HHS SBIR RFA-HL-12-024

BACKGROUND AND RATIONALE:

The public health infrastructure is being overwhelmed by problems related to over-eating and under-exercising, and it has become clear that many, perhaps most, people have difficulty assimilating and implementing information on optimal diet and physical activity. Furthermore, the emotional, cognitive, and logistical complexities of diabetes management have resulted in a situation where a large fraction of patients are in sub-optimal glycemic control, leading to poor clinical outcomes and high expenses. Even if individuals are willing to adhere to professional and public health guidance, it is hard to navigate the emotional demands, environmental choices and opportunity cost issues that present themselves at the point of decision. This is the cause of failure for many approaches seeking to promote positive behavioral changes, which is of particular concern for individuals with obesity and diabetes. 

Online communities and virtual worlds with avatars (animated characters representing oneself or others) are increasingly a component of the everyday social world for many people.  Virtual Reality (VR) technologies might prove useful in bridging the gap between information (healthy population guidance or therapeutic lifestyle change guidance for obesity and diabetes) and sustainable behavior change. VR technology allows users to interact with (rather than simply observe) computer-simulated environments, typically with adapted flat-screen monitor displays or stereoscopic goggles, but also sometimes with tactile (“haptic”) or other sensory feedbacks including taste and smell.

VR applications are currently in development and use for a number of health- and medicine-related issues, notably rehabilitation medicine (stroke, Parkinson’s disease, pain control in burn victims), behavioral medicine (phobias, post-traumatic stress disorder, drug addiction, autism), and surgery (technical training, robotics, remote site treatment). However, except for small studies in clinical eating disorders (anorexia, binge eating), there has been almost no development of the VR field in relation to common issues of food intake, food choice and encouragement of physical activity among the broader population.

VR technology could be used to complement motivational interviewing, assess emotional states of readiness for behavioral change, and help patients to grapple with their emotional reactions to food choices. The visual presentations could assist patients in adjusting their distorted assessments of portion sizes; correcting their unrealistic expectations of the rate of weight loss; managing sensory experiences that occur as a result of behavior change, such as hunger or satiety from altered consumption patterns, or delayed muscle soreness from unaccustomed exercise; and enhancing their sense of self-efficacy by giving them successful experiences in navigating virtual environments.

VR also might be suitable for addressing adherence barriers in cardiovascular exercise rehabilitation (particularly for coronary artery disease, heart failure, and peripheral arterial disease) such as perceived exertion, anxiety, and capacity to walk to a prescribed duration and intensity. Another clinical use of VR might be in the provision of non-judgmental support for patients with various medical conditions through virtual coaches, and it might be especially suitable for housebound or reclusive individuals with social anxieties or mobility restrictions due to morbid obesity or other medical conditions. VR could be used in the therapeutic setting as a component of patient visits, to help guide and select educational materials and strategies and timelines. It might be an especially suitable modality for children, adolescents and young adults, who already are becoming familiar with VR as an entertainment technology.  VR could also be applicable to individuals with low verbal or numerical literacy who may be more oriented to pictorial (vs. written or abstract) information.

An evolving body of evidence indicates that poor sleep behaviors and insufficient sleep may be causally linked with disordered endocrine and appetite regulation and with risk of metabolic syndrome, diabetes, hypertension and clinical cardiovascular disease.  

VR technology presents new opportunities to apply recent advances in sleep research in relation to obesity and diabetes risk by objectively evaluating individual sleep and alertness status, delivering personalized guidance on healthy sleep behaviors, implementing physician-recommended treatments (e.g., positive airway pressure devices, light therapy), and assessing treatment outcomes in terms of changes in sleepiness, psycho-motor vigilance, and ocular markers of sympathetic tone.  Sleep parameters (e.g., schedules, phasing, quality and quantity), perceptive and affective aspects of sleepiness (e.g., cognizance of sleepiness, self-monitoring of sleep habits), and sleep deprivation consequences (slower reaction times and impairments in memory, cognition, emotional processing, judgment, and decision-making) are all amenable to study with VR.

VR has some unique characteristics as a research tool. The virtual environments can be designed to address specific hypotheses, and data on the study participant’s response to the intervention can be collected in high detail without additional intrusiveness. Phenomena that are amenable to study, and also treatment, include cue responsiveness and extinction through virtual exposure, a feature that has been used to advantage in treatment of phobias and addictions. Visual presentations can be tailored to the user, along with therapeutic guidance to modify affective reactions and choices, and can prepare the user for future “real-world” encounters, thus making VR suitable for role-playing and training. Performance feedback, an essential component of learning and skill acquisition, can occur in real-time; thus VR can be used as a teaching tool and also to study cognitive processing of information presented in increasingly complex (‘hierarchical”) environments, a research approach that often is not practical in “real world” settings. Also, the capability to distribute identical virtual environments across multiple locations gives new meaning to the concept of multi-site data collection.

For researchers, an advantage is that the VR approach can simultaneously deliver an intervention and collect data on how it is utilized, particularly with regard to the cognitive and emotional processes involved.  Study design and methodology challenges include: identification of appropriate control groups and control conditions, and of characteristics of rigorous efficacy and effectiveness studies of VR;  exploration of ethical issues with different types of studies such as direct comparison designs (Standard of Care (SOC) vs. VR) and additive designs (SOC vs. SOC+VR); characterization of how participant traits (such as age, literacy and numeracy level, motivation and other cognitive and psychosocial traits), and previous gaming experience moderate technology usability and study outcomes; development of well-defined metrics for assessment of interventions and outcomes, including actual as well as intended VR “dose”; development of  VR research tools that could be used in group or multi-site formats (e.g. classrooms); and development of methods for mining data from existing health games for research purposes.

SELECTED RESEARCH EXAMPLES:

There is a need for both developmental VR research leading to new methods and technologies and marketable commercial products.  There is also the need for research that provides a venue for well-powered effectiveness trials of the new interventions. Progress in the field will be enhanced by multidisciplinary collaborations between the technology industry and academia, and among researchers with diverse expertise in biomedical sciences (such as endocrinology, nutrition, and exercise physiology), behavioral science and pedagogical disciplines, and computer sciences including VR technologies.  There is a need to document and evaluate currently available off-the-shelf programs.  Projects will need to be clearly defined with regard to:  research questions, technical approach, VR platforms, target population (by age, health condition, psychological status, education or literacy level, etc), and research outcomes. Many projects can be usefully conducted taking advantage of already existing tools, games, and software, although there is also a need to develop unique technologies.
 
Applications must involve development, use or adaptation of immersive or non-immersive VR environments.  Those projects focusing only on electronic means of research data collection (so-called “e-tools”), without VR components, will not be considered responsive.

Potential areas for hypothesis-testing research, and for exploratory, developmental or evaluation research, include (but are not limited to):

Using VR to foster desirable eating, physical activity, and other health-related behaviors:

• Making smarter eating choices in various locations (such as home, restaurants, school cafeteria).
• Training for more healthful food purchasing and food use decisions (including shopping lists, budgeting, menu planning and food preparation skills).
• Counteracting food marketing efforts.
• Assisting parents in teaching small children better eating habits (e.g., eat at table, eat a variety of foods, try new foods, eat fruits and vegetables).
• Training in portion size effects on weight gain and loss.
• Retraining conditioned emotional and behavioral responses to food and eating contexts (cue-exposure of unhealthful foods or contexts where unhealthful eating behaviors occur).
• Assessing reliability and outcomes of existing “health games” or “serious games.”
• Improving self-efficacy by VR-guided practice of desired behaviors, including role-playing, scenario navigation, and presentation of information matched to individual learning style and motivational factors.
• Evaluating genetic/familial influences on perception of portion size and other visual dimensions of food availability/appearance in relation to food choices, caloric intake, and satiety.
• Evaluating and modifying sleep patterns and behaviors, especially in relation to diet, physical activity, and other aspects of obesity and diabetes prevention and management.

Using VR to motivate by “fast-forwarding” to the future:

• Illustrating how changes in physical activity or diet will lead to changes in weight and body size.
• Using avatars or intelligent agents to show consequences of unhealthful behavior and to model healthful behavior.
• Understanding characteristics of avatars that modify effectiveness of interventions, including the degree to which they must be sufficiently similar to how user views self.
• Modifying perception of body image and other aspects of appearance.
• Modeling effects of changes in community food choice availability and built environments on weight, physical activity, health, and illness. 

Utilizing social network capabilities of VR:

• Evaluating impact of social network systems with reward systems (points or credits) for desirable health-related behaviors (buying or eating healthful foods; engaging in regular physical activity; improving sleep habits; improving diabetes self-monitoring).
• Exploring how social context affects competitive or collaborative activities.
• Providing and evaluating family interventions.
• Evaluating usefulness of VR for social support for diabetes.

Utilizing motivational and teaching aspects of VR technology:

• Embedding obesity and diabetes education and motivation in existing VR games and systems.
• Using VR to make behavior change more reinforcing and participatory.
• Monitoring behavior and providing individualized feedback, including rewards and goal-setting.
• Understanding the cognitive processes involved in learning and applying health- and nutrition-related information.
• Understanding the short-term vs. long-term motivational aspects of VR, including attenuation of novelty, and how this influences effectiveness and adherence.
• Understanding determinants of decision processes involved with acceptance, adoption, maintenance, and other aspects of good vs. poor adherence to prevention and treatment regimens for obesity and diabetes.
• Understanding the role of external visual cues in providing reinforcement and motivation for exercise and increased daily physical activity in sedentary patients with diabetes or obesity or in patients needing cardiovascular exercise rehabilitation.
• Understanding components of cue responsiveness in diabetes and obesity management skills under environmental conditions of increasing complexity.
• Understanding cognitive processing of written vs. visual presentations of health and nutrition information in obese or diabetic patients with low print or numerical literacy skills.

Using VR to extend the availability and capacity of health care providers:

• Establishing extended classrooms for diabetes education.
• Providing less threatening and more accessible behavioral coaching for children.
• Enhancing displays and presentations of patient data for review by health care providers.
• Providing clinician training in how to counsel subjects on weight management.
• Providing training to clinicians and other health care professionals (dietitians, clinical exercise physiologists) in health behavior-related referral for obese or diabetic patients.