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A preconception Virtual Patient Advocate (VPA) called "Gabby" supported African-American women to decrease their preconception health risks and may be a scalable resource to increase women's access to preconception care. Aims were to assess the acceptability of a preconception VPA in women living in Australia and document the changes required to adapt Gabby to suit an Australian context. Taking a descriptive qualitative approach, nonpregnant female participants (n = 31), aged 18-45 years, living in metropolitan and regional Victoria, Australia interacted with Gabby. Focus groups (n = 7) that gathered participants' perspectives of their experience with Gabby ran in July-August 2019 before being transcribed verbatim and thematically analyzed. Six interrelated themes and 12 subthemes were identified. Participants found VPAs to be an acceptable provider of health information with potential to increase women's access preconception health advice. Gabby was considered to be trustworthy and was able to develop rapport with participants in a relatively short time. Context-specific, relevant, tailored and trustworthy information and advice were considered more important that Gabby's physical appearance. Participants had strong opinions about potential technological advancements (e.g., reminders and rewards) and addressing navigation issues to increase Gabby's acceptability. Participants envisaged that they would use Gabby for readily available and evidence-based information before seeking advice from a health professional if required. Overall, the concept VPAs to provide preconception advice and Gabby were acceptable to participants. Future development of VPAs, Gabby, and other online technology-based resources should consider women's high expectations of the online health information they choose to interact with.

Importance: Healthy nutrition and appropriate supplementation during preconception have important implications for the health of the mother and newborn. The best way to deliver preconception care to address health risks related to nutrition is unknown., Methods: We conducted a secondary analysis of data from a randomized controlled trial designed to study the impact of conversational agent technology in 13 domains of preconception care among 528 non-pregnant African American and Black women. This analysis is restricted to those 480 women who reported at least one of the ten risks related to nutrition and dietary supplement use., Interventions: An online conversational agent, called "Gabby", assesses health risks and delivers 12 months of tailored dialogue for over 100 preconception health risks, including ten nutrition and supplement risks, using behavioral change techniques like shared decision making and motivational interviewing. The control group received a letter listing their preconception risks and encouraging them to talk to a health care provider., Results: After 6 months, women using Gabby (a) reported progressing forward on the stage of change scale for, on average, 52.9% (SD, 35.1%) of nutrition and supplement risks compared to 42.9% (SD, 35.4) in the control group (IRR 1.22, 95% CI 1.03-1.45, P = 0.019); and (b) reported achieving the action and maintenance stage of change for, on average, 52.8% (SD 37.1) of the nutrition and supplement risks compared to 42.8% (SD, 37.9) in the control group (IRR 1.26, 96% CI 1.08-1.48, P = 0.004). For subjects beginning the study at the contemplation stage of change, intervention subjects reported progressing forward on the stage of change scale for 75.0% (SD, 36.3%) of their health risks compared to 52.1% (SD, 47.1%) in the control group (P = 0.006)., Conclusion: The scalability of Gabby has the potential to improve women's nutritional health as an adjunct to clinical care or at the population health level. Further studies are needed to determine if improving nutrition and supplement risks can impact clinical outcomes including optimization of weight., Clinical Trial Registration: ClinicalTrials.gov, identifier NCT01827215., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Gardiner, Bickmore, Yinusa-Nyahkoon, Reichert, Julce, Sidduri, Martin-Howard, Woodhams, Aryan, Zhang, Fernandez, Loafman, Srinivasan, Cabral and Jack.)

Background: Improving the health of women before pregnancy and throughout a woman's lifespan could mitigate disparities and improve the health and wellbeing of women, infants and children. The preconception period is important for reducing health risks associated with poor maternal, perinatal and neonatal outcomes, and eliminating racial and ethnic disparities in maternal and child health. Low cost health information technology interventions provided in community-based settings have the potential to reach and reduce disparities in health outcomes for socially disadvantaged, underserved and health disparity populations. These interventions are particularly important for Black and African American women who have a disproportionate burden of pregnancy-related complications and infant mortality rates compared to any other racial and ethnic group in the U.S., Methods: This is a hybrid type II implementation-effectiveness cohort study aimed at evaluating appropriateness, acceptability and feasibility implementation outcomes, while also systematically examining the clinical effectiveness of a preconception care (PCC) intervention, the Gabby System, for Black and African American women receiving health services in community-based sites. The intervention will be implemented in six Community Health Centers and six Healthy Start programs across the U.S. Each study site will recruit and enroll 25-50 young Black and African American women who will participate in the intervention for a 6-month period. Appropriateness, acceptability and feasibility of implementing the PCC intervention will be assessed using: 1) Qualitative data derived from individual interviews with Gabby System end-users (clients and patients) and site staff; and, 2) Quantitative data from staff surveys, Gabby System usage and uptake. Aggregate health risk and utilization measures collected directly from the Gabby server will be used to examine the effectiveness of the Gabby System on self-reported behavior change., Discussion: This study will examine implementation outcomes and clinical effectiveness of an evidence-based PCC intervention for Black and African American women receiving services in Healthy Start programs and Community Health Centers. Contextual factors that influence uptake and appropriate implementation strategies will be identified to inform future scalability of the intervention., Trial Registration: ClinicalTrials.gov NCT04514224 . Date of registration: August 14, 2020. Retrospectively Registered.

Background: Preconception care focuses on improving women's health before pregnancy as a means to improve their health and future pregnancy outcomes. How to effectively deliver such care is unknown. The aim of this research was to assess the impact of an embodied conversational agent system on preconception risks among African American and Black women., Methods: We did an open-label, randomised controlled trial of women aged 18-34 years, self-identified as African American or Black, or both, and not pregnant, recruited from 35 states in the USA. Sealed allocation envelopes (in permuted blocks of six and eight, prepared using a random number generator) were opened after enrolment. Intervention participants received an online conversational agent called Gabby that assessed 102 preconception risks and delivered 12 months of tailored dialogue using synthesised speech, non-verbal behaviour, visual aids, and health behaviour change techniques such as motivational interviewing. The control group received a letter listing their preconception risks and encouraging them to talk with a clinician. The primary outcome was the proportion of identified risks at the action or maintenance stage of change at months 6 and 12. The study is registered with ClinicalTrials.gov, NCT01827215., Findings: From March 11, 2014, through July 8, 2018, 528 women recruited from 35 states and 242 cities across the USA received the Gabby intervention (n=262) or were assigned to the control group (n=266). Participants identified a mean of 21 preconception risks per woman (SD 9·9). In the intention-to-treat analysis, at 6 months, intervention women reported reaching the action or maintenance stage of change for 50·0% (SD 28·9) of those preconception risks identified compared with 42·7% (28·3) in the control group (incidence rate ratio 1·16, 95% CI 1·07-1·26; p=0·0004). This result persisted at 12 months., Interpretation: The Gabby system has the potential to improve women's preconception health. Further research is needed to determine if improving preconception risks impacts outcomes such as preterm delivery., Funding: National Institute for Minority Health and Health Disparities., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)