Pandemic Challenges and Opportunities for Gender Equity in Clinical Research

In the arena of clinical research, gender equity accelerates research excellence: we need multiple perspectives and all the brain power we can muster to maximize research productivity and quality. [...]women physician investigators enhance enrollment of women as participants in clinical trials, which is crucial to our ability to generalize from the data and to maintain the health of women. Women are underrepresented among academic grand rounds speakers,14 speakers at medical conferences15, and award recipients from medical specialty societies.16 Time pressure is especially intense on young women faculty. Besides spending more time on domestic chores, they spend more time at work on teaching, service, and mentoring. Female primary care physicians spend more time with patients.22 Elderly hospitalized patients treated by female internists experience lower mortality and readmission rates.23 Patients undergoing coronary artery bypass grafting had shorter hospital length of stay when treated by an all-female physician team as compared with an all-male team.24 Female patients treated by male physicians following acute myocardial infarction have higher mortality than those treated by female physicians.25 Sex discordance between patient and surgeon is associated with increased likelihood of adverse postoperative outcomes-and that observation that is driven by worse outcomes for female patients treated by male physicians.26 Clinical trials play a fundamental role in bringing new medications and interventions to our patients, yet women have often been excluded from participation. Among 60 randomized controlled trials (RCTs) of lipidlowering therapies reported between 1990 and 2018, there was a modest increase in enrollment of women over time, but women remain underrepresented compared with the relative burden of disease.30 In another study of 317 RCTs of heart failure with reduced ejection fraction published in highimpact journals over the past 20 years, only 25% of participants overall were female, and females were under-enrolled in 72% of these trials.

Women in the Workplace: COVID-19 and Work-Life Balance: JMI

The COVID-19 pandemic has cost the lives of an enormous number of individuals around the world, isolated people, and disrupted businesses. These are the direct and devastating consequences of the disease, however there are other peripheral impacts as well. The pandemic is continuing to threaten the work-life balance (WLB) of employees, disrupting their domestic lives, intensifying their general stress levels, and impacting their ability to focus on their careers. This is a significant problem for both working women as well as men, however this study suggests the negative impact is more disruptive to women. Women represent approximately 46% of the human resources for organizations and they are major contributors to advancements in domains such as healthcare, education, government, and commercial development. Organizations, as a defensive measure, need to adapt policies and procedures in an attempt to moderate the disruptive influences the virus is having on their human resources. This paper explores the extant literature and defragments diverse COVID-19 studies to capture an overall picture of the unique impact the pandemic is having on working women. A qualitative study involving semi-structured in-depth interviews with 20 professional women was conducted. Interviews were reviewed holistically with themes across interviews identified. Resulting themes include WLB expectations post-COVID-19, childcare, employers and expectations, and return to work. Thematic findings are discussed and observations relative to organizational implications are provided. Also offered are thoughts and suggestions for the enhancement of WLB, thereby benefiting both women and their organizations.

Converging Crises and the Cost of Exclusion: Unveiling the Invisible Women of Sri Lanka's Economy

In Sri Lanka, womens labor force participation has never exceeded 35% in over three decades. As of 2022, the country was ranked 110 out of 146 countries in the World Economic Forums Gender Gap Index. The gaps in womens participation in the formal economy alongside womens limited political empowerment are two leading causes for the country to be lagging in such global gender equality indicators. At a large cost to the economy, the existence of archaic gender norms that promulgate womens unpaid care work often exclude women from the formal labor force. This paper dissects the socio-economic and socio-political factors that lead to the invisibility of women in Sri Lankas economy, while seeking to understand how such underlying causes have been aggravated within the precarity of the post-pandemic context. It is important, now more than ever, to recognize the invisibility of women in Sri Lankas formal economy, while bringing about a transformative vision with a multi-pronged approach to address existing gaps and challenges. With reference to key principles of feminist economics, including the theoretical foundations of Claudia Goldin, Nancy Folbre, and Diane Elson, among others, the paper will make a case for inclusivity and intersectionality in policy recommendations aimed at encouraging womens entry, active engagement, contribution, and retention in Sri Lankas economy. The paper reaches a conclusion that when women lead, participate, and benefit equally in all aspects of life, societies and economies will thrive, thereby contributing to sustainable development and inclusive economic growth.

Use of all cause mortality to quantify the consequences of covid-19 in Nembro, Lombardy: descriptive study

ObjectiveTo quantify the impact of coronavirus disease 2019 (covid-19) on all cause mortality in Nembro, an Italian city severely affected by the covid-19 pandemic.DesignDescriptive study.SettingNembro, in the Bergamo province of Lombardy, northern Italy.PopulationResidents of Nembro.Main outcome measuresMonthly all cause mortality between January 2012 and April 2020 (data to 11 April), number of confirmed deaths from covid-19 to 11 April 2020, and weekly absolute number of deaths between 1 January and 4 April across recent years by age group and sex.ResultsNembro had 11 505 residents as of 1 January 2020. Monthly all cause mortality between January 2012 and February 2020 fluctuated around 10 per 1000 person years, with a maximum of 21.5 per 1000 person years. In March 2020, monthly all cause mortality reached a peak of 154.4 per 1000 person years. For the first 11 days in April, this rate decreased to 23.0 per 1000 person years. The observed increase in mortality was driven by the number of deaths among older people (≥65 years), especially men. From the outbreak onset until 11 April 2020, only 85 confirmed deaths from covid-19 in Nembro were recorded, corresponding to about half of the 166 deaths from all causes observed in that period.ConclusionsThe study findings show how covid-19 can have a considerable impact on the health of a small community. Furthermore, the results suggest that the full implications of the covid-19 pandemic can only be completely understood if, in addition to confirmed deaths related to covid-19, consideration is also given to all cause mortality in a given region and time frame.

Medical Dental Integration in Wisconsin: Integrating dental hygienists into pediatric well child visits and prenatal care

Disparities exist in access to early oral health care, disproportionately impacting minority ethnic groups and populations with low socioeconomic status. Medical dental integration provides an opportunity to create a new dental access point for early prevention and intervention as well as care coordination. The Wisconsin Medical Dental Integration (WI-MDI) model expanded early access to preventive oral health services by integrating dental hygienists (DHs) into pediatric primary care and prenatal care teams to address oral health inequities with the goal of reducing dental disease. This case study will describe how DHs were incorporated into the medical care teams in Wisconsin and how legislation expanding scope of practice made this possible. Since 2019, five federally qualified health systems, one non-profit clinic, and two large health systems have enrolled in the WI-MDI project. Thirteen DHs have worked across nine clinics in the WI-MDI project and over 15,000 patient visits to a medical provider included oral health services provided by DHs from 2019 to 2023. Dental hygienists working in alternative practice models such as those demonstrated in the innovative WI-MDI approach are positioned to reduce oral health disparities through the provision of early and frequent dental prevention, intervention, and care coordination.

Fitting Percentage of Body Fat to Simple Body Measurements: College Women

Percentage of body fat, age, weight, height, and 14 circumference measurements (e.g., waist) are given for 184 women aged 18–25. Body fat, one measure of health, was accurately determined by an underwater weighing technique which requires special equipment and training of the individuals conducting the process. Modeling body fat percentage using multiple regression provides a convenient method of estimating body fat percentage using measures collected using only a measuring tape and a scale. This dataset can be used to show students the utility of multiple regression and to provide practice in model building.

COVID-19 VACCINE SAFETY DURING PREGNANCY IN WOMEN WITH SYSTEMIC LUPUS ERYTHEMATOSUS

BackgroundVaccinations comprise a part of the antenatal care of pregnant women, including patients with systemic lupus erythematosus (SLE) who are at increased risk of adverse pregnancy outcomes (APOs). While COVID-19 vaccination has been shown to be safe in patients with SLE, data on vaccine-associated adverse events (AEs) during the antenatal and lactation period are scarce or lacking.ObjectivesTo investigate the association between COVID-19 vaccination and AEs in pregnant SLE patients.MethodsA total of 9201 complete responses were extracted on June 21st, 2022 from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) 2 database, a global e-survey involving 157 collaborators from 106 countries. Among respondents, 6787 (73.8%) were women. We identified 70 (1.1%) women who were exposed to at least one COVID-19 vaccine dose during pregnancy, among those 11 with SLE. Delayed onset (>7 days) vaccine-related AEs were extracted and triangulated with disease activity, treatment changes due to flare after vaccination, and COVID-19 infections in vaccinated pregnant women with SLE. Additionally, information on health-related quality of life and physical function was recorded using PROMIS at the time of survey completion.ResultsThe age of patients ranged from 28 to 39 years;5/11 women were of Asian origin. None of these patients reported major vaccine AEs, including four patients with self-reported active SLE prior to the vaccination. None of them reported any change in the status of their autoimmune disease, and no hospitalisation or special treatment was recorded. Six women experienced minor vaccine AEs;two of them had active disease prior to vaccination. Four patients reported COVID-19 infection;two of them while they were pregnant and post-vaccination and two prior to pregnancy and vaccination. All four patients experienced symptoms of their disease, but no overt SLE flare was reported. At the time of survey completion, all patients reported their general health as being good to excellent in all aspects evaluated. Importantly, no APOs were reported.None of the patients reported thrombotic events post-vaccination, which provides some reassurance regarding COVID-19 vaccination in a patient population with a high risk for cardiovascular comorbidity and thrombosis, especially in the presence of antiphospholipid antibodies or in patients diagnosed with the antiphospholipid syndrome, a considerable portion within SLE populations. Moreover, it was reassuring to note an absence of association between experienced vaccine AEs and active disease prior to vaccination. Although minor AEs were common, they did not impair daily functioning, and the symptoms resolved in all patients after a median of 3 (IQR: 2.5–5.0) days.ConclusionOur report adds relevant evidence concerning the sensitive issue of COVID-19 vaccine AEs and flares in SLE patients during the antenatal and lactation period. Despite the small sample size, the findings provide some reassurance and can contribute to informed decisions regarding vaccination in patients with SLE and high-risk pregnancies due to their background autoimmune disease. Based on the present data, the risk/benefit ration of COVID-19 vaccination appears favourable, with vaccines both providing passive immunisation to the fetus and active immunisation to the mother with no signals of exacerbation of the mother's autoimmune disease.Figure 1.Timeline showing COVID-19 vaccination and vaccination-related minor adverse events in relation to gestational and post-partum periods in eleven pregnant/lactating women with systemic lupus erythematosus.[Figure omitted. See PDF]AcknowledgementsThe authors thank all survey respondents, as well as patient associations and all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsNefeli Giannopoulou: None declared, Latika Gupta: None declared, Laura Andreoli: None declared, Daniele Lini: None declared, Elena Nikiphorou: None declared, Rohit Aggarwal Grant/research support from: R.A. has a consultancy relationshi with and/or has received research funding from Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio., Vikas Agarwal: None declared, Ioannis Parodis Grant/research support from: I.P. has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche AG.

Different reversibility of skeletal muscle mass and strength in elderly Japanese women after the first wave of COVID-19

BackgroundRestrictions on outdoor movements due to the coronavirus disease (COVID-19) pandemic have led to a decreased physical activity;this can lead to sarcopenia and frailty in older adults. Our recent study has demonstrated a significant decrease in the trunk muscle mass immediately after the pandemic's first wave (April–May 2020) among Japanese community-dwelling older women. In the present study, we further examined whether muscle mass recovery or deterioration occurs after 1 year of the pandemic's first wave by comparing physical measurements among the following assessment periods: before the first wave, immediately after the first wave, and at 1-year follow-up thereafter.MethodsThis study included 77 women (78.0 ± 5.7 years) who underwent physical measurements for muscle mass, grip strength, one-leg stand-up ability (3 s), and oral motor skills and answered questionnaires on sociality (social network, participation, and support) in the three assessment periods.ResultsThe frequency of going out and the subjective vitality were significantly decreased immediately after the first wave;these recovered at the 1-year follow-up (P < 0.001). When comparing muscular measures, the trunk muscle mass index preferentially decreased immediately after the first wave but recovered significantly at the 1-year follow-up (P < 0.001). Conversely, the appendicular skeletal muscle mass index (ASMI) and grip strength continued to decrease until the 1-year follow-up (P < 0.001 and P = 0.03, respectively). The ability to perform a one-leg stand-up for 3 s and the oral motor skills did not change significantly across the assessment periods. The prevalence of pre-sarcopenia and sarcopenia tended to increase during these periods (P = 0.068). The reduction and subsequent recovery patterns for sociality were similar to those observed for the trunk muscle mass.ConclusionsOur findings demonstrated differences in the reversibility of skeletal muscle mass and strength at 1 year after the first wave of the COVID-19 pandemic: the trunk muscle mass declined acutely and recovered rapidly, whereas the ASMI and grip strength declined continuously. These differences in the skeletal muscle recovery and deterioration might help formulate short-term or long-term strategies for COVID-19-related sarcopenia prevention in community-dwelling older adults.

Clinical Trial Technology: New Kids on the Block are Changing Industry Dynamics

Machine learning depends on training algorithms on large sets of data, Limaye notes, but many pharmaceutical companies securely protect their own clinical trial data in a way that's impenetrable to machine learning algorithms. Limaye adds that federated learning technologies, in which algorithms access data that never leaves its secure location, are emerging solutions to this problem that many drug manufacturers are embracing. According to Ngang, Amgen takes great pains to ensure that everyone, regardless of language or literacy level, understands what they are agreeing to as they begin a clinical trial, and says the same care can be taken with ensuring that all clinical trial participants know how to use a wearable sensor or other digital device. [...]ObvioHealth has developed a platform that continuously collects data gathered from wearables such as blood pressure levels, oxygenation levels, or heart rates of patients in clinical trials for different treatments-with the data fed to the research site in real time (or as soon as possible if the patient loses connectivity).

"Questão social”, divisão sexual do trabalho e saúde mental na pandemia

O presente trabalho analisa as repercussões do acirramento da "questão social” e da divisão sexual do trabalho na saúde mental das mulheres no contexto de pandemia (Covid-19) no município de Aracati-CE. A pesquisa, com abordagem qualitativa-quantitativa, ancorou-se na teoria social crítica de Marx e foi processada em três etapas: a etapa exploratória, a pesquisa bibliográfica e a pesquisa de campo. Esta última, realizada com doze mulheres usuárias do Caps II de Aracati através de entrevista semiestruturada, com suporte do uso de dados indiretos e diretos. Conclui-se que houve a ampliação da produção do sofrimento mental em virtude da agudização da "questão social” e da intensificação da divisão sexual do trabalho no contexto da pandemia.Alternate :This paper analyzes the implications of the intensification of the "social issue” and the sexual division of labor in the mental health of women in the context of a pandemic (COVID-19) in the municipality of Aracati-CE. The research is based on Marx's critical social theory and has a qualitative-quantitative approach comprising three stages: the exploratory stage, bibliographical research and field research. The study was carried out with twelve women through semi-structured interviews and showed that they experience a process of production of mental suffering due to the worsening of the "social issue” and the sexual division of labor in the current pandemic.

Bringing Clinical Trials to the Point of Care

Tryon Medical Partners, based in Charlotte, North Carolina, is a fairly new practice, which broke off from a nearby hospital system approximately three years ago. Overall, the patient does enjoy the experience and when integrated with primary care and their own PCPs, I think clinical trial retention rates are higher because of the attention from their provider." Grayson also sees that the patients are excited to participate when asked, and spread the word to friends and family. Because of the practice population, and history of underrepresentation, Grayson believes that the clinical research information and understanding for them is enlightening.

COVID-19 VACCINE SAFETY DURING PREGNANCY AND BREASTFEEDING IN WOMEN WITH AUTOIMMUNE DISEASES: RESULTS FROM THE COVAD STUDY

Background:COVID-19 vaccine hesitancy among pregnant and breastfeeding women with autoimmune diseases (AID) is often attributed to the fear of adverse events (AE) and disease flares (DF). No data are available regarding COVID-19 vaccine safety in this population.Objectives:We aimed at describing delayed-onset (>7 days) vaccine-related AE (minor and major), DF, and related AID treatment modifications from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.Methods:Among complete responses from 9201 participants as of June 21, 2022, 6787 (73.8%) were women. Six subgroups were identified upon diagnosis of AID vs healthy controls (HC) and their pregnancy/breastfeeding status at the time of any dose of vaccine (Figure 1).Figure 1.Flowchart of the study. AID: autoimmune diseases;HC: healthy controls;rAID: rheumatic AID;nrAID: non-rheumatic AID.[Figure omitted. See PDF]ResultsForty pregnant and 52 breastfeeding AID patients were identified and their vaccination rates (at least one dose) was 100% and 96.2%, respectively (Table 1). Overall AE, minor AE, and major AE were reported significantly more frequently by pregnant than non-pregnant patients (45% vs. 26%, p=0.01;40% vs. 25.9%, p=0.03;17.5% vs. 4.6%, p<0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18% of age- and disease-matched control patients (n=2315). All DF in pregnant/breastfeeding patients were managed with glucocorticoids and a fifth of them required initiation or change in immunosuppressive treatment.Table 1.Characteristics of female subjects according to groups. Percentages in parenthesis. *Pregnancy/breastfeeding status at the time of the survey and/or at the time of at least one dose of COVID-19 vaccine. Chi squared test: ~ p=0.01;° p=0.03;§ p<0.01.Total Women (n=6787)Group A Non-pregnant, non-breastfeeding with AID (n=4862)Group B Pregnant with AID* (n=40)Group C Breastfeeding with AID* (n=52)Group D Non-pregnant, non-breastfeeding HC (n=1749)Group E Pregnant HC* (n=31)Group F Breastfeeding HC* (n=53)Age (median, IQR)47, 35-5850, 38-6134, 31-35.2533, 30-3539, 29-4934, 30-36.533, 30-36Caucasian3225 (47.5)2634 (54.1)12 (30)22 (42.3)538 (30.8)7 (22.6)12 (22.6)No comorbidities3027 (44.6)1815 (37.3)19 (47.5)36 (69.2)1102 (63)17 (54.8)38 (71.7)Number of vaccinated women, n (%)6632 (97.7)4753 (97.8)40 (100)50 (96.2)1710 (97.8)30 (96.8)49 (92.5)≥3 doses4850 (71.5%)3583 (73.7%)26 (65%)33 (63.5%)1155 (66%)23 (74.2%)30 (56.6%)No AE4950 (74.6)3517 (74)~22 (55)~36 (72)1312 (76.7)22 (73.3)36 (73.5)Injection site (arm) pain and soreness630 (9.5)471 (9.9)7 (17.5)7 (14)138 (8.1)2 (6.7)5 (10.2)Minor AE1614 (24.3)1232 (25.9)°16 (40)°12 (24)338 (19.8)7 (23.3)10 (20.4)Major AE285 (4.3)196 (4.6)§7 (17.5)§1 (2)77 (4.5)1 (3.3)3 (6.1)Hospitalization74 (1.1)51 (1.1)2 (5)0 (0)20 (1.2)0 (0)1 (2)ConclusionThis study provides the first insights into the safety of COVID-19 vaccination during the antenatal period in women with AID. While AEs were more commonly reported by pregnant patients with AID, these were no higher than among pregnant healthy controls without AID. These observations are reassuring, likely to strengthen physician-patient communication and overcome hesitancy as the benefits for the mother and fetus by passive immunization are likely to overweigh the potential risks of AE and DF.Reference[1]Fazal ZZ, et al;COVAD Study Group. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022;42:2151-2158.AcknowledgementsThe authors are grateful to all respondents, to all patients support groups, and to all COVAD Study Group collaborators from 106 Countries.Disclosure of InterestsNone Declared.

Was COVID-19 pandemic anxiety reflected on nutritional habits in adults?

PurposeThis study aims to evaluate the reflection of COVID-19 pandemic anxiety experienced in adults on nutritional habits during the COVID-19 pandemic in Turkey.Design/methodology/approachThe study was conducted with 600 adults aged between 19 and 64 years. The general characteristics of the individuals, nutritional habits, use of dietary supplements and COVID-19 pandemic anxiety before and during the pandemic period were questioned via a Web-based questionnaire. COVID-19-related anxiety was assessed using The COVID-19 Phobia Scale (C19P-S) and The State-Trait Anxiety Inventory (STAI). Data analysis was performed using the Statistical Package for Social Sciences, version 24.0.FindingsIn this study, 49.8% of the participants stated that their appetite and food consumption amount increased during the pandemic period. The rate of use of dietary supplements among individuals was found to be 40%. It was observed that the mean body weight and body mass index increased significantly in both genders during the COVID-19 pandemic. It has been determined that anxiety about COVID-19 is higher in individuals and women who start using nutritional support during the pandemic period. The total C19P-S and STAI scores of those who started using a dietary supplement during the pandemic were significantly higher than those who did not use a dietary supplement. Similarly, those whose eating habits changed positively and those who bought more packaged products had higher C19P-S scale mean scores (p < 0.05).Originality/valueDuring the COVID-19 period, it is important to reduce the anxiety levels of individuals, provide psychological support, raise awareness of adequate and balanced nutrition and the correct use of dietary supplements to adapt to the new lifestyle.

Women and Children's Victims of Violence Case Management During COVID-19 Pandemic

Many studies have been conducted to prove the threat of violence against children and women during COVID-19. Unlike other studies, this study focuses more on government services in receiving complaints from victims of violence experienced by women and children during the COVID-19 pandemic. Using case studies as a qualitative method, documentary studies and in-depth interviews have been conducted on 13 informants from various parties in Bandung Regency, West Java, Indonesia. The results showed that the use of digital technology during the pandemic sometimes hampered the follow-up process for complaints of violence by victims due to a lack of equipment and the inability of officers or victims to use it. In addition, there is still a stereotype that the victim is the "guilty party" or "the party who bears the shame" of making the family cover up or refrain from pressing charges. There needs to be collaboration and coordination among the processing and accompanying officers who handle case management of violence against women and children. These cases are multi-dimensional;therefore, they require multiple approaches from many parties.

Effectiveness of Telehealth for Women's Preventive Services

Does telehealth allow for the effective delivery of preventive services for women, and how can it best be used to address these needs?

Heat vs. Health: Home Office under a Changing Climate

Stressors are especially widespread in urban agglomerations. Common themes of built environment interventions that support health and well-being are blue and green infrastructure, indoor and outdoor air quality, thermal comfort, access to natural lighting, and acoustics. Given the current megatrends of increasing summer temperatures and the high popularity of home offices, we aimed at modeling thermal comfort changes of people working at home in three Austrian cities (Vienna, Innsbruck, and Graz) during the next decades until 2090. We present findings based on (I) an inter-disciplinary literature search and (II) indoor and outdoor climate simulations for actual and future climate scenarios. Based on the results, we discuss the potential impacts for work and human health and well-being, and we suggest a framework for the home office in "post-COVID-19 Austria” that integrates social, ecological, and economic aspects. The results of our study indicate that, in future climate scenarios, overheating of the interior can no longer be prevented without active cooling measures and nature-based solutions. Recommendations on the adjustment of behavior under climate change, including greening, adequate ventilation, and cooling techniques, are thus urgently needed for employees who are working from home in order to maintain physical and mental health and wellbeing.

The Impacts of Social and Political Upheaval on Older Adults' Sexuality: A Call to Action

Sexuality educator and author Jane Fleishman discusses the need to focus on sexual pleasure instead of sexual dysfunction for older adults. She exhorts her readers to notice the impact of current political and social upheaval, the pandemic, the recent Dobbs decision, and the concomitant racial violence, climate change, political crises, technological divides, as well as the healthcare system's inconsistencies, which have laid bare disparities, particularly for vulnerable older adults. She encourages scholars, researchers, students, and policy makers to embrace the intersections, develop new tools, and focus on marginalized populations.

Development of an Individualized Responsive Feeding Coaching Intervention

OBJECTIVES/GOALS: Responsive infant feeding (RIF) promotes healthy dietary patterns and infant weight gain. Research is needed to assist caregivers recognize infant hunger/satiety cues and overcome barriers to using RIF. The Learning Early Infant Feeding Cues (LEIFc) intervention was designed to fill this gap by using a validated coaching approach to promote RIF. METHODS/STUDY POPULATION: Guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model, this proof-of-concept study tests the feasibility and fidelity of the LEIFc intervention in mother-infant dyads (N=25). Study visits from the 3rd trimester of pregnancy to 4 months postpartum (PP) are conducted in family homes. Use of RIF via subjective (survey) and objective (video) measures is collected at 1 and 4 months PP. Prenatally written and video material on infant feeding and infant hunger/satiety cues is provided. At 2 and 3 months PP, coaching during a feeding session is provided by a trained interventionist using the SS-OO-PP-RR (super, Setting the Stage, Observation & Opportunities, Problem Solving & Planning, Reflection & Review) approach. Qualitative data on LEIFc are provided by the interventionist and participants. RESULTS/ANTICIPATED RESULTS: To date 25 dyads have been enrolled and 4 have completed all study visits. Preliminary analyses showed that subjective measure of awareness of infant cues increased post intervention (pre, M=4.38 vs post, M=4.63). LEIFc has been well accepted by participants including use of the SS-OO-PP-RR approach. Data suggests refinement to LEIFc is needed to include breastfeeding and mental health support as well as a longer duration of intervention through at least 6 months PP. An experienced interventionist is key to success of the research. All lost to follow-up (n=7) have occurred before the first PP visit suggesting that at study visit closer to birth is needed. Enrollment will continue through December 2022 and data collection through April 2023. DISCUSSION/SIGNIFICANCE: After refinement, the LEIFc intervention will be tested in a pilot RCT. The long-term goal is to implement LEIFc in the curricula of federally funded maternal-child home visiting programs who serve vulnerable populations;those that often have infant feeding practices that do not align with recommendations and are less likely to use RIF.