Background: Although teen pregnancy rates decreased dramatically in the United States over the past decade, the rates of sexually transmitted infections (STIs) among adolescents and young adults increased. STI rates disproportionately affect African American youth and young adults. Innovative, accessible, and culturally relevant sexual health interventions are urgently needed. Objective: This study aimed to identify the optimal modality for a game-based sexual health intervention; develop the educational, entertainment, and technological aspects of the serious game; and demonstrate its usability and acceptance by the target population. Methods: This project was grounded in formative data collection with community-based participatory research principles and practices combined with a user-centered design and development approach. Sexually Active Adolescent–Focused Education (SAAFE) was developed using input and feedback from African American youths aged 15 to 21 years who participated in a youth advisory board and focus group discussions to inform the co-design and cocreation of the serious game. The process was highly iterative with multiple sessions for user input following design changes. It proceeded in 3 stages. Social cognitive theory and problem-solving theory were leveraged to provide evidence-based, trauma-informed education through a serious game. Usability testing assessed the quality of user experience with the prototype. Results: Across all 3 stages, a total of 86 self-identified African American males and females aged 15 to 21 years from the District of Columbia and Birmingham, Alabama, participated. Participants requested a dating simulation game. They wanted SAAFE to be customizable, realistic, entertaining, educational, modern, and experiential, linking consequences to their gameplay decisions. Usability testing resulted in an initial System Usability Survey score of 77.7, placing the game in the 82nd percentile and above average for usability. Conclusions: Initial results suggest that the SAAFE prototype is a promising intervention to engage African American youth in sexual health education using a role-playing game. If proven efficacious, the game has the potential to meet the need for sex education, counterbalance unhealthy portrayals of sex in popular media, and respond to the disparities in the STI epidemic.

The study aim was to implement and evaluate the feasibility of a culturally informed (“BeFAB”) app for African American/Black women to address postpartum weight. Women (n = 136; mean age = 27.8 ± 5.4; mean BMI = 32.5 ± 4.3) were recruited from postpartum units, and randomly assigned to receive BeFAB (n = 65) or usual care (n = 71) for 12 weeks. App content included didactic lessons delivered via a virtual coach, app-based messages, goal setting and tracking, and edutainment videos. Feasibility outcomes included recruitment, retention and engagement, and self-reported acceptability. Behavioral (i.e., diet, physical activity), psychosocial (i.e., stress, coping, support, self-efficacy) and weight outcomes were also examined. Recruitment goals were met, but attrition was high, with 56% retention at 12 weeks. Approximately half of participants accessed the app and set a goal ≥one time, but <10% reported achieving a nutrition or activity goal. Among study completers, ≥60% found the app content at least somewhat helpful. Within-group changes for BeFAB among completers were found for increased moderate-to-vigorous physical activity and decreased fruit/vegetable intake and weight. Findings indicate initial feasibility of recruiting postpartum women to participate in a digital healthy body weight program but limited use, reflecting low acceptability and challenges in engagement and retention. Future research is needed on strategies to engage and retain participants in postpartum interventions.

Background: The majority of women who are pregnant with opioid use disorder (OUD) also smoke tobacco but are rarely offered tobacco cessation counseling. While the effects of exposure to opioids and nicotine in utero are well-understood separately, understanding the impact of the combined exposure to these substances on neonatal outcomes is lacking. Methods: A scoping review was conducted using PubMed and Scopus databases for studies addressing the combined exposure to opioids and nicotine during pregnancy published between 1 January 1980 and 9 July 2019. A total of 29 papers met the eligibility criteria for inclusion, with nine being identified as clinical trials (three from the MOTHER study) and two as secondary data analysis of clinical trial data. Results: Neonatal outcomes for infants who had a combined exposure to opioids and nicotine in utero indicated a reduction in birth weight and birth length. Findings in infants exposed to both nicotine and opioids were mixed with regard to the duration of neonatal abstinence syndrome (NAS), the likelihood of treatment for NAS, doses of medicine used to treat NAS, and NAS scores when compared with infants who had opioid exposure without nicotine. Conclusions: The combined exposure to nicotine and opioids during pregnancy may lead to a reduction in neonatal birth weight and birth length and more severe NAS signs, compared with opioid use alone, but more research is necessary to identify the minimum dosage and length of nicotine exposure to accurately predict these outcomes.

Background: Gestational diabetes mellitus (GDM) is an increasingly common high-risk pregnancy condition requiring intensive daily self-management, placing the burden of care directly on the patient. Understanding personal and cultural differences among patients is critical for delivering optimal support for GDM self-management, particularly in high-risk populations. Although mobile apps for GDM self-management are being used, limited research has been done on the personalized and culturally tailored features of these apps and their impact on patient self-management. Objective: This scoping review aims to explore the extent to which published studies report the integration and effectiveness of personalized and culturally tailored features in GDM mobile apps for patient self-management support. Methods: We examined English-language peer-reviewed articles published between October 2016 and May 2023 from PubMed, CINAHL, PsycINFO, ClinicalTrials.gov, Proquest Research Library, and Google Scholar using search terms related to digital tools, diabetes, pregnancy, and cultural tailoring. We reviewed eligible articles and extracted data using the Arskey and O’Malley methodological framework. Results: Our search yielded a total of 1772 articles after the removal of duplicates and 158 articles for full-text review. A total of 21 articles that researched 15 GDM mobile apps were selected for data extraction. Our results demonstrated the stark contrast between the number of GDM mobile apps with personalized features for the individual user (all 15 mobile apps) and those culturally tailored for a specific population (only 3 of the 15 mobile apps). Our findings showed that GDM mobile apps with personalized and culturally tailored features were perceived to be useful to patients and had the potential to improve patients’ adherence to glycemic control and nutrition plans. Conclusions: There is a strong need for increased research and development to foster the implementation of personalized and culturally tailored features in GDM mobile apps for self-management that cater to patients from diverse backgrounds and ethnicities. Personalized and culturally tailored features have the potential to serve the unique needs of patients more efficiently and effectively than generic features alone; however, the impacts of such features still need to be adequately studied. Recommendations for future research include examining the cultural needs of different ethnicities within the increasingly diverse US population in the context of GDM self-management, conducting participatory-based research with these groups, and designing human-centered mobile health solutions for both patients and providers.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Exclusive breastfeeding (EBF) through 6 months of age in most low- and middle-income countries (LMICs) is surprisingly low. In India, an LMIC, EBF rates fall well below the World Health Organization benchmark of 90%. There has been a relative lack of mobile health (mHealth) applications that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing exclusive breastfeeding practices in LMICs. Objective: A key study objective was to design, develop, and test the usability of BEST4Baby, a mHealth app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India around optimal breastfeeding practices. Methods: To develop and test BEST4Baby, we applied behavioral theories (i.e., social cognitive theory and theory of planned behavior) to a user-centered design (UCD) process with an Agile development methodology. The approach involved stakeholders and PCs to guide BEST4Baby’s design and development including the app’s content and features. PCs were engaged through the use of focus groups with interactive wireframes. Their feedback helped finalize the design prior to development. During the 24-month study period, we conducted a feasibility test of the BEST4Baby app with 23 PCs that supported mothers residing in rural India in a pilot study that incorporated an intervention (n=110) and control (n=112) group. The intervention protocol required PCs to provide education and follow mothers using BEST4Baby from the late prenatal stage of pregnancy through 6 months postpartum. BEST4Baby’s usability from the PCs’ perspective was assessed using a translated System Usability Scale (SUS). Results: The findings of this study align with best practices in UCD (i.e., understand user experience, context with iterative design with stakeholders) to address EBF barriers. It led to the cultural tailoring and contextual alignment of an evidence-based WHO breastfeeding program with iterative design and Agile development of the BEST4Baby app. The approach translated to a highly usable BEST4BABY app for employment by PCs for breastfeeding counseling that has been shown to statistically increase EBF practices. PCs rated BEST4Baby as highly usable, scoring it over the 95th percentile on the SUS scale. Conclusions: Findings suggest that BEST4Baby was highly usable and accepted by PCs in supporting mothers in their EBF practices and led to positive outcomes in the intervention group’s EBF rates. The pilot demonstrated that the use of the specially designed BEST4Baby app was an important support tool for PCs during the nine home visitations.

Background: Breastfeeding rates among US mothers, particularly Black or African American mothers, fall short of recommended guidelines. Despite the benefits of human milk, only 24.9% of all infants receive human milk exclusively at 6 months. Objective: Our team previously explored the key content areas a mobile health intervention should address and the usability of an initial prototype of the Knowledge and Usage of Lactation using Education and Advice from Support Network (KULEA-NET), an evidence-based mobile breastfeeding app guided by preferences of Black or African American parents. This study aimed to identify the preferences and acceptability of additional features, content, and delivery methods for an expanded KULEA-NET app. Key social branding elements were defined to guide app development as a trusted adviser. The study also aimed to validate previous findings regarding approaches to supporting breastfeeding goals and cultural tailoring. Methods: We conducted a qualitative study using in-depth interviews and focus groups with potential KULEA-NET users. A health branding approach provided a theoretical framework. We recruited 24 participants across 12 interviews and 2 focus groups, each with 6 participants. The Data methods aligned with qualitative research principles and concluded once saturation was reached. Given the focus on cultural tailoring, team members who shared social identities with study participants completed data collection and coding. Two additional team members, 1 with expertise in social branding and 1 certified in lactation, participated in the thematic analysis. Results: All participants identified as Black or African American mothers, and most interview participants (7/12, 58%) engaged in exclusive breastfeeding. In total, 4 themes were recognized. First, participants identified desired content, specifying peer support, facilitated access to experts, geolocation to identify resources, and tracking functions. Second, delivery of content differentiated platforms and messaging modality. Third, functionality and features were identified as key factors, highlighting content diversity, ease of use, credibility, and interactivity. Finally, appealing aspects of messaging to shape a social brand highlighted support and affirmation, inclusivity and body positivity, maternal inspiration, maternal identity, social norms, and barriers to alignment with aspirational maternal behaviors as essential qualities. Crosscutting elements of themes included a desire to communicate with other mothers in web-based forums and internet-based or in-person support groups to help balance the ideal medical recommendations for infant feeding with the contextual realities and motivations of mothers. Participants assigned high value to personalization and emphasized a need to achieve both social and factual credibility. Conclusions: This formative research suggested additional elements for an expanded KULEA-NET app that would be beneficial and desired. The health branding approach to establish KULEA-NET as a trusted adviser is appealing and acceptable to users. Next steps include developing full app functionality that reflects these findings and then testing the updated KULEA-NET edition in a randomized controlled trial.