Background

Diet and physical activity are lifestyle and behavioral factors that play a role in the etiology and prevention of many chronic diseases, such as cancer, coronary heart disease, and overweight/obesity as well as in maintaining weight loss. Accurate longitudinal data on physical activity and dietary intake patterns is also critical for understanding how these factors may impact health and functional status over the human lifespan. Therefore, diet and physical activity are assessed for surveillance, epidemiological, behavioral, and clinical research purposes. The measurement of usual dietary intake or physical activity over varying intervals or in the past, by necessity, has relied on self-report instruments. Such reports are cognitively difficult for respondents, and are prone to varying degrees of measurement error depending on the period considered, the ease of the instrument, and the characteristics of the respondents. Efforts are underway to improve methods of assessment of dietary intake and physical activity, but much research and development remains to advance the field. Furthermore, improvements in understanding and interpreting data generated by existing instruments and the concepts they address may provide insights into differences among population subgroups, external influences, and interventions designed to change or improve dietary intake and physical activity amongst other questions.

A. Dietary Assessment

Self-report dietary assessment instruments are used in a variety of research settings to estimate the consumption of individual foods or nutrients, though it is known that their ability to measure energy is especially limited. Such instruments include food records in which respondents record foods as they are consumed, detailed and standardized 24-hour recalls which query intake for the past 24-hours or previous day, food frequency questionnaires which ask individuals to report usual frequency of intake of a long list of foods over a specified time, and screeners or short food frequency instruments that target the capture of intake of one or a few foods or nutrients. Each of these self-report dietary assessment instruments has strengths and limitations.

The limitations of self-administered dietary assessment instruments pose significant challenges for all population-based dietary research, as well as for intervention and/or metabolic studies, in which stringent monitoring of overall dietary composition and energy intake is desired. Therefore, novel and improved methods and tools related to objective and self-reported measures of dietary intakes are critically needed. Researchers also need new objective recovery (e.g., doubly labeled water for energy, 24-hour urinary nitrogen) and predictive (e.g. 24-hour urinary sucrose) biomarkers for dietary constituents and foods as well as new tools, methods and technologies for obtaining biomarkers such as improved doubly labeled water protocols and alternatives to doubly labeled water for all types of dietary research.

B. Physical Activity Assessment

Until the mid-1990s, the primary focus of research and recommendations regarding physical activity was on sustained vigorous exercise. Such activity is usually obtained through purposeful, programmed behavior, such as jogging, swimming, or sports participation. Thus, the programmed nature of exercise facilitates reporting, although validation studies generally find a bias toward over-reporting. Monitoring behavior to assess sedentary, light- or moderate-intensity activities is a challenge because of the need to assess many activities of short duration that may occur as part of routine daily functions in varying contexts, e.g., transportation, occupation, household chores, as well as recreation and sport. The importance of promoting and maintaining strength, balance, and flexibility is well-known; however, little attention has been given to assessment of these types of activities.

To date, many instruments (both reported and device-based) have been developed, and some have been validated. In addition, some types of questionnaires include sources of physical activity common among certain racial/ethnic groups. However, efforts to understand how various population subgroups interpret certain constructs used in physical activity questionnaires, such as leisure time activity or moderate physical activity, are limited. Recently, technological advances have led the collection of device-measured frequency, duration, and intensity of activity using wearable monitors that can record movement, heart rate, and other physiological signals. A challenge with the use of monitors is capturing total activity to estimate energy expenditure; furthermore, without supplemental data collection, activity monitors do not capture activity context (e.g., occupation, transportation, household, recreation).

High-resolution movement signals available from current accelerometer-based devices are the basis of a variety of algorithms that seek to identify activity types, in addition to improving estimates of energy expenditure. A challenge to the physical activity field is to arrive at a consensus approach to processing the acceleration data that is becoming available from a variety of devices. Another challenge is to increase the understanding of the unique and shared aspects of reported physical activity behaviors and the movement and physiological data available from devices. More research is needed to advance the procedures for data collection, analysis, and reporting of device-measured physical activity as well as sedentary behavior.

C. Measurement Error in Diet and Physical Activity Assessment

Diet and physical activity assessments are affected by similar sources of measurement error and techniques developed for one area may be adapted or applied to the other.

Self-report of both diet and, physical activity is prone to measurement error related to challenges of memory, estimation, and bias. Such error can obscure relationships between diet/physical activity and disease risk, and may distort data used for surveillance. Recent applications of measurement error theory to dietary assessment have shown that reporting error may mask potentially important relationships with other variables. Furthermore, the demonstration of correlated errors between FFQs and 24-hour recalls has indicated the strengths and limitations of using calibration studies to correct for measurement error. With regard to physical activity, methods to evaluate measurement error and algorithms to compensate for such errors with statistical models and analytic procedures remain underdeveloped.

D. Pattern Analysis in Diet and Physical Activity

Different statistical methods have been used to characterize patterns to examine the multiple dimensions of diet and/or physical activity. The current interest in diet and physical activity patterns creates a critical need to examine the reproducibility and validity of these analysis 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 index. Similarly, for data-driven methods, additional work is needed to test the most useful categorization and treatment of input variables, the statistical methods and options used to derive patterns, and the use of statistical testing to guide pattern selection. Research is also needed to examine how the use of pattern analyses may attenuate or exacerbate measurement error issues, to investigate the cultural variation in food patterns and how food grouping may be influenced by different contexts, and to evaluate the ability to measure change in dietary patterns over time.

E. Potential for Integrated Measurement of Diet, Physical Activity, and the Built Environment

Recent advances in objective measurement of movement and location with global positioning systems (GPS), accelerometers, pedometers, cell phones, miniaturized video cameras and other devices for tracking individuals and individual behavior, along with powerful new analytical tools for exploring spatially referenced data using geographic information systems (GIS), have created a rich opportunity for the integrated measurement of environmental context and behavior. For example, combined GPS and accelerometer units are being used to measure both intensity of physical activity and the setting in which this activity occurred. Similarly, mobile phones, which incorporate GPS systems and cameras, could capture both serving size and dining locale. Despite the promise of such technological advances, and despite the strong interest in ecological models of health behavior, there continues to be a critical need for more published studies describing and validating usable tools that simultaneously incorporate the measurement of diet, physical activity, and the environment. Such studies are urgently needed to guide researchers regarding selection of appropriate tools.

Specific Research Objectives

This FOA will support research pertinent to improving the measurements of diet and physical activity through the development of better instruments, innovative technologies, and/or applications of advanced statistical/analytic techniques. Applications should be aimed at exploring and optimizing innovative combinations of device-based and self-report measures of physical activity or dietary intake in both the general population and its diverse subgroups.

Specifically, this funding opportunity is intended to support innovative research focused on assessments of dietary and physical activity patterns and the settings in which such behaviors occur, not on the determinants of these behaviors, studies of the causal association between environment and behavior, or interventions designed to modify or improve behaviors related to dietary intake or physical activity/sedentary behavior. Moreover, it is not the primary intent of this Funding Opportunity Announcement (FOA) to make minor adjustments to existing instruments (such as simply adding specific foods or activities to the already established standardized methods and questionnaires). Rather, the purpose is to promote substantive improvements in the assessment of diet and physical activity as related to public health, obesity, cancer, and chronic diseases across the lifespan.

Potential topics include, but are not limited to:

• Refine and test innovative methods of diet or physical activity assessments for use in population surveillance, epidemiological studies, and/or behavioral interventions within general populations, socio-culturally diverse populations, low-literacy respondents, individuals with physical or developmental disabilities, and/or children or other age groups;
• Develop or refine innovative methods to improve respondent self-report of diet or physical activity behavior (potential areas include non-standardized questionnaire administration or use of life-event history calendars or other recall cues to enhance retrieval of relevant information);
• Conduct validation or testing of existing instruments to assess utility in diverse populations;
• Develop or refine innovative methods to improve underreporting of energy intake among obese and overweight individuals;
• Identify factors leading to misreporting on dietary or physical activity assessment instruments;
• Develop, refine, and test analytic or statistical methods to address measurement errors in the collection of dietary and/or supplement intake data and/or physical activity data;
• Develop, refine, and test innovative methods to investigate the multidimensionality of diet and/or physical activity 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;
• Improve methods for assessing intake of alcohol and particular food constituents, such as fat subtypes, phytochemicals, herbs, spices, and other bioactive food components;
• Validate methods for measuring dietary and/or supplement intake or physical activity using appropriate reference instruments, including biomarkers, objective measures, or physiologic outcomes such as strength and fitness;
• Develop or refine new technologies for the measurement of dietary intake and/or supplement intake or physical activity and sedentary behavior;
• Conduct cognitive testing of self-reported dietary or physical activity instruments to assess respondents' abilities to answer questions, particularly in population subgroups;
• Explore psychometric properties of instruments so that questionnaire items can be developed for various groups, compared using the same metric, or be administered with innovative approaches such as computer adaptive testing methodologies;
• Explore the potential of ecological momentary analysis (EMA) techniques in the assessment of the complex, periodic behaviors of dietary intake and physical activity;
• Develop and test new methods for accurate assessment in normal elderly and elderly with cognitive impairment or dementing diseases, which might result in difficulty remembering details of dietary intake and physical activity;
• Expand and integrate the use of image-capture or direct observation, self-report, GPS, GIS and other instruments for the joint measurement of diet, physical activity, and the environments in which these activities occur. Such integrated measurement should improve the efficiency with which we can collect measures of energy balance related behavior;
• Explore new analytic methods or models that integrate multiple layers of diet and/or physical activity data.

Applications for R21 awards should describe projects that are distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Not Applicable eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Mary Evans, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578
Email: [email protected]

Richard Troiano, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6916
Email: [email protected]
(For applications that focus on physical activity)

Nancy J. Emenaker, Ph.D., R.D.N., L.D., F.A.N.D..
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: [email protected]
(For research applications for dietary biomarkers, (including new objective recovery markers) and predictive biomarkers for dietary constituents and foods)

Kirsten Herrick, Ph.D., M.Sc.
National Cancer Institute (NCI)
Telephone: 240-276-7920
Email: [email protected]
(For applications that focus on Dietary Assessment or Dietary Methods)

Rosalind Breslow, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6231
Email: [email protected]

Dr. Sarah Yoon
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Priscah Mujuru Dr.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: (301) 594-9765
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date). Thuthuy Nguyen
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8825
?Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

Judy S. Fox
?National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-4704
Email: [email protected]

Randi Freundlich, R.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.