OBJECTIVES/SPECIFIC AIMS: Our goal was to compare the ventriculo-arterial coupling and left ventricular mechanical work of patients with systolic and diastolic heart failure (SHF and DHF). METHODS/STUDY POPULATION: Patients with New York Heart Association Functional Class II-III HF symptoms were included. SHF was defined as left ventricular (LV) ejection fraction<50% and DHF as >50%. Analysis of the fingertip arterial blood pressure tracing captured with a finger plethysmography cuff according to device-specific algorithms provided brachial artery blood pressure and stroke volume. LV end-systolic volume was measured separately via transthoracic echocardiography. Arterial elastance (Ea), a measure of pulsatile and nonpulsatile LV afterload, was calculated as LV end-systolic pressure (ESP)/end-diastolic volume. End-systolic elastance (Ees), a measure of load-independent LV contractility, was calculated as LV ESP/end-systolic volume. Ventriculo-arterial coupling (VAC) ratio was defined as Ea/Ees. Stroke work (SWI) was calculated as stroke volume index×LV end-systolic pressure×0.0136 and potential energy index (PEI) as 1/2×(LV end-systolic volume×LV end-systolic pressure×0.0136). Total work index (TWI) was the sum of SWI+PEI. RESULTS/ANTICIPATED RESULTS: Patients with SHF (n=52) and DHF (n=29) were evaluated. Median (IQR) age was 57 (51–64) years. There were 48 (58%) and 59 (71%) patients were male and African American, respectively. Cardiac index was 2.8 (2.2–3.2) L/minute and 3.0 (2.8–3.3) L/minute in SHF and DHF, respectively (p=0.12). Self-reported activity levels (Duke Activity Status Index, p=0.48) and heart failure symptoms (Minnesota Living with Heart Failure Questionnaire, p=0.55) were not different between SHF and DHF. Ea was significantly lower in DHF compared with SHF patients [1.3 (1.2–1.6) vs. 1.7 (1.4–2.0) mmHg; p<0.001] whereas Ees was higher in DHF vs. SHF [2.8 (2.1–3.1) vs. 0.9 (0.7-1.3) mmHg; p<0.001). VAC was 1.8 (1.3–2.8) in SHF Versus 0.5 (0.4–0.7) in DHF (p<0.001). Compared with SHF, DHF patients had higher SWI [71 (57–83) vs. 48 (39–68) gm×m; p<0.001) and lower PEI [19 (12–26) vs. 44 (36–57) gm×m; p<0.001]. TWI did not differ between SHF and DHF (p=0.14). Work efficiency was higher in DHF than SHF [0.80 (0.74–0.84) vs. 0.53 (0.46–0.64); p<0.001]. DISCUSSION/SIGNIFICANCE OF IMPACT: The results underscore the differences in pathophysiology between SHF and DHF patients with similar symptom burden and exercise capacity. These results highlight the difference in myocardial energy utilization between SHF and DHF.

OBJECTIVES/SPECIFIC AIMS: Nonalcoholic fatty liver disease (NAFLD) affects 1 in 3 Americans and can exist in 2 histological subtypes: simple hepatic steatosis (SHS) and nonalcoholic steatohepatitis (NASH), a clinically aggressive variant. Fatigue is the most common complaint in patients with NAFLD but the etiology of fatigue is unknown. Thus, the goal of this study was to objectively evaluate fatigue via maximal cardiopulmonary exercise testing and identify determinants of exercise intolerance in NAFLD. METHODS/STUDY POPULATION: In total, 14 subjects with histologically confirmed NAFLD were prospectively enrolled. Subjects with cirrhosis or those with known history of heart failure (systolic or diastolic) were excluded. Fatigue was quantified via the Duke Activity Status Index (DASI) questionnaire. A symptom-limited treadmill cardiopulmonary exercise test was performed in all subjects to measure exercise time (ET) and peak oxygen consumption (peak VO2). Doppler-echocardiography was performed to measure systolic and diastolic function. RESULTS/ANTICIPATED RESULTS: The DASI score and ET was significantly reduced in patients with NASH (n=10) when compared to those with SHS [40.2 (IQR=24.2–50.7) vs. 58.2 (IQR=50.7–58.2), p=0.04]; [9.1 (IQR=6.4–12.2) vs. 13.1 (IQR=12.5–13.1) min, p=0.02, respectively] reflecting moderate fatigue and impaired overall exercise capacity. The ET was directly linked to peak VO2 (R=+0.79, p<0.001), VO2 at anaerobic threshold (R=+0.73, p=0.003), and inversely to ventilatory efficiency index (R=−0.785, p=0.001) suggesting impaired cardiorespiratory fitness in those with reduced ET. ET was also linked to several parameters of diastolic dysfunction including left atrial volume index (R=−0.798, p<0.001), and the ratio of early transmitral pulse-wave Doppler flow velocity (E) to early mitral annulus tissue Doppler velocity E’ (E/E’) (R=−0.608, p=0.036), suggesting a role of diastolic dysfunction in patients with NAFLD with exercise intolerance. DISCUSSION/SIGNIFICANCE OF IMPACT: Cardiac abnormalities drive cardiorespiratory fitness and exercise intolerance in patients with NAFLD. These findings are exaggerated in patients with NASH suggesting a link between disease severity in NAFLD, exercise intolerance and diastolic dysfunction.

OBJECTIVES/SPECIFIC AIMS: Oculopharyngeal muscular dystrophy (OPMD) is a rare, late-onset muscular dystrophy that causes severe swallowing impairment (dysphagia). Although promising therapies are in the pipeline, validated dysphagia outcome measures for use in OPMD trials have not been established. Videofluoroscopic swallow studies (VFSS) are considered the clinical gold standard for dysphagia assessment, yet the optimal objective measure of VFSS in OPMD is not known. Our aim was to investigate the utility of the Modified Barium Swallow Impairment Profile (MBSImP) as an objective measure of VFSS in OPMD patients. METHODS/STUDY POPULATION: This was a single-center, prospective, cross-sectional study. In total, 26 individuals with OPMD underwent VFSS and other measures of dysphagia including 50-mL water swallow time (ST). Validity was assessed by examining correlations with an OPMD Global Severity Score (GSS) and with dysphagia duration. RESULTS/ANTICIPATED RESULTS: The MBSImP demonstrated moderate correlations with GSS (Pearson r=0.52, p=0.006) and ST (r=0.39, p=0.049). The relationship between MBSImP and dysphagia duration appeared nonlinear, and levelled off with long dysphagia duration. In contrast, ST did not correlate significantly with GSS (r=0.27, p=0.18), nor with disease duration (r=0.05, p=0.83). DISCUSSION/SIGNIFICANCE OF IMPACT: Objective measurement of VFSS is a promising outcome measure in OPMD. With long disease duration, the MBSImP may not be sufficiently sensitive to detect disease progression. More sensitive measures for scoring dysphagia severity on VFSS should be explored for application to future s of OPMD.

OBJECTIVES/SPECIFIC AIMS: Understand the immunomodulatory effects of anti-thymocyte globulin (ATG) and granulocyte colony stimulating factor (G-CSF) on type 1 diabetes patients using samples and in the preclinical model, the nonobese diabetic mouse. METHODS/STUDY POPULATION: Flow cytometry analysis of phase 1 peripheral blood samples treatment of nonobese diabetic mouse with ATG and GCSF and flow cytometry analysis of immune organs (spleen, lymph nodes, blood, bone marrow). RESULTS/ANTICIPATED RESULTS: Changes in both innate and adaptive immune cell subsets including plasmacytoid dendritic cells, naive, memory, effector CD4+ and CD8+ T-cells, and CD4+ T-regulatory cells and CD8+ T-regulatory cells DISCUSSION/SIGNIFICANCE OF IMPACT: Understanding of immune cell targets for immunotherapy in new-onset type 1 diabetes patients.

OBJECTIVES/SPECIFIC AIMS: Effective HIV therapeutic options for persons with advanced HIV disease whose regimens have failed multiple times are limited. Current clinical practice utilizes regimens comprised of combinations of anti-retroviral (ARV) drugs. Despite the widespread use of ARV medications, optimization of initial treatment composition and subsequent management remains challenging. The goals of this study are (a) to better understand the ARV treatment structuring using prior clinical and patient information including virtual phenotype data and measures of viral load and CD4 cell count. We evaluated the potential impact of ARV strategies on AIDS-defining events and mortality; (b) to assess and understand differences of treatment composition and management when comparing standard ARV strategy (<5 ARVs) with an intensive ARV strategy (at least 5 ARVs). METHODS/STUDY POPULATION: OPTIMA was a tri-national (United States, Canada, and United Kingdom) randomized open label of alternative ARV treatment strategies for patients with advanced HIV disease (CD4≤300 cells/mm3) and evidence of resistance to 3 classes of ARV medications. OPTIMA used a 2×2 factorial design where the 2 factors were an ARV-free period Versus not; and standard Versus intensive ARV regimen. In this study, we focus on participants enrolled in OPTIMA at US participating sites and utilize demographic and clinical data including baseline virtual phenotype, ARV-related data (initial assignments and changes with drugs and dosages), follow-up lab data, AIDS-defining events, and vital status. RESULTS/ANTICIPATED RESULTS: Among 278 US-OPTIMA participants, 146 were randomly assigned to the standard ARV strategy and the rest were assigned to the intensive ARV strategy. Although not the sole factor, baseline virtual phenotype was used in selecting ARV medications within each assigned strategy. Participants in the standard arm exhibited better agreement between virtual phenotype results and the individual drugs selected for their regimen compared with participants in the intensive arm. This agreement had an almost statistically significant impact on survival time. No significant difference was detected in the frequency of ARV changes between standard and intensive ARV groups. DISCUSSION/SIGNIFICANCE OF IMPACT: Even though per design, OPTIMA assigned participants to an ARV strategy using a binary factor (standard vs. intensive ARV) and assessed its effect on HIV-related disease at a coarse level, the trial’s design and rich database allowed for a closer examination of the ARV drug initial selection and subsequent management. Our findings summarize the patterns and discuss the effects of ARV and their management, on AIDS-defining events and survival. Such findings could provide preliminary, yet important insight, in understanding ARV use practice and could inform the conduct of future HIV treatment trials. Since the trial’s randomization was at the ARV strategy level and not the individual ARV drugs, findings cannot be described in terms of causal pathways for specific ARVs.

OBJECTIVES/SPECIFIC AIMS: Cocaine use is a significant health problem in the United States and associated with increased risk of adverse cardiovascular outcomes. Our goal was to evaluate the effects of rapid cocaine infusions on cardiovascular hemodynamics among patients with cocaine abuse disorder. METHODS/STUDY POPULATION: Patients with a history of cocaine abuse but no overt cardiovascular disease received 4 consecutive intravenous infusions of cocaine (0, 10, 20, 40 mg) given in randomized, double-blinded order. The infusion procedure was repeated on 2 consecutive days (4 infusions each day). Following each dose, patients underwent continuous monitoring via fingertip plethysmography for 30 minutes, followed by an additional 30 minutes washout procedure. Patients were surveyed throughout this timeline to record symptoms of cocaine response. Finger tracings were then used to calculate arterial pressure curves and parameters of heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance according to device-specific algorithms. Mean values were calculated over the entire 30 minutes follow-up and peak values were defined as the maximum value sustained over any 60-second interval during the follow-up period. RESULTS/ANTICIPATED RESULTS: Seven patients were enrolled and received cocaine infusions of 2 consecutive days. Cocaine dose was positively associated with mean cardiac output (R=0.489, p<0.001), peak diastolic blood pressure (R=0.435, p=0.001), mean heart rate (R=0.401, p=0.003), peak systolic blood pressure (R=0.399, p=0.003), peak mean arterial pressure (R=0.362, p=0.008), mean systolic blood pressure (R=0.399, p=0.003), +dP/dt (R=0.346, p=0.012), and peak heart rate (R=0.334, p=0.015). Hemodynamic parameters were also predictive of patient-reported symptoms of cocaine response. DISCUSSION/SIGNIFICANCE OF IMPACT: These data confirm the known pharmacologic effect of cocaine to prevent reuptake of neurotransmitters and demonstrate the feasibility of conducting a noninvasive assessment of cardiovascular hemodynamics as a measure of responsiveness to cocaine infusions. This procedure also provides a benchmark to evaluate the potential impact of pharmacologic treatments on cocaine-induced hemodynamic changes and patient perceptions of cocaine response.

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to identify factors influencing parental willingness of adolescent participation in clinical trials. METHODS/STUDY POPULATION: We applied community engaged research principles to conduct a theory-based, cross-sectional study of parental willingness. Parents (N=307) were given a survey from November 2014 to April 2015. Factors influencing parental willingness were identified using binary logistic regression. SPSS version 22.0 was used to perform analyses, and p<0.05 was considered statistically significant. RESULTS/ANTICIPATED RESULTS: The most impactful factor on willingness was Advantages of Adolescent Clinical Research (p = .001), followed by Disadvantages of Clinical Research (p = .006), Knowledge of Adolescent Clinical Trials (p = 0.029), and Perceived Health Status of Adolescent (p = .036). In further exploring the influence of Perceived Advantages and Perceived Disadvantages, “My child will do something to help others.” (p = .026) and “My child is too young to participate in a clinical trial.” was the only significant Perceived Disadvantage (p = .001) were significantly associated with parental willingness. DISCUSSION/SIGNIFICANCE OF IMPACT: Improving parental knowledge and understanding of adolescent clinical trials, the advantages and disadvantages of adolescent participation, and the health status requirements for child participation are important factors to address when influencing parental willingness to allow adolescents to participate in clinical trials. Recruitment strategies that incorporate this information could improve future adolescent participation in clinical trials, ultimately promoting adolescent health and disease prevention.

OBJECTIVES/SPECIFIC AIMS: Nonalcoholic steatohepatitis (NASH) is a common cause of chronic liver disease in the United States characterized by fat accumulation, inflammation, and fibrosis. Higher amounts of fat-free mass (FFM) and lower amounts of fat mass (FM) have been associated with better outcomes in several chronic diseases, recently also in NASH. Body composition is highly influenced by diet. However, the role of diet on body composition in patients with NASH is largely unknown. We hypothesized that consumption of polyunsaturated fatty acids (PUFA), healthy fatty acids mainly found in fish, nuts, and some vegetable oils, is associated with improved body composition, specifically greater FFM and lower FM, in NASH patients. METHODS/STUDY POPULATION: In total, 13 patients with histologically confirmed NASH underwent body composition testing via bioelectrical impedance analysis to estimate FFM% (% of body weight), FM% (% of body weight), and FFM/FM ratio. PUFA and saturated fat consumption was determined by standardized 5-pass 24-hour dietary recall. Correlations were computed using the Spearman rank test. RESULTS/ANTICIPATED RESULTS: Median body mass index (BMI) was 35.7 kg/m2 (32.8–42.7), median age of the sample was 50 years (46.3–57.3), and 73% were female. Median percent of calories from polyunsaturated fat was 6.8% (5.4–9.6). Percent of calories from PUFA was positively and significantly associated with greater FFM% (R=0.56, p=0.049), lower FM% (R=−0.59, p=0.035), and greater FFM/FM ratio (R=0.58, p=0.037). Additionally, a higher PUFA to saturated fatty acids ratio was also significantly correlated with greater FFM% (R=0.58, p=0.039), lower FM% (R=−0.64, p=0.020), and greater FFM/FM ratio (R=0.57, p=0.043). DISCUSSION/SIGNIFICANCE OF IMPACT: In patients with NASH, the consumption of PUFA is associated with higher FFM and lower FM, which suggests a protective role of these nutrients on body composition. A larger study on patients with NASH is warranted to confirm our findings on PUFA consumption and body composition, as well as to determine whether these effects will improve clinical outcomes.

OBJECTIVES/SPECIFIC AIMS: The iobio project enables anyone (eg, diagnosticians, MDs, genetic counselors, citizen scientists) to perform useful analysis of genomic data, without a need to rely on bioinformaticians. iobio uses a novel real-time analysis framework, coupled with powerful visualizations delivered in a standard web browser. The project successfully supports free academic/nonprofit users, but occasions exist where it is more applicable for the project to be delivered commercially. Frameshift Genomics is developing commercial applications and functionality, which will exist alongside and in coordination with the academic project. These products will be marketed to large institutions including genome institutes, hospitals, diagnostic labs etc., but also to individual users who do not have access to large compute resources, or bioinformatic analysts, and everything in between. METHODS/STUDY POPULATION: The commercial iobio project under Frameshift Genomics aims to develop applications and features that cannot be successfully supported by an academic model. For example, when analyses are scaled up to processing of extremely large data sets, a commercial product with access to compute resources makes more sense than an academic tool. Bam.iobio is an application that samples data from sequencing alignment files, taking seconds to generate and visualize statistics representative of the entire file. This app is offered for free academically. When analysis involves thousands of such files, however, the commercial application, multibam.iobio, is more suitable. Other examples, including support for licensed third-party software and permitting extensive computation via cloud platforms, can also only be reasonably be supported via commercial software. Finally, development of commercial applications is driving adoption of more rigorous testing platforms, delivering more robust products. A particular strength of the iobio platform is allowing non-bioinformaticians to understand their data, for example providing quality control functionality providing confidence in data sets and the conclusions drawn from them. Such analyses are critical to all users of genomic data, and the iobio platform is ideally suited to provide an intuitive, integrated framework for performing them. RESULTS/ANTICIPATED RESULTS: The iobio project has been readily adopted by many in the community and shows significant promise for democratizing genomic analysis. Work is ongoing, supported by NIH small business grants, to develop commercial applications that will be marketed to analysts and medical professionals from large genome institutes and universities, to individual project users and citizen scientists. DISCUSSION/SIGNIFICANCE OF IMPACT: There are currently a number of iobio tools available academically, and they have been embraced by many in the genomics community. In fact, a number of popular platforms (eg, Galaxy, the International Cancer Genome Consortium (ICGC) data portal, mygene2 at the University of Washington) have incorporated iobio tools into their own platforms. To date, the gene.iobio variant interrogation tool has been used in a number of diagnostic projects, aiding identification of putative causative variants, and the pre-release version of the commercial multibam.iobio tool has been critical in unearthing data quality problems in project level data.

OBJECTIVES/SPECIFIC AIMS: The goal of this abstract/presentation is to share lessons learned from participation in the NIH SBIR I-Corps Train-The-Trainer Program, discuss our experiences offering programs at our local institutions, and communicate our plans to develop an I-Corps@NCATS program that can be disseminated across the CTSA network. We believe that an I-Corps@NCATS program will enhance the process of scientific translation by taking best practices from NSF I-Corps and adapting the program to meet the needs of biomedical scientists in academic medical centers. By integrating I-Corps@NCATS training, we hypothesize that the clinical and translational investigator base will be better prepared to identify new innovations and to accelerate translation through commercialization. METHODS/STUDY POPULATION: The diverse, interdisciplinary team of investigators involved in this project span 9 CTSA Hubs, including UAB, Rockefeller, UC Denver, HMC-Penn State, UMass, UC Davis, Emory/Georgia Tech, Miami and Michigan. This team was funded by NCATS in 2015–2016 to participate in the CTSA I-Corps Train-The-Trainer Program in conjunction with the NIH-SBIR/STTR I-Corps national program. The goals were to observe the curriculum, interact with and learn from the NSF National Teaching Team and begin implementation of similar programs at our home institutions. Our I-Corps@NCATS team has been holding monthly, and more recently weekly, conference calls to discuss our experiences implementing local programs and to develop a strategy for expanding CTSA offerings that include innovation and entrepreneurship. Our experience revealed several challenges with the existing NSF/NIH I-Corps program offerings: (1) there is no standard curriculum tailored to academic clinical and translational research and biomedical innovations in the life sciences, and (2) the training process to certify instructors in the I-Corps methodology is a much more rigorous and structured process than just observing an I-Corps program (eg, requires mentored training with a national NSF I-Corps trainer). Our team is proposing to address these gaps by taking best practices from NSF I-Corps and adapting the program to create the I-Corps@NCATS Program, tailored to meet the needs of researchers and clinicians in academic medical centers. RESULTS/ANTICIPATED RESULTS: There are 3 primary anticipated results of our project. First, develop a uniform curriculum for the I-Corps@NCATS Program using the National Teaching Team of experts from the NIH’s SBIR I-Corps program. Second, build the I-Corps@NCATS network capacity through a regional Train-The-Trainer Program. Third, develop a set of common metrics to evaluate the effectiveness and impact of the I-Corps@NCATS Program across the community of CTSA Hubs and their respective collaborative networks. DISCUSSION/SIGNIFICANCE OF IMPACT: Over the past 10 years, CTSA Hubs have accelerated science by creating/supporting programs that provide research infrastructure, informatics, pilot funding, education/training, and research navigator services to investigators. These investments help to ensure that we are “doing science right” using the best practices in clinical research. Even so, it is equally important to make investments to ensure that we are “doing the right science.” Are our investigators tackling research problems that our stakeholders, patients, and communities want and need, to make sure that our investments in science have real-world impact? In order to accelerate discoveries toward better health, scientists need to have a better way to understand the needs, wants and desires of the people for whom their research will serve, and how to overcome key obstacles along the path of innovation and commercialization. To fill this gap, we propose that the CTSA Hubs should include in their portfolio of activities a hands-on, lean startup program tailored after the highly successful NSF Innovation Corps (I-Corps) program. We hypothesize that by adapting the NSF I-Corps program to create an I-Corps@NCATS program tailored to medical research, we will better prepare our scientists and engineers to extend their focus beyond the laboratory and broaden the impact of their research. Investigators trained through I-Corps@NCATS are expected to be able to produce more innovative ideas, take a more informed perspective about how to evaluate the clinical and commercial impact of an idea, and quickly prototype and test new solutions in clinical settings.

OBJECTIVES/SPECIFIC AIMS: To develop a regulatory science case study as an educational resource to inform the regulatory science considerations in medical product development for a range of scientific priority areas and emerging technologies. METHODS/STUDY POPULATION: Precision medicine represents one of the major regulatory science priority areas and the use of biomarkers holds promise for predicting the response to individual treatment strategies. Although progress has been made toward developing biomarkers, the development and validation of clinically useful biomarkers has presented significant regulatory science challenges, including the utilization of biomarkers in predicting responses to different cancer therapies. This case study reviews the technical, regulatory, and policy issues related to the development and use of lung cancer drugs Opdivo® and Keytruda® and an understanding of the codevelopment and utilization of their associated biomarkers. RESULTS/ANTICIPATED RESULTS: A detailed instructor guide with extensive resources such as diagrams and timelines will accompany the case study and will be used to highlight the development and approval process of 2 competing drugs and their associated biomarkers. The resources will provide a better understanding of their progression through the FDA regulatory process and opportunities and challenges for their use. DISCUSSION/SIGNIFICANCE OF IMPACT: Building on the case study framework we have developed, the detailed timelines and a collection of available resources, an extensive and modular case study will be finalized and made available to academic institutions, industry, regulatory agencies, and the public. The full case study and links to a series of resources will be disseminated as a standalone resource for integration into courses or programs interested in learning about specific regulatory science needs and opportunities to enhance medical product development and approval.

OBJECTIVES/SPECIFIC AIMS: The majority of obese adults do not become obese until adulthood. Although adults spend the equivalent of a 40-hour work week in front of the television (TV), there are mixed data on whether the sedentary behavior of TV viewing is linked with weight gain during adulthood. The purpose of this study was to examine the associations among sedentary behavior, measured as TV viewing and TV in the bedroom, with eating behavior, eating attitudes and cravings, fat gain, and blood pressure in healthy young adults over a 2-year period. METHODS/STUDY POPULATION: The sample included 73 healthy, nonobese adults (56% women, 80% white) who were 26.8±4.5 years of age with a body mass index of 22.9±2.4 kg/m2. Participants completed clinic visits at baseline and 2-years later (Year 2) which assessed weight, height, blood pressure, waist circumference, and total body fat measured by dual energy X-ray absorptiometry. A food frequency questionnaire was used to estimate dietary intake, and the eating inventory was used to assess dietary restraint, disinhibition, and hunger. At baseline, participants self-reported TV habits including number of hours/week of watching TV (including cable, VCR, DVD) and presence of a TV in the bedroom. For the analysis, participants were stratified by quartiles of TV viewing time. T tests were used to examine the association between TV viewing and bedroom TV. Linear regression models were used to examine the association between TV viewing and each anthropometric and body composition measure and change over the 2-year period, as well as with the dietary constructs. Models controlled for age, sex, and baseline body fat. Separate models were used to investigate the associations between bedroom TV and the same dependent variables. RESULTS/ANTICIPATED RESULTS: Participants reported an average of 13.3±10.8 hours/week of TV viewing, with 33.3% reporting a TV in the bedroom. There were no differences in age, sex, or race among the quartiles of TV viewing or between those who did and did not have a bedroom TV. Adults with a bedroom TV did not differ in hours/week of TV viewing compared with those without a bedroom TV. Amount of TV viewing was associated with higher systolic blood pressure at baseline (p=0.05) but with no other anthropometric or body composition indices nor with change in body composition over the 2-year period. Adults with a bedroom TV reported higher craving for sweets at baseline (p=0.03). Amount of TV viewing was related to lower consumption of vegetables (p=0.04) and fruit or fruit juice (p=0.03) at Year 2, but there was no association with total calorie consumption. TV viewing and bedroom TV were not related to dietary restraint, disinhibition, or hunger at either time point. DISCUSSION/SIGNIFICANCE OF IMPACT: Adults who watched more TV consumed fewer fruits and vegetables, and those with a TV in the bedroom reported higher craving for sweets. Though there were no observed relationships between TV habits and body composition change, the associations with cravings and food consumption warrant further exploration. Querying young adults’ TV and media use habits in clinical settings may alert physicians to those at risk of developing poor dietary habits.

OBJECTIVES/SPECIFIC AIMS: The American Academy of Pediatrics (AAP) recommends that preschool-aged children spend no more than 2 hours/day using digital screens such as TVs. However, there is a proliferation of digital screens in children’s daily lives both at school and at home. The purpose of this study was to examine factors that contribute to children’s screen-time, including their demographic characteristics and whether or not they have screen-time at school. METHODS/STUDY POPULATION: In total, 59 children (3.3±0.4 years of age; 47% female) enrolled in 3 child care centers participated. Center directors reported school screen-time; 1 center was classified as not providing screen-time and 2 centers were classified as providing screen-time. Parents reported child’s age, sex, and maternal education as a proxy for socio-economic status. Parents reported child’s out-of-school screen-time by responding to the question “During the past 30 days, on average how many hours per day did your child sit and watch TV or videos outside of school?” Additional questions queried how many hours per day did the child “use a computer or play computer games,” “play video games,” “use a smartphone,” and “use an iPad or tablet.” Children’s height and weight were collected using standard clinic procedures and body mass index (BMI) was calculated. T tests were used to examine differences in screen-time by age, sex, and school screen-time. General linear models were used to examine the influence of school screen-time (1=no screen-time, 0=between 1 and 60 min/day of screen-time), age, BMI, and maternal education on out-of-school screen-time and time spent with each device. Logistic regression analysis was used to examine likelihood of meeting screen-time recommendations based on the same characteristics. RESULTS/ANTICIPATED RESULTS: Parent-reported total screen-time was 6.3±3.6 hours/day (h/d); specifically, 2.5±1.1 h/d watching TV, 1.5±2.2 h/d using a smartphone, 1.1±0.9 h/d using a tablet, 0.8±1.0 h/d on a computer, and 0.5±0.7 h/d playing video games. Based on total screen-time, 15% of children met AAP recommendations; based on TV viewing only, 52% met AAP recommendations. The 4-year-old children viewed more screen-time overall compared to the 3-year-old children including on TV, computer, and tablet (p<0.05), but there were no sex differences. In fully adjusted linear models, out-of-school screen-time was lower among those who had no screen-time at school (p=0.02) and higher among older children (p<0.01). Computer use was higher among older children (p=0.02). Older children and those with lower maternal education were less likely to meet clinical recommendations based on TV viewing (p<0.05). There were no observed associations with likelihood of meeting clinical recommendations based on total screen-time. BMI was not a significant predictor of screen-time. DISCUSSION/SIGNIFICANCE OF IMPACT: The majority of children exceeded AAP screen-time limits, with screen-time sharply higher among older children, and the associations did not vary by weight status. Children who attended schools that allowed screen-time had higher amounts of out-of-school screen-time. Pediatricians and healthcare providers should query parents on children’s screen-time practices at home and at school and offer strategies to help families meet the clinical recommendations.

OBJECTIVES/SPECIFIC AIMS: This project has 2 overarching objectives: (1) to investigate the acceptability of the Michigan Surgical and Health Optimization Program (MSHOP) among referred patients, and to describe individual motivations behind enrollment Versus nonenrollment; and (2) to identify patient and program related factors associated with adherence and LOS and readmission rates. METHODS/STUDY POPULATION: Hypothesis—(1) MSHOP participants will report overall satisfaction with the program. Individuals that are satisfied with the program will be likely to perceive the program as effective. Subjects that declined MSHOP will be more likely to perceive their outcomes as immutable. (2) MSHOP patients will have shorter hospital stays and fewer readmission compared with patients who declined MSHOP. Methods—this study will use both qualitative and quantitative methods to investigate patient experiences and program efficacy. First, a convenience sample of patients who were referred to the MSHOP within the previous 12 months will participate in structured interviews to assess program acceptability, patient satisfaction with individual components of MSHOP, and perception of program efficacy. Interviews will also include patients who declined to enroll in MSHOP. Interviews for these subjects will include questions that assess why patients chose to decline enrollment. Second, there will be a retrospective cohort study comparing hospital outcomes among patients who enrolled in MSHOP Versus those who chose not to enroll. Analysis—interviews will be recorded and transcribed for thematic analysis to identify patterns associated with satisfaction or dissatisfaction with the MSHOP. Multivariate regression will be used to determine effect of MSHOP participation on postsurgical length-of-stay and 30-day readmission rate. Demographics and procedure type will be included as covariates. RESULTS/ANTICIPATED RESULTS: In total, 28 interviews have been transcribed, and are in the initial stages of thematic analysis. Interviews have thus far suggested that patients have been satisfied with MSHOP and would recommend the intervention to other patients. Retrospective data regarding hospital length of stay for MSHOP patients from September 2014 to December 2016 has been acquired and is being processed. The characteristics of patients that tend to participate more actively in MSHOP will be explored. We anticipate that active participation in the MSHOP will be associated with shorter hospital stays and fewer readmissions. DISCUSSION/SIGNIFICANCE OF IMPACT: This study will be one of the first to characterize patient perception of MSHOP, in particular its use of tracking step counts and breathing exercises to promote a form of prehabilitation that is easier to integrate into daily life. This project will investigate MSHOP’s effect on patient outcomes, as well as explore factors that may associate with better patient adherence and outcomes. This would help further optimize the MSHOP as an intervention.

OBJECTIVES/SPECIFIC AIMS: Motivation deficits are one of the strongest determinants of poor functional outcomes in people with schizophrenia. Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior. The objective of this study is to describe the intervention protocol and initial effectiveness of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS). METHODS/STUDY POPULATION: This pilot study will examine the effects of MEMS compared with a control group using a randomized design. Up to 40 outpatients with a schizophrenia-spectrum disorder will be recruited. All participants will set individualized recovery goals to complete over an 8-week period; those randomized to receive MEMS will also receive 3 sets of personalized, interactive text messages each weekday to reinforce and cue goal completion. Before and after the 8-week period, participants in both groups will complete validated measures of motivation, quality of life, and functioning. Both groups will also report their goal attainment after 8 weeks. RESULTS/ANTICIPATED RESULTS: It is anticipated that those in the MEMS group will demonstrate greater goal attainment and improvements in motivation, quality of life, and functioning compared with the control group. DISCUSSION/SIGNIFICANCE OF IMPACT: This project will test the initial effectiveness of a novel intervention for improving one of the most debilitating aspects of schizophrenia.

OBJECTIVES/SPECIFIC AIMS: To analyze how consumer physical activity monitors are currently used in biomedical research. METHODS/STUDY POPULATION: Searches were conducted in Ovid Medline, PubMed Medline, clinicaltrials.gov, and NIH RePORTER using search terms including Fitbit, Jawbone, Apple watch, Garmin, Polar, Microsoft band, Misfit, Nike, Withings, and Xiaomi. Results were quantitated by category: condition/topic, intervention, enrollment status, study type and design, age, grant mechanism, and primary outcome. RESULTS/ANTICIPATED RESULTS: Fitbit is used >80%. There are 127 clinical studies using Fitbit devices listed in clinicaltrials.gov. In total, 48 have been completed while 79 are ongoing. Some studies have already published their findings; 40 papers cited in Ovid MEDLINE report use of a Fitbit device. NIH is now funding research that uses consumer physical activity monitors, and the NIH RePORTER shows the number of grants using Fitbit is rapidly increasing. DISCUSSION/SIGNIFICANCE OF IMPACT: The current state and potential growth of this technology is transforming biomedical research and is enabling us to ask new and more granular questions about activity and sleep in health and disease.

OBJECTIVES/SPECIFIC AIMS: The goal of the eResearch platform is to make consenting for clinical trials more convenient, accessible, and faster while retaining an ethical and informed consenting process. eResearch e-consent also allows for enhanced standardization and efficiency for research collaborations across academic research institutions, which, ultimately, helps drive discovery of better health care for our patients and communities. METHODS/STUDY POPULATION: The UMN’s CTSI and AHC Information Systems developed software, called eResearch Suite, for electronic consenting. The eResearch Suite includes viewing a consent, a “Check Your Understanding” quiz to assess comprehension of critical study details, and a signature block that captures the participant signature electronically and with an automatic date and time stamp. The eResearch Suite also has the capability to randomize participants, track participants via a master list, collect participant data, collect internal study data, and generate emails to participants. The eResearch Suite platform is written in Ruby on Rails. RESULTS/ANTICIPATED RESULTS: We have pilot tested the eResearch platform with one study thus far. Preliminary results of the study show that all participants consented via eResearch, with 64% of participants consenting remotely via eResearch before their first study visit. Participants e-consented using various devices including desktop computers, tablets, and smart phones. Participants also filled out surveys and questionnaires before their study visits, which saved the study team time and money. DISCUSSION/SIGNIFICANCE OF IMPACT: eResearch electronic consenting (e-consenting) changes the way potential participants consent for studies. e-Consenting is important because it allows individuals, or their Legally Authorized Representatives, to consent remotely. This may be faster, more convenient for people, reduce coercion, increase comprehension, and allow for consenting information or process to be shared with an individual’s family/friends. In acute and emergent settings we anticipate eResearch e-consenting will result in significant reduction of consent time by replacing faxed and paper consent with e-consent available via email and mobile devices. This allows legally authorized representatives to sign consent remotely, reduces the time physicians spend faxing consents, and allow them to avert more focus back on their patients. Time savings, whether for consent or study visits, may also result in a cost savings for studies.

OBJECTIVES/SPECIFIC AIMS: This study sought to develop a mHealth application which was capable of predicting the spread of infectious diseases during the height of the Ebola outbreak in Lagos, Nigeria. Following the success of this primary task, the research then sought to understand behavioral health issues which are indicative of chronic diseases, such as sedentary behaviors and where they occur at a geospatial level in real-time. The results of this study are now being used to develop a larger scale 500 person study in Rochester, NY, USA. METHODS/STUDY POPULATION: During a 3-month period individuals were asked to install a mobile health application known as Node onto the their android device. Consent was done remotely, individuals were recruited through the Lagos University Teaching Hospital, Nigeria Institute of Medical Research, and the University of Lagos. Participants were paid 50 USD/month for each month of study completion, while continuous location data was collected in addition to survey information about participants. RESULTS/ANTICIPATED RESULTS: During the study period 70 individuals enrolled, using this data we were able to create network based models which indicated that diseases were more likely to spread at the beginning of the week, and also indicated who would be most susceptible to being patient zero. In phase 2 we have started to look at behavioral patterns to determine the risk of chronic disease among our study population, by examining their human mobility patterns, since we can determine average sleep patterns, activity patterns using machine learning classifiers, and time spent in traffic—all of which we can visualize in a real-time geospatial manner with higher objectivity than traditional mechanisms for data collection. DISCUSSION/SIGNIFICANCE OF IMPACT: In developing countries, using Nigeria as our example most chronic disease and household studies only enroll a few thousand participants for a country numbering 150 million plus. Using our rapidly available application we were able within 1 week to enroll 70 participants on 1 year of funding, this creates a framework for larger scale public health studies which can be done in developing countries and also demonstrates the value in mHealth which can both answer questions of infectious disease and chronic diseases at the same time. Our results indicate that at an infectious disease level in city environments diseases may be prevented by targeting events early in the week. While at a chronic disease level the lack of reliable power results in less sedentary behavior as individuals seek locations to charge phones, while those with more stable western-like lifestyles have started to exhibit the conditions which cause such outcomes as obesity, which has begun to rise in developing countries. Ultimately, these results serve as a staging point to launch a more wide scale study both in the United States and Nigeria within the year, now that feasibility has been established.

OBJECTIVES/SPECIFIC AIMS: Our objectives with this project are to engage communities through technology creating a communication channel with affected communities and stakeholders about mosquito-borne illness, vector control and environmental health risk. Furthermore, engaging communities to electronically map ecological risks that impact mosquito-borne illness with the goal of creating a mobile application that will work as an ecological surveillance against mosquito proliferation and potential mosquito population reduction, and finally pilot test and evaluate potential benefits in communities where the application was used. METHODS/STUDY POPULATION: We propose a methodology to perform formative community work that will underscore a distributed, democratized ecological surveillance through an integration of multidimensional health behavior theories that address the challenges of ZIKV in Culebra, a marginalized island community off the coast of the main island of Puerto Rico. Using participatory design, we will develop, test, and evaluate users’ experiences towards mobile applications using qualitative (interviews) and quantitative (survey) methodologies. A mobile application with the capacity of mapping, use of social-media, crowdsourcing, and photo-voice in a dynamic and simple way will allow community members to alert “hot-zone” locations to the stakeholders interested in creating ecological action in their community. This multidimensional concept integrates explanatory and prospective approaches and will generate systematic short-term solutions for mosquito control and long-term solutions providing the necessary tools for community empowerment. RESULTS/ANTICIPATED RESULTS: Our proposed design will facilitate better understanding of the interactions between community members and socio-environmental determinants of mosquito-borne diseases. Furthermore, our proposed project will not only facilitate communication among members of a community, but also it will provide a platform for engagement and empowerment, establishing a change in the preventive paradigm of how communities face the negative impacts of micro-ecologies that surround them. DISCUSSION/SIGNIFICANCE OF IMPACT: Our proposed community collaboratory mHealth tool mZAP! (Zonas, Accion y Proteccion) will address the lack of community participation efforts against mosquito-borne diseases contributed simultaneously by the disengagement and disempowerment of community members. mZAP! will serve as an innovative tool to engage marginalized and communities made vulnerable in Puerto Rico. This approach should be successful as Puerto Rico is one of the most digitally connected countries in Latin America, with high mobile phone usage rates and social media use. Using mZAP!, communities will report and map breeding sites, use social media and crowd sensing, targeting against powerful tools against mosquito ecologies in their own environments. This application could result in an effective way to change the paradigms for public health approaches to use Information Communications Technologies (ICTs) to empower communities.

OBJECTIVES/SPECIFIC AIMS: To assess the usability and adoption of RxUniverse, a novel platform that enables health care providers to directly disseminate proven, evidence-based mobile health apps to patients. METHODS/STUDY POPULATION: Among 5 pilot clinical sites, 40 physicians and front-line providers consisting of medical assistants and receptionists were trained on the RxUniverse platform. They were instructed on the platform’s purpose, were shown a demonstration of the functionality, and were observed in a trial process of prescribing an app. Specific implementation plans were designed with the help of the clinic staff in order to best fit in with their present workflows. The well-validated System Usability Score (SUS) was used to assess the usability of the platform. Prescriptions of 100 relevant app prescriptions within a 8-week pilot period was set as the adoption goal. RESULTS/ANTICIPATED RESULTS: Within the pilot period, greater than 2000 apps were prescribed across all users. Of the 40 providers trained on the RxUniverse platform, 26 prescribed >5 apps during the trial period. Of these 26 individuals, 18 prescribed >20 apps, 14 prescribed >50 apps, and 5 prescribed >80 apps; 58% of users reported frequent use (weekly or daily) of the platform. In total, 19 responses were received for the SUS survey. The RxUniverse platform received a usability score of 82%. DISCUSSION/SIGNIFICANCE OF IMPACT: As the pace of innovation continues to accelerate, health care providers will need to quickly integrate new digital-based tools into their workflows, and patients will need to be able to easily and readily access these tools. RxUniverse provides the necessary mechanisms, user-friendly interface, and EHR integration functionality to accomplish this. The total number of apps prescribed surpassed 2000, which far exceeded the initial target of 100 apps. The platform also scored an 82% on the SUS, which is considered an “A” by industry standards. By comparison, other health apps considered to have to be in the highest-rating groups have reported scores of 77.5% and an overall average of 68% among all systems. These outcomes demonstrate the high adoption and usability of the RxUniverse platform, an important platform that can be used to prescribe the latest technologies directly to patients.