interventions produce clinically meaningful weight loss, weight loss maintenance is challenging. The objective was to improve understanding of the neural and psychological mechanisms modified by mindfulness that may predict clinical outcomes. Individuals who intentionally recently lost weight were randomized to Mindfulness-Based Stress Reduction (MBSR) or a control healthy living course. Anthropometric and psychological factors were measured at baseline, 8 weeks and 6 months. Functional connectivity (FC) analysis was performed at baseline and 8 weeks to examine FC changes between regions of interest selected a priori, and independent components identified by independent component analysis. The association of pre-post FC changes with 6-month weight and psychometric outcomes was then analyzed. Significant group x time interaction was found for FC between the amygdala and ventromedial prefrontal cortex, such that FC increased in the MBSR group and decreased in controls. Non-significant changes in weight were observed at 6 months, where the mindfulness group maintained their weight while the controls showed a weight increase of 3.4% in BMI. Change in FC at 8-weeks between ventromedial prefrontal cortex and several ROIs was associated with change in depression symptoms but not weight at 6 months. This pilot study provides preliminary evidence of neural mechanisms that may be involved in MBSR's impact on weight loss maintenance that may be useful for designing future clinical trials and mechanistic studies.