Sensor-Controlled Digital Game for Heart Failure Self-management: Protocol for a Randomized Controlled Trial.

BACKGROUND: Heart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes. OBJECTIVE: This randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors. METHODS: A total of 200 participants with HF, aged ≥45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups. RESULTS: Recruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026. CONCLUSIONS: This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45801.

A Sensor-Controlled Digital Game for Heart Failure Self-Care Based on Behavioral Change Frameworks.

Self-care behaviors are critical to manage the adverse impact of heart failure disease. However, engaging in self-care behaviors such as physical activity or daily weight-monitoring can be difficult due to lack of knowledge or motivation. Digital games can serve as an alternative to traditional patient education to provide information and motivate engagement in critical self-care behaviors. In this paper, we describe a sensor-controlled digital game (SCDG) in which game play is driven by the player's real life self-care behaviors. We also present the design and development of the next iteration of the SCDG based on playtesting results and behavioral theoretical frameworks.

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial.

BACKGROUND: Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF. OBJECTIVE: The aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial. METHODS: English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks. RESULTS: A total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG (14/19, 74%) and CG (13/19, 68%)-participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial. CONCLUSIONS: Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983.

Development of a School-Based Physical Activity Intervention Using an Integrated Approach: Project SMART.

Physical activity (PA) is a health-protective factor with multiple benefits for school-age children, yet only 22% of children and adolescents living in the United States (United States) accrue the recommended amount of moderate to vigorous PA. Given the prevalence of insufficient PA among children, promoting and providing PA opportunities during the school day, especially when integrated into the curriculum and linked to the learning standards, is essential for children. The purpose of this paper is to describe the procedure for the development of a school-based PA program using an integrated approach through the modified intervention mapping protocol (IMP). A total of 22 physical education teachers and 167 children from five different elementary schools were involved in the process. The procedure includes the Self-Determination Theory (SDT) that provides a theoretical framework that plays a vital role in motivating students to have a physically active lifestyle. This study applied SDT and IMP to develop and pilot a PA intervention called Project SMART using an integrative community participatory approach. As a pilot PA intervention, Project SMART is an online educational game where the students navigate a virtual journey across the United States A class's aggregate PA propels the students on their journey, where standards-based modules are unlocked to achieve STEM (science, technology, engineering, and math) and social-emotional learning outcomes while gaining an understanding of the importance of health behaviors and opportunities to habitually engage in healthy decision-making with the support of their peers. Although initially labor intensive for the researchers, the process of tailoring the intervention to the children's contextual and cultural needs has implications for all theoretically grounded and evidence-based PA interventions.

Multi-modal data collection for measuring health, behavior, and living environment of large-scale participant cohorts.

BACKGROUND: As mobile technologies become ever more sensor-rich, portable, and ubiquitous, data captured by smart devices are lending rich insights into users' daily lives with unprecedented comprehensiveness and ecological validity. A number of human-subject studies have been conducted to examine the use of mobile sensing to uncover individual behavioral patterns and health outcomes, yet minimal attention has been placed on measuring living environments together with other human-centered sensing data. Moreover, the participant sample size in most existing studies falls well below a few hundred, leaving questions open about the reliability of findings on the relations between mobile sensing signals and human outcomes. RESULTS: To address these limitations, we developed a home environment sensor kit for continuous indoor air quality tracking and deployed it in conjunction with smartphones, Fitbits, and ecological momentary assessments in a cohort study of up to 1,584 college student participants per data type for 3 weeks. We propose a conceptual framework that systematically organizes human-centric data modalities by their temporal coverage and spatial freedom. Then we report our study procedure, technologies and methods deployed, and descriptive statistics of the collected data that reflect the participants' mood, sleep, behavior, and living environment. CONCLUSIONS: We were able to collect from a large participant cohort satisfactorily complete multi-modal sensing and survey data in terms of both data continuity and participant adherence. Our novel data and conceptual development provide important guidance for data collection and hypothesis generation in future human-centered sensing studies.

Usability Testing of a Sensor-Controlled Digital Game to Engage Older Adults with Heart Failure in Physical Activity and Weight Monitoring.

BACKGROUND: Poor self-management of heart failure (HF) has contributed to poor health outcomes. Sensor-controlled digital games (SCDGs) integrates data from behavior-tracking sensors to trigger progress, rewards, content, and positive feedback in a digital game to motivate real-time behaviors. OBJECTIVES: To assess the usability of an SCDG prototype over a week of game-playing among 10 older adults with HF in their homes. METHODS: During initial play, participants' SCDG experiences were observed in their homes using a checklist based on the seven-item Serious Game User Evaluator (SeGUE) instrument. After a week of game-playing, participants completed a survey guided by the Intrinsic Motivation Inventory, to provide their perceptions of the SCDG's usability. Qualitative analysis via semistructured interview-derived themes on experiences playing the SCDG, perceptions regarding engaging with the SCDG, and any usability issues encountered. RESULTS: Ten HF participants (50% women and 50% White) played the SCDG for an average of 6 out of 7 days. Nine found the SCDG to be interesting, satisfying, and easy to play. The average step count over a week was 4,117 steps (range: 967-9,892). Average adherence with weight monitoring was 5.9 days in a week. Qualitative analysis yielded outcomes regarding attitudes toward SCDG, and barriers and facilitators that influenced participants' engagement with the SCDG. CONCLUSION: To the best of the authors' knowledge, this usability and feasibility study is the first to report an SCDG designed to improve HF self-management behaviors of older adults in their homes. Future research should consider several issues, such as user profiles, prior game-playing experiences, and network conditions most suitable for connected health interventions for older adults living in the community.

Cryptosporidium parvum Infection Depletes Butyrate Producer Bacteria in Goat Kid Microbiome.

Cryptosporidium parvum is an important apicomplexan parasite infecting ruminants and humans. We characterized the impact of C. parvum infection on the goat kid microbiome. C. parvum was orally administered to parasite-naïve goats, and infection was monitored for 26 days in fecal samples using immunofluorescence assay and qPCR tests. Age-matched goats served as uninfected controls. A reduction in body weight gain, diarrhea, and dehydration were observed in infected goats compared to the uninfected controls. Infection decreased the bacterial diversity 5 days post-infection (dpi), but this parameter recovered at 15 dpi. The infection altered the relative abundance of several taxa. A total of 38 taxa displayed significant differences in abundance between control and infected goats at both 5 and 15 dpi. Co-occurrence network analysis revealed that the infection resulted in a differential pattern of taxa interactions and that C. parvum infection increased the relative abundance of specific taxa. The 16S data set was used for metagenome predictions using the software package PICRUSt2. As many as 34 and 40 MetaCyc pathways (from 387 total) were significantly affected by the infection at 5 and 15 dpi, respectively. Notably, C. parvum decreased the abundance of butyrate-producing pathways in bacteria. Low levels of butyrate may increase mucosal inflammation and tissue repair. Our results suggest that the gut inflammation induced by C. parvum infection is associated with the reduction of butyrate-producing bacteria. This insight could be the basis for the development of novel control strategies to improve animal health.

First identification of Cryptosporidium parvum zoonotic subtype IIaA15G2R1 in diarrheal lambs in France.

To date, no information is available about the presence of Cryptosporidium spp. in French sheep, nor their potential role as zoonotic reservoirs. A total of 23 fecal samples were collected from diarrheic lambs (<11 days old) from seven randomly selected farms. Cryptosporidium-oocysts were detected microscopically with Direct Immunofluorescence Assays (DFA) in 23/23 (100%) of fecal samples. PCR-RFLP of the 18S rRNA gene was used to determine species in all samples, and only Cryptosporidium parvum was identified. Isolates were subtyped by sequencing the 60 kDa glycoprotein (gp60) gene. Two zoonotic subtypes within the IIa subtype family were identified, including IIaA15G2R1 (22/23) and IIaA16G3R1 (1/23). This study reports for the first time the identification and genotyping of zoonotic C. parvum subtypes from lambs in France. Sheep could thus play an important role as potential reservoirs for this zoonotic protist.

Molecular characterization of Cryptosporidium isolates from diarrheal dairy calves in France.

Cryptosporidium is an obligate intracellular protist parasite infecting a wide range of vertebrate hosts and causes significant intestinal disease in both animals and humans, as some species are zoonotic. Cattle and especially calves have been identified as one of the most common reservoirs of this protist. However, little is known about the genetics of Cryptosporidium in calves in some regions of France. The aim of this study was to detect and isolate Cryptosporidium spp. in faecal samples from naturally infected pre-weaned calves (≤45 days-old) in France. A total of 35 diarrhoeic pre-weaned calf faecal samples were collected from 26 dairy cattle farms in six departments (French administrative provinces). Cryptosporidium presence was established by microscopically screening samples for oocystes with an immunofluorescent (DFA) staining method. DFA-positive samples were then analysed by PCR-RFLP and 18S rRNA gene sequencing to determine species. Cryptosporidium parvum-positive samples were subtyped via nested PCR analysis of a partial fragment of the 60 kDa glycoprotein (gp60) gene product. Data were then integrated into phylogenetic tree analysis. DFA revealed the presence of Cryptosporidium oocysts in 31 out of 35 (88%) samples. Combined with 18S rRNA gene analysis results, C. parvum was detected in 30 samples. Subtyping analysis in 27/30 samples (90%) of the C. parvum isolates revealed two zoonotic subtype families, IIa (24/27) and IId (3/27). Four subtypes were recognised within the subtype family IIa, including the hypertransmissible IIaA15G2R1 subtype that is the most frequently reported worldwide (21/27), IIaA17G3R1 (1/27), IIaA17G1R1 (1/27), and IIaA19G1R1 (1/27). Two subtypes were recognised within the IId subtype family including IIdA22G1 (2/27) and IIdA27G1 (1/27). These findings illustrate the high occurrence of Cryptosporidium in calves in dairy herds and increase the diversity of molecularly characterised C. parvum isolates with the first description of IIaA17G3R1, IIaA19G1R1, and IId subtypes in France. The presence of zoonotic C. parvum subtype families (IIa, IId) in this study suggests that pre-weaned calves are likely to be a significant reservoir of zoonotic C. parvum, and highlights the importance of animal to human cryptosporidiosis transmission risk. Further molecular studies in calves and small ruminants from other French regions are required to better understand the epidemiology of cryptosporidiosis in France.

Evaluation of different inclusion levels of dry live yeast impacts on various rumen parameters and in situ digestibilities of dry matter and neutral detergent fiber in growing and finishing beef cattle.

This study evaluated the effects of supplementing dry live yeast (LY; Saccharomyces cerevisiae) on in vitro gas production (IVGP) fermentation dynamics, pH, and CH4 concentration at 48 h, and in situ rumen parameters and digestibility of DM (DMD) and NDF (NDFD) of growing cattle during 3 feeding phases: grower (GRW) for 17 d (38% steamed-flaked corn; SFC), transition (TRANS) for 15 d (55.5% SFC: 1.2 Mcal/kg NEg), and finisher (FIN) for 13 d (73% SFC: 1.23 Mcal/kg NEg). Twenty British-crossbred, ruminally cannulated steers (183 kg ± 44 kg) 6 mo of age were blocked by weight into 5 pens containing Calan gate feeders and received a control (CON) diet (17.2% CP, 35.8% NDF, 86.7% DM) without LY on days -12 to 0. After that, animals were randomly assigned to treatments (TRT), 5 animals per TRT: CON or LY at inclusion rates of 5 g/d (LY1), 10 g/d (LY2), or 15 g/d (LY3) top dressed every morning at 0800 for 45 d. The DMD and NDFD were assessed during 7 separate collection days using in situ nylon bags containing 5 g of GRW, TRANS, or FIN diets, incubated at 1200 for 48 h. Protozoa counts (PC) were determined during 5 collection periods. Data were analyzed as a repeated measure within a randomized complete block design, assuming a random effect of the pen. For GRW, TRT altered the total gas production of the nonfiber carbohydrate (NFC; P = 0.045) and the fractional rate of degradation (kd) of the fiber carbohydrate (FC) pool (P = 0.001) in a cubic pattern (P ≤ 0.05): LY2 had the most gas production and fastest kd. TRT also influenced DMD (P = 0.035) and NDFD (P = 0.012) with LY2 providing the greatest digestibility. For TRANS, TRT tended to affect the NFC kd (P = 0.078) and influenced pH (P = 0.04) and DMD (P < 0.001) in which LY2 yielded the fastest kd, highest pH, and greatest DMD. For FIN, there was an effect of TRT on total gas production (P < 0.001) and kd (P = 0.004) of the NFC pool, FC kd (P = 0.012), in vitro CH4 concentration (P < 0.001), PC (P < 0.001), DMD (P = 0.039), and NDFD (P = 0.008). LY1 had the highest PC and provided the greatest DMD and NDFD. LY2 had the fastest kd of both the NFC and FC pools and had the least CH4 concentration. LY3 had the greatest NFC gas production. No specific dose-response pattern was observed, but 10 g/d provided the most beneficial result for all diets. We concluded that supplementation with LY affected IVGP as well as ruminal parameters and digestibilities.

Cryptosporidium parvum-Infected Neonatal Mice Show Gut Microbiota Remodelling Using High-Throughput Sequencing Analysis: Preliminary Results.

BACKGROUND: During the last decade, the scientific community has begun to investigate the composition and role of gut microbiota in normal health and disease. These studies have provided crucial information on the relationship between gut microflora composition and intestinal parasitic infection, and have demonstrated that many enteric pathogen infections are associated with altered gut microflora composition. In this study, we investigated the effects of Cryptosporidium parvum infection (zoonotic protozoan affecting a large range of vertebrates) on both qualitative and quantitative composition of gut microbiota in a CD-1 neonatal mouse model. METHODS: 5-day-old neonate mice were experimentally infected with 105Cryptosporidium parvum Iowa oocysts by oesophageal gavage. The intestinal microbiota of both infected (Cp+) and uninfected (Cp-) mice groups was examined by high-throughput sequencing of the bacterial 16S rDNA gene V3-V4 hypervariable region. RESULTS: The most consistent change in the microbiota composition of Cp+ mice was the increased proportion of bacterial communities belonging to the Phylum Bacteroidetes. In contrast, the microbiota of Cp- mice was associated with increased proportions of several Firmicutes and Actinobacteria phyla members. CONCLUSION: For the first time, our study provides evidence of an association between cryptosporidial infection and gut dysbiosis, thus contributing valuable knowledge to the as-yet little-explored field of Cryptosporidium-microbiota interactions in a neonatal mouse model.

Role of Digital Games in Self-Management of Cardiovascular Diseases: A Scoping Review.

OBJECTIVE: Examine research on the use of digital games to improve self-management (SM) behaviors in patients diagnosed with cardiovascular diagnoses of hypertension, coronary artery disease, heart failure, or myocardial infarction. MATERIALS AND METHODS: For this scoping review, the CINAHL, PubMed, and Web of Science databases were searched for studies published from January 1, 2008 to December 20, 2017 using terms relevant to digital games and cardiovascular diseases (CVDs). RESULTS: Eight articles met the inclusion/exclusion criteria, seven of which presented studies with participants 50 years or older. Five of the eight studies assessed physical activity. Only two studies included a control group. Digital games significantly improved exercise capacity and energy expenditure but did not affect quality of life, self-efficacy, anxiety, or depression. Digital games were found enjoyable by 79%-93% of participants, including those with lower education or age; however, barriers to game use included being tired or bored, lack of interest in digital games, poor perception of fitness through games, sensor limitations, conflicts with daily life routine, and preferences for group exercise. Average adherence ranged from 70% to 100% over 2 weeks to 6 months of study duration, with higher adherence rates in studies that included human contact through supervision or social support. CONCLUSION: Paucity of studies about digital games for CVD SM behaviors precludes the need to undertake a full systematic review. Future studies examining digital games should include larger sample sizes, longer durations, game-design guided by behavioral change theoretical frameworks, and CVD SM behaviors in addition to physical activity behaviors.

Effect of live yeast (Saccharomyces cerevisiae) supplementation on rumen fermentation and metabolic profile of dairy cows in early lactation.

The study evaluated dietary supplementation with live yeast (LY) Saccharomyces cerevisiae (CNCM I-4407, 1010  CFU/g, Actisaf; Phileo Lesaffre Animal Care, France) on rumen fermentation and serum metabolic profile in lactating dairy cows. Fifty Holstein cows received a total mixed ration with (Live Yeast Diet, LYD, n = 25) or without (Control Diet, CD, n = 25) 5 × 1010  CFU/cow/day of LY from 3 to 19 weeks of lactation. Rumen fermentation and serum metabolic profile were measured in eight cows per treatment at 3, 7, 11, 15, 19 weeks post-partum. LYD showed an increased daily milk yield (+4%) over CD (p < 0.05). Mean rumen pH at 4 hr after morning meal was higher in LYD (6.59) than CD (6.32) (p < 0.01). Total volatile fatty acids (VFA) and acetate molar proportion were higher in LYD (114.24 mM; 25.04%) than CD (106.47 mM; 24.73%) (p < 0.05). Propionate and butyrate molar proportions, acetate to propionate ratio, ammonia levels did not differ between LYD and CD. Ruminal lactate was lower in LYD than CD (9.3 vs. 16.4 mM) (p < 0.001), with a 53% decrease in LYD. During peak lactation, LYD had lower serum NEFA (p < 0.05, 0.40 vs. 0.48 mM) and BHBA (p < 0.01, 0.47 vs. 0.58 mM) than CD, lower liver enzyme activities (AST 1.39 vs. 1.54 ukat/L) (p < 0.05). Serum glucose was higher in LYD at peak lactation (3.22 vs. 3.12 mM, and 3.32 vs. 3.16 mM respectively) (p < 0.05). The results confirmed a reducing effect of LY on lactate accumulation in rumen fluid, associated with an increase in rumen pH. Lower serum levels of lipomobilization markers, liver enzyme activities and higher glucose levels may suggest that live yeast slightly mitigated negative energy balance and had a certain liver protective effect.

Efficacy of chitosan, a natural polysaccharide, against Cryptosporidium parvum in vitro and in vivo in neonatal mice.

Cryptosporidiosis is a zoonotic disease caused by species in the genus Cryptosporidium. In young ruminants, Cryptosporidium parvum causes economically significant disease with mild to severe clinical signs and occasional death. The typical clinical course in animals aged 1-3 weeks old is acute diarrhoea. Currently there are no available treatments that are fully effective against cryptosporidiosis in either humans or animals. Therefore there is a critical need for the development of new therapeutic agents. We adapted two in vitro culture systems (HCT-8 and Caco-2 cell lines) for C. parvum infection to investigate the "anticryptosporidial" activity of two chitosans; Chitosan NAG and Chitosan Mix. Chitosan-a naturally-occurring polysaccharide compound-has been found to be active against a variety of diseases, possessing both antimicrobial and anticancer properties. We investigated both chitosan's toxicity and effects on C. parvum in the two in vitro models. To evaluate chitosan's effects on oocyst shedding in vivo, CD-1 neonate mice were orally inoculated with C. parvum oocysts (Iowa strain), treated with chitosan, and compared to infected non-treated animals. Paromomycin, a classical drug used in veterinary medicine, was used as a reference compound. Immunofluorescence techniques were used to analyse the parasites. Our results showed significant reductions in Cryptosporidium oocyst viability (>95%) after oocyst pre-incubation with either paromomycin (P < 0.001), Chitosan Mix or Chitosan NAG (P < 0.001), for 24 h at 37 °C. Additionally, paromomycin, Chitosan Mix, and Chitosan NAG significantly inhibited C. parvum multiplication in HCT-8 and Caco-2 cell lines (P < 0.005). These effects were dose-dependent. In in vivo studies, treatment with both chitosans (Chitosan NAG, Chitosan Mix) or paromomycin sulfate significantly reduced parasite shedding in infected treated newborn mice (-56%, -34.5% and -58%, respectively). In conclusion, these findings provide the first in vitro and in vivo evidence of the anticryptosporidial activities of this natural polysaccharide.