Key Dates

Related Announcements

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this NOSI is to invite investigator-initiated applications addressing approaches that improve the measurement of diet, physical activity, sedentary behavior, and sleep and their environmental influences through the development of improved methods (e.g., device-based, self-report, or other innovations). Such instruments should be based on innovative technologies (including advanced statistical and computational and/or analytical approaches), and/or integration of measurements across multiple behaviors (e.g., consumption, sleep, sedentary and active time). Applications that explore and optimize innovative combinations of instruments across these behaviors are encouraged, as are efforts to develop combined measures of perceived and objective or physical features of the physical environments in which they occur. Studies addressing infants and young children (birth to 5 years) and individuals from underserved subgroups are especially encouraged, although all populations are eligible for study under this notice.

Background

Components of energy balance, including diet, physical activity, sedentary time, and sleep have both direct and indirect effects (via their associations with obesity) on the risk of developing diabetes, cardiovascular disease, certain cancers, and other deleterious conditions and diseases. Childhood and adult obesity rates have been steadily increasing over the last several decades, adherence to dietary and physical activity guidelines are moderate and largely unchanged during this same time period, and technological, environmental, and other societal changes are contributing to increased levels of sedentary behavior, reduced sleep time and quality, irregular sleep schedules, and poor dietary quality. Together these trends highlight the need for improved measurement of diet, physical activity, and sleep related variables. Although a variety of interviewer-administered and self-reported instruments are available across the lifespan, challenges still exist. Additionally, while there has been a proliferation of digital health technologies assessing physical activity, sedentary behavior, and sleep, there is a need for validation of these technologies as well as methods for analyzing data produced by these devices. These issues are especially challenging and understudied in children 5 years and younger as well as individuals with disabilities. To appropriately assess the influence of diet, physical activity, sedentary, and sleep behaviors across the lifespan, age-appropriate, validated assessment methods (starting at birth) are needed.

Birth to 5 Years

Assessment of Caregiver-Child Interaction and Context

Research suggests that diet, physical activity, and sleep habits are formed early in life and can shape behavioral trajectories across the lifespan. Given the dependence of young children on their primary (e.g., mothers, fathers, legal guardians) and secondary caregivers (e.g., grandparents, childcare providers) and the direct and indirect influence of these caregivers on their child’s behavior, research is needed to determine how best to accurately capture information on both children and their caregivers, while also decreasing the burden of this task.

Dynamism over Time

Dynamic changes in diet, physical activity, sedentary behavior, and sleep occur in the first few years of life. For example, typically developing children transition from a milk-based diet to solid foods; they acquire the basic motor skills required to roll-over, self-feed, and walk; and sleep periods become longer and more predictable. Furthermore, play becomes a key part of children’s activity, and it contributes to cognitive, physical, social, and emotional well-being and healthy development. In addition to assessing the type and quantity of multiple behaviors, validated assessment tools are needed that capture changes and context across time, including developmental stages. These changes include, but are not limited to: the progression of behavior change (e.g., introduction of new foods, timing of activities and sleep, diversity of foods and activities); how infants are fed (e.g., bottles, spoons, cups, self-feeding); changes in food characteristics (e.g., textures, flavors, combinations, repetitions); the settings in which behaviors occur (e.g., home, daycare, in transit); and methods that assess dietary intake in relation to the way infants are fed (i.e. use of hunger and satiety cues, self-feeding and self-regulation, and eating environment). For activity, measures are needed for movement types, functions such as play or learning, and the social, physical, natural and media context of such behaviors including presence of parents, other adults, peers, features of the indoor and outdoor environments, and presence and use of electronic devices such as televisions, tablets, and smartphones.

All Population Groups across the Lifespan

Measurement Error in Diet, Physical Activity, Sedentary Behavior, and Sleep Assessment

Diet, physical activity, sedentary behavior, and sleep assessments are affected by similar sources of measurement error and techniques developed for one area may be adapted or applied to another. Self- and proxy-report methods are prone to measurement error related to challenges of memory and may vary depending on the time period considered, ease of use of the instrument, and respondent characteristics. Measurement error due to biases or analytical decisions may also bias instruments. With regard to physical activity, sedentary behavior, and sleep, methods to evaluate measurement error and algorithms to compensate for such errors with statistical models and analytic procedures remain underdeveloped. Such errors can obscure relationships between these behaviors and disease risk and may distort data used for surveillance.

Pattern Analysis in Diet, Physical Activity, Sedentary Behavior, and Sleep

Different statistical methods have been used to characterize patterns to examine the multiple dimensions of diet, physical activity, sedentary behavior, and/or sleep or sleep-wake patterns. The current interest in these behaviors creates a critical need to examine the reproducibility and validity of these analytical methods. For investigator-driven methods, research is needed to test how the scoring, weighting, selection, and measurement of individual component items and modeling strategies influence the validity of the indexes. Similarly, for data-driven methods, additional work is needed to test the most useful categorization and treatment of input variables, the statistical methods used to derive patterns, and the use of statistical testing to guide pattern selection. Efforts are also urgently needed to evaluate the ability to measure change in patterns over time and to examine how the use of pattern analyses may attenuate or exacerbate measurement error issues. Specific to diet, research is needed to investigate the cultural variation in food patterns and how food grouping may be influenced by different contexts.

Integrated Measurement of Diet, Physical Activity, Sedentary Behavior and Sleep

Diet, physical activity, sedentary behavior, and sleep occur in concert over the course of daily cycles of behavior and exhibit complex correlations over multiple time scales yet research in these areas are siloed. Recent technological advances in wearables and passive measurement devices expand the potential for low-burden data collection of diet, physical activity, sedentary behavior, and sleep concurrently in individuals over the 24-hour day. Research is needed to improve integrated data collection methods that can build more robust data sets and inform modeling approaches to further understand interdependencies among multiple behaviors.

Integrated Measurement of Behaviors with their Physical and Social Environmental Influences

Recent advances in objective measurement of movement, location, and environmental context with global positioning systems (GPS), accelerometers, pedometers, cell phones, miniaturized video cameras, and other in-home and wearable devices for tracking individual behavior, along with powerful analytical tools for exploring spatially referenced data using geographic information systems (GIS), have created rich opportunities to measure behaviors and the contexts in which they occur. For example, GPS and accelerometer units can be combined to measure both intensity of physical activity and the setting in which activities occurred. A multi-sensor device approach (e.g., wearables, miniature home-based devices, and/or video sources) could help capture objective measures of sleep behaviors, lux levels, noise exposure, and other sleep environment measures. Similarly, mobile phones that incorporate GPS systems and cameras could capture both food serving sizes and dining locale. Despite the promise of such technological advances and the strong interest in ecological models of health behavior, there continues to be a critical need for more research describing and validating usable tools that simultaneously incorporate the measurement of diet, physical activity, and/or sleep and their physical and social context.

Research Objectives

The purpose of this NOSI is intended to stimulate innovative research focused on assessments of diet, physical activity, sedentary behavior, and/or sleep and the settings in which they occur with a goal of developing valid, reliable, accurate, and customizable instruments, ideally with low respondent burden, across the lifespan. Such approaches may include the use of mobile devices or other technologies. Additional priorities may include strategies to combine data from multiple methods of assessment; cognitive testing of new or improved recall methods for caregivers; and development and dissemination of statistical approaches to mitigate the effect of measurement error.

Applications should not focus on the underlying determinants of these behaviors or health outcomes, studies of the causal association between environment and behavior, or interventions designed to modify or improve behaviors related to dietary intake, physical activity, sedentary behavior, or sleep. Moreover, it is not the primary intent of this NOSI to make minor adjustments to existing instruments (such as simply adding specific foods or activities to already established standardized methods and questionnaires). Rather, the purpose is to promote substantive improvements in the assessment and integration of diet, physical activity, sedentary behavior, and/or sleep as related to public health, obesity, cancer, and chronic disease risk across the lifespan. Research using animal models would not be appropriate for this NOSI.

Research encouraged through this NOSI includes, but is not limited to studies that:

Birth to 5 years

• Improve or develop tools to capture differences, including cultural differences, in mixed feeding (i.e., consuming both human milk and infant formula, but not complementary foods and beverages) practices, e.g., feeding expressed human milk by bottle vs. from the breast, and related storage practices, i.e., room temperature, refrigerated, frozen, and synchronicity between milk expression and time of feeding;
• Create or adapt tools that enhance and/or integrate the accurate proxy report by caregivers (mothers, fathers, relatives, childcare providers) of the assessment of diet, physical activity, sedentary behaviors and/or sleep for infants and young children;
• Develop and validate tools or methods for concurrent and longitudinal dietary assessment of the caregiver-infant dyad construct. In particular, measurement of human milk feeding volume, formula feeding, the diet of lactating individuals and other caregivers, and the methods, amounts and process of introducing complementary foods and beverages;
• Develop and validate objective methods and/or approaches to capture physical activity and/or sleep stages in infants and young children;
• Create or adapt tools to track eating/feeding in infants with sleep and wake times and physical activity in various settings;
• Assess the trajectories of change in diet from 0-5 and relevant assessment tools at each stage in development;

All Population Groups across the Lifespan

• Expand and integrate the use of image-capture (to aid memory or in the case of diet – estimate leftovers) with direct observation, self-report, and contextual information, including Global Positioning System (GPS), Geographic Information System (GIS), Ecological Momentary Assessment (EMA), time-markers, and other instruments for the joint measurement of diet, physical activity, sedentary behavior, and/or sleep and environments in which these activities occur. Such integrated measurement should improve the efficiency with which we can collect measures of energy balance-related behaviors in the 24-hour day;
• Incorporate sensors, scanners, or mobile phone technologies and/or other devices, with the ability to capture input from multiple users (parents, relatives, caregivers) and in multiple formats (text, audio, image, bar code scanner information);
• Refine existing digital health technologies to assess diet, physical activity and/or sleep. Improvements could include faster processing time to reduce participant burden, addition of voice-recognition software for low-literate users, or faster searching algorithms to speed selection of foods consumed or probing questions (via the web or wireless transmission);
• Improve methods for assessing sleep duration (improve accuracy of capturing onset, efficiency, wake after sleep onset, wear vs. non-wear), and sleep quality in a 24-hour day;
• Validate methods for measuring dietary intake and/or dietary supplement intake, physical activity, sedentary behavior, and/or sleep in socio-culturally diverse populations, low-literacy respondents, or individuals with physical or developmental disabilities. Use appropriate reference instruments, including nutrition biomarkers and objective measures (e.g., heart rate, respiration rate, blood pressure, strength and fitness or body temperature);
• Develop and test innovative methods of diet, physical activity, sedentary behavior, and/or sleep assessments for use in in high-risk individuals (e.g., patients with cancer, diabetes, heart disease, asthma, COPD or other chronic diseases) and those with social needs (e.g., lower SES), and unique cultural backgrounds (e.g., racial/ethnic minorities);
• Develop, refine, and test analytic or statistical methods to address measurement errors in the collection of dietary and/or supplement intake data, physical activity data, and/or sleep data;
• Develop, refine, and test innovative methods to investigate the multidimensionality of diet, physical activity, sedentary behavior, and/or sleep behaviors through pattern analyses;
• Improve methods for measuring the type of physical activity (resistance vs. aerobic) and its amount (frequency, intensity, duration), the energy cost associated with physical activity, energy intake, and energy balance;
• Develop methods to detect change in physical activity behavior patterns over time that may be related to change in functional state, especially high-risk individuals (e.g., patients with cancer, diabetes, heart disease, asthma, COPD, or other chronic diseases);
• Improve methods for assessing intake of alcohol and particular food constituents, such as fat subtypes, phytochemicals, herbs, spices, and other bioactive food components;
• Improve methods for collecting location data to define activity space and integrating such data with additional GIS and other data layer in order to better quantify exposures potentially related to diet, physical activity and sleep.

National Cancer Institute (NCI): The National Cancer Institute is interested in applications addressing approaches that improve the measurement of diet, physical activity, sedentary behavior, and sleep and their environmental influences through the development of improved instruments (device-based and self-report) across the cancer continuum.

National Heart Lung and Blood Institute (NHLBI): The mission of the NHLBI is to provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep (HLBS) diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. NHLBI is interested in applications that focus on innovative research to develop valid, reliable, accurate, and customizable instruments to assess diet, physical activity, sedentary behavior, and/or sleep throughout the life course, from infants and young children to adults and the aging population. The accurate assessment of these behaviors is fundamental to improving our knowledge of the link between these key interrelated behaviors and the prevention, treatment, and management of HLBS diseases and conditions.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD is interested in applications that focus on innovative diet, physical activity, sedentary behavior and/or sleep assessment instruments for individuals who are planning to become pregnant, are pregnant, are recently post-partum, are lactating, are a child (particularly birth to 5 years of age), are in a caregiver-child dyad relationship, have an intellectual disability or a have a physical disability (e.g., wheeled mobility device users). NICHD is also interested in instruments that additionally could capture contextual and environmental variables or could capture multiple measures of interest. However, NICHD recognizes that the primary driver of developing instruments for the populations of interest will be to lower the participant burden while increasing the accuracy of assessment; as such, this primary driver may require applicants to focus on only diet, physical activity, sedentary behavior or sleep assessment.

Responsiveness

The following types of study, several of which might be part of a clinical trial, are not responsive to the intent of this NOSI:

• Clinical trials
• Studies of animal research
• Studies on the underlying behavioral, biological, or environmental determinants of dietary intake, physical activity, sedentary behaviors, and sleep behaviors
• Studies of the causal association between environment and behavior
• Studies designed to modify or improve behaviors related to dietary intake, physical activity/sedentary behavior, and/or sleep
• Studies of minor adjustments to existing instruments (such as simply adding specific foods or activities to already established standardized methods, databases, and/or questionnaires).
• Analysis of existing datasets that are not explicitly designed to improve measurement
• Studies that evaluate the association between dietary intake or behaviors and health outcomes (See NOT-HL-19-695 and NOT-DK-19-007)

Application and Submission Information

This notice applies to due dates on or after February 5, 2022, and subsequent receipt dates through May 8, 2023. 

Submit applications for this initiative using the following funding opportunity announcement (FOA) or any reissues of these announcement through the expiration date of this notice:

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-CA-21-108” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contacts

Kirsten Herrick, PhD, MSc
National Cancer Institute (NCI)
Telephone: 240-276-5734
Email: kirsten.herrick@nih.gov

Alison Brown, PhD, MS, RD
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301 435 0583
Email: alison.brown@nih.gov

Ashley Vargas, PhD, MPH, RDN, FAND
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-6030
E-mail: ashley.vargas@nih.gov

Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)
 

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Julie A Delgado
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 3014350833
E-mail: julie.delgado@nih.gov

Maggie Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov