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The explosive pace of development and research in medical extended reality (MXR) is a testament to its promise for health care and medicine. In comparison with this growth, there is a relative sparsity of rigorous clinical trials that establish the efficacy and effectiveness of these interventions. Explicating mechanisms of action across clinical areas and MXR applications is another major area of need. A primary impediment to these goals is a lack of frameworks for trial design, more specifically, the selection of appropriate controls that effectively address unique elements of MXR. This paper delineates a framework for designing controls, sham conditions, and comparators, as well as proposed considerations for MXR trial designs. Special consideration is given to the design of sham conditions. Improved designs would enable more robust findings and the development of generalizable knowledge that could be adopted across MXR interventions.

Gene-environment interaction (GxE) concepts underlie a proper understanding of complex disease risk and risk-reducing behavior. Communicating GxE concepts is a challenge. This study designed an educational intervention that communicated GxE concepts in the context of eating behavior and its impact on weight, and tested its efficacy in changing knowledge, stigma, and behavior motivation. The study also explored whether different framings of GxE education and matching frames with individual eating tendencies would result in stronger intervention impact. The experiment included four GxE education conditions and a control condition unrelated to GxE concepts. In the education conditions, participants watched a video introducing GxE concepts then one of four narrative vignettes depicting how a character’s experience with eating hyperpalatable or bitter tasting food (reward-based eating drive vs. bitter taste perception scenario) is influenced by genetic or environmental variations (genetic vs. environmental framings). The education intervention increased GxE knowledge, genetic causal attributions, and empathetic concern. Mediation analyses suggest that causal attributions, particularly to genetics and willpower, are key factors that drive downstream stigma and eating behavior outcomes and could be targeted in future interventions. Tailoring GxE education frames to individual traits may lead to more meaningful outcomes. For example, genetic (vs. environmental) framed GxE education may reduce stigma toward individuals with certain eating tendencies among individuals without such tendencies. GxE education interventions would be most likely to achieve desired outcomes such as reducing stigma if they target certain causal beliefs and are strategically tailored to individual attributes.

It is possible that tailoring dietary approaches to an individual's genomic profile could provide optimal dietary inputs for biological functioning and support adherence to dietary management protocols. The science required for such nutrigenetic and nutrigenomic profiling is not yet considered ready for broad application by the scientific and medical communities; however, many personalized nutrition products are available in the marketplace, creating the potential for hype and misleading information on social media. Twitter provides a unique big data source that provides real-time information. Therefore, it has the potential to disseminate evidence-based health information, as well as misinformation. We sought to characterize the landscape of precision nutrition content on Twitter, with a specific focus on nutrigenetics and nutrigenomics. We focused on tweet authors, types of content, and presence of misinformation. Twitter Archiver was used to capture tweets from September 1, 2020, to December 1, 2020, using keywords related to nutrition and genetics. A random sample of tweets was coded using quantitative content analysis by 4 trained coders. Codebook-driven, quantified information about tweet authors, content details, information quality, and engagement metrics were compiled and analyzed. The most common categories of tweets were precision nutrition products and nutrigenomic concepts. About a quarter (132/504, 26.2%) of tweet authors presented themselves as science experts, medicine experts, or both. Nutrigenetics concepts most frequently came from authors with science and medicine expertise, and tweets about the influence of genes on weight were more likely to come from authors with neither type of expertise. A total of 14.9% (75/504) of the tweets were noted to contain untrue information; these were most likely to occur in the nutrigenomics concepts topic category. By evaluating social media discourse on precision nutrition on Twitter, we made several observations about the content available in the information environment through which individuals can learn about related concepts and products. Tweet content was consistent with the indicators of medical hype, and the inclusion of potentially misleading and untrue information was common. We identified a contingent of users with scientific and medical expertise who were active in discussing nutrigenomics concepts and products and who may be encouraged to share credible expert advice on precision nutrition and tackle false information as this technology develops.

With the influx of medical virtual reality (VR) technologies, cybersickness has transitioned from a nuisance experienced during leisure activities to a potential safety and efficacy concern for patients and clinicians. To improve health equity, it is important to understand any potential differences in cybersickness propensity among demographic groups, including racial groups. This study aims to explore whether cybersickness propensity differs across racial groups. We collected self-reported cybersickness ratings from 6 racially diverse independent samples within 1 laboratory group (N=931). In these studies, the participants were asked to perform tasks in VR such as traversing environments, pointing at and selecting objects, and interacting with virtual humans. Significant racial differences in cybersickness were found in 50% (3/6) of studies. A mini meta-analysis revealed that, on average, Black participants reported approximately one-third of SD less cybersickness than White participants (Cohen d=-0.31; P<.001), regardless of the nature of the VR experience. There was no overall difference in reported cybersickness between the Asian and White participants (Cohen d=-0.11; P=.51). Racial differences in cybersickness indicate that researchers, practitioners, and regulators should consider patient demographics when evaluating VR health intervention outcomes. These findings lay the groundwork for future studies that may explore racial differences in cybersickness directly.

BackgroundThe correlates and consequences of stigma surrounding alcohol use are complex. Alcohol use disorder (AUD) is typically accompanied by self-stigma, due to numerous factors, such as shame, guilt and negative stereotypes. Few studies have empirically examined the possible association between self-stigma and alcohol-related outcomes.ObjectiveTo investigate the relationship between self-stigma about alcohol dependence and the severity of alcohol consumption and craving.MethodsIn a sample of 64 participants, the majority of whom had a diagnosis of AUD (51), bivariate correlations were first conducted between Self-Stigma and Alcohol Dependence Scale (SSAD-Apply subscale) scores and Alcohol Use Disorders Identification Test (AUDIT) scores, Alcohol Timeline Follow-Back, Obsessive-Compulsive Drinking Scale (OCDS) scores and Penn Alcohol Cravings Scale scores. Based on the results, regression analyses were conducted with SSAD scores as the predictor and AUDIT and OCDS scores as the outcomes.FindingsSSAD scores positively correlated with AUDIT scores, average drinks per drinking day, number of heavy drinking days and OCDS scores (p<0.001, p=0.014, p=0.011 and p<0.001, respectively). SSAD scores were also found to be a significant predictor of AUDIT and OCDS scores (p<0.001 and p<0.001, respectively), even after controlling for demographics.ConclusionsHigher levels of self-stigma were associated with more severe AUD, greater alcohol consumption, and more obsessive thoughts and compulsive behaviours related to alcohol.Clinical implicationsOur results suggest that potential interventions to reduce self-stigma may lead to improved quality of life and treatment outcomes for individuals with AUD.

Virtual clinical trials (VCTs) can satisfy the need for rigorous clinical trials by using distributed technological solutions that eliminate the need for a physical trial site. This report explores potential benefits of using virtual reality (VR) to provide a “virtual site” for VCTs, a shared immersive hub in which VCT participants could experience elements of the trial and interact with the trial team. VR is a communication technology that has been emerging alongside the development of VCTs, although they have never been merged in a substantial way. Many of the gaps within the VCT paradigm are areas in which VR excels. VR environments are standardized and precisely uniform, the technology allows introduction of an almost endless set of stimuli to participants’ visual and auditory systems, and VR systems are adept at capturing precise movement and behavioral data. Although VR has not yet found its way into VCTs, much of the groundwork for such integration has been laid through research and technological development achieved in the past few years. Future implementation of VR within VCTs could move us from site-less trials to those with a virtual site serving as a hub for trial information provision, interaction with trial representatives, administration of evaluations and assessments, and more.

Black communities, compared to White communities, are disproportionately targeted with more unhealthy food advertisements on television and social media. Exposure to unhealthy food and beverage marketing is associated with appetitive sensations, purchase intention, and intake behaviors, which may contribute to poor overall diet quality and worsening nutritional disparities in Black communities. Despite the negative effects, food and beverage companies are expanding their reach and harnessing advanced technology to create immersive experiences using virtual reality (VR). Black young adults may be uniquely vulnerable. We aim to explore the effect of a VR-based fast-food marketing experience (compared with a VR-based nonfood control) on purchase intention, arousal, and hunger in a sample of Black and White young adults. We will recruit 200 Black and White young adults (aged 18-24 years) from the New York City metropolitan area for a 1-time, 2-hour laboratory-based study. After screening and obtaining informed consent, eligible participants will be randomized to 1 of 2 VR conditions: a VR-based fast-food marketing experience (Wendyverse; experimental) or a VR-based nonfood control (Nikeland). In the Wendyverse, users can order from the restaurant operated by Wendy's, play games, meet others who may be visiting the Wendyverse, and access codes that can be used to obtain free food at physical restaurants. The control condition will be the Nikeland app, where participants can play sports, try on apparel, and engage with celebrity athletes. Study personnel will provide a 5-minute training session to participants before beginning the experiment to ensure that they feel comfortable in the VR environment. Participants will otherwise engage with the VR app independently. The primary outcomes will be fast-food purchase intention, assessed via a self-report questionnaire; arousal, assessed via electrodermal activity or skin conductance; and hunger, assessed via salivary reactivity. We will also conduct secondary analyses to examine interactions by race, ethnicity, and food or nutrition insecurity as a proxy for socioeconomic status. Analyses of covariance and multiple linear regressions will be conducted to examine the effects of VR-based fast-food marketing exposure on the relevant outcomes (compared to the control). This study was funded by the National Institute on Minority Health and Health Disparities in September 2024. Recruitment is expected to begin in September 2025. We expect to complete data collection by October 2026 and begin data cleaning and analysis in November 2026. On the basis of previous research and data, we anticipate that young adults randomized to view VR-based food and beverage marketing will self-report higher purchase intention and demonstrate stronger arousal and hunger. The data will be used to support future research and improve the understanding of the effects of digital forms of unhealthy food and beverage marketing on young people. ClinicalTrials.gov NCT06917391; https://clinicaltrials.gov/study/NCT06917391. PRR1-10.2196/69096.

Background Individuals with diabetes experience a wide variety of psychosocial responses to their illness due, in part, to the nature of type 1 and type 2 diabetes. Variation in patient weight may play a central role in these differences, yet its influence on psychosocial variation is largely unknown. The current study investigates the relationship between patients’ perceived weight status and aspects of psychosocial well-being among individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods Individuals who were diagnosed with type 1 or type 2 diabetes were assessed via an online survey from the Diabetes, Identity, Attributions, and Health Study. Participants were categorized into a lower v. higher weight status group based on their self-reported perceived weight. Analyses of covariance were conducted to assess differences in measures of disease onset blame, diabetes stigma, and identity concerns among diabetes type and perceived weight status. Covariates included in our models were gender, age, education, and time since diagnosis. Bonferroni correction was used for post-hoc tests to assess any significant interactions found in our models. Results Findings indicated that weight moderates multiple psychosocial outcomes pertinent to illness experience. Those with T2D and lower weight blamed themselves less for their disease onset, while those with higher weight felt blamed more for their disease onset by others, regardless of diabetes type. Individuals with T1D and higher weight were more frequently and more concerned about being mistaken for having the other disease type (i.e., T2D) compared to those with lower weight. Conclusions Weight is a key influence on the psychosocial outcomes for people with diabetes, but it operates differently in type 1 versus type 2 diabetes. By further examining the unique interaction between disease type and weight status we may be able to improve psychological well-being among affected individuals of all sizes.

BACKGROUNDStudies have demonstrated the role of ghrelin in alcohol-related behaviors and consumption. Blockade of the growth hormone secretagogue receptor (GHSR), which is the ghrelin receptor, has been shown to decrease alcohol drinking and reward-related behaviors across several animal models. We previously conducted a human study testing a GHSR inverse agonist/competitive antagonist, PF-5190457, in individuals who are heavy drinkers and showed its safety when coadministered with alcohol. Here, we conducted a phase IIa experimental medicine study in patients with alcohol use disorder (AUD) to investigate the effects of PF-5190457 on alcohol- and food-related outcomes.METHODSForty-two individuals with AUD (n = 29 completers) participated in a randomized, double-blind, placebo-controlled study where they received PF-5190457 100mg b.i.d. (or placebo) in 2 counterbalanced, within-subject stages. Participants completed an alcohol cue-reactivity (CR) experiment in a bar-like laboratory and a virtual food choice experiment in a cafeteria-like virtual reality (VR) environment. A subset of participants (n = 12) performed a CR task during a brain functional MRI (fMRI) experiment.RESULTSPF-5190457 did not reduce cue-elicited alcohol craving. PF-5190457 reduced virtual calories selected (P = 0.04) in the VR environment. PF-5190457 did not influence neural activation during CR task in the fMRI experiment.CONCLUSIONThis study provides human evidence of the role of GHSR blockade in behaviors related to food selection and highlights the need for future investigations into targeting the ghrelin system in AUD.TRIAL REGISTRATIONClinicalTrials.gov (accession no. NCT02707055).FUNDINGNIDA and NIAAA ZIA-DA000635; National Center for Advancing Translational Sciences UH2/UH3-TR000963.

Background GLP-1 receptor agonists (GLP-1 RAs) have dramatically altered obesity treatment. Media reports suggest that GLP-1 RAs users often report feeling judged for taking a “shortcut” to lose weight, which may be related to negative stereotypes toward people with larger bodies. Media reports also describe negative attitudes about lean people who take GLP-1 RAs to enhance their appearance. The present research used a 2 × 2 experimental design to test the effects of GLP-1 RA use and body size on attitudes and egocentric impressions. Subjects/Methods A sample of 357 U.S. adults ( M age  = 37.8, SD = 13) were randomly assigned to read about a woman, who either was lean or had obesity, and who lost 15% of her body weight either with diet/exercise or a GLP-1 RA. Participants answered questions measuring endorsement of negative weight-related stereotypes and egocentric attitudes toward the woman, as well as beliefs that she took a shortcut to lose weight and beliefs that biogenetic factors caused her baseline weight. Results Negative evaluations and egocentric impressions were stronger toward a woman who lost weight with a GLP-1 RA compared to diet/exercise. Losing weight with a GLP-1 RA led to stronger negative evaluations through higher weight loss shortcut beliefs irrespective of body size. Losing weight with a GLP-1 RA also led to higher egocentric impressions through higher shortcut beliefs, and this effect was stronger for a lean woman. Finally, losing weight with a GLP-1 RA led to more negative evaluations through stronger endorsement of biogenetic causal beliefs for a lean woman only. Conclusions This timely study provides evidence that people with larger and smaller bodies alike are at-risk for being judged for using GLP-1 RAs due to beliefs that these medications are a shortcut. Findings also demonstrate novel reactions related to egotism when weight loss is achieved with pharmacological interventions. Pre-registration and data osf.io/xme4w.