IMPROVING DIET AND PHYSICAL ACTIVITY ASSESSMENT RELEASE DATE: October 10, 2002 PA NUMBER: PAR-03-009 (The R01 portion of this PAR has been reissued, see PAR-06-104) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Replacement R21 (PAR-06-103 funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: November 02, 2005 National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) Letter of Intent dates: January 1, 2003, September 1, 2003, May 1, 2004, January 1, 2005, September 1, 2005 Application receipt dates: February 1, 2003, October 1, 2003, June 1, 2004, February 1, 2005, October 1, 2005 Revised application dates: November 1, 2003, July 1, 2004, March 1, 2005 November 1, 2005 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The objective of this Program Announcement is to support research to improve diet and physical activity measurement through improved instruments, technologies, or statistical/analytic techniques. Proposals should be aimed at exploring the optimal combination of objective and self-report measures of physical activity or dietary intake that can capture these behaviors in both general and diverse populations. RESEARCH OBJECTIVES I. Overview 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 and coronary heart disease. Both also play a role in prevention of overweight/obesity and maintaining weight loss. Moreover, longitudinal data on physical activity and dietary intake would be especially helpful in understanding how the physical activity and dietary intake patterns over the lifespan may impact on health and functional status in later years and old age. Therefore, diet and physical activity are assessed for both surveillance and epidemiological/clinical research purposes. The measurement of usual dietary intake or physical activity over varying time periods or in the past, by necessity, has relied on self-reported instruments. Such reports are cognitively difficult for respondents, and are prone to varying degrees of measurement error depending on the time period considered, the ease of the instrument, and the characteristics of the respondents. Understanding and interpretation of instruments and the concepts they address may differ among population subgroups. The NCI, NIDDK, NIA, and NINR are interested in promoting research to: 1) improve existing instruments that seek to measure dietary intake and physical activity within diverse populations over time, 2) develop or refine new technologies for the measurement of dietary intake or physical activity, and 3) improve the statistical and analytical techniques to correct for measurement error in diet and physical activity assessment instruments. II. Background and Rationale A. Dietary Assessment Dietary assessment instruments are used in a variety of research settings in which intake of individual foods or nutrients are of interest, as well as overall energy intake. Such instruments run the gamut from food records in which respondents record all foods as they are consumed, to detailed and standardized 24-hour recalls of all food or drink ingested in the past day, to food frequency questionnaires in which individuals are asked to report usual frequency of intake of a long list of foods over a specified time period, to short screeners which ask about usual frequency of intake of a group of foods targeting a specific food group or nutrient. Each of these self-reported dietary assessment instruments is successfully used in various research or public health settings, however, each has flaws and limitations both in the amount of information obtained, the quality of the data, and the analytic techniques used to provide nutrient or food group estimates (1). Food records are used in a number of nutrition research settings to measure dietary intake over a single time period, usually three to seven days. Records require motivated, trained, and literate respondents. The strength of the food record approach is that it provides specific details on the amount and kind of food consumed. Methods for food recording have improved over time and include such innovations as electronic scales or computer entry programs. However, records have important limitations. First, there is consistent research showing that when individuals are asked to record what they eat, they modify their eating habits to make the task easier and/or to represent their diet in a more positive way. In addition, the quality of diet recording is known to decline with increasing number of days. Among many respondents there is a tendency for energy estimates from records to be lower than that required for energy balance. This indicates that such respondents are either under-eating and/or underreporting their intake. Even with accurate reporting, a diet record is not thought to represent usual intake unless it is repeated over different time periods and seasons. Twenty-four hour dietary recalls, in which a trained interviewer asks and probes respondents to report the kind and amount of all food and drink consumed the previous day, are currently used to monitor group mean intakes in the population. It is generally accepted that a single 24-hour recall does not represent usual individual intake and cannot be used to estimate population intake distributions of nutrients or food groups. Multiple recalls are required to represent usual intake of all nutrients and foods, and for nutrients and food groups that are infrequently consumed, many days are required. Methods to collect recalls vary from paper-and-pencil to computerized systems. The more highly sophisticated systems have standardized probes, multiple passes of intake over the day to prompt recall, and "forgotten foods lists." Such innovations in the recall methods have led to improvements in prompting recall and, therefore improved estimates of nutrient intake among respondents. However, recalls, like records, are prone to underreporting, although the extent of underreporting may vary by quality of the recall. Underreporting is likely due to problems involving memory, difficulty in reporting portion size, and biases of the respondents. Food frequency questionnaires (FFQs) are self-administered instruments in which respondents are presented with a long list of items and asked to report usual frequency of consumption over a specific time period (usually one year). The strengths of the FFQ method are that it is designed to obtain data regarding usual intake and is much less costly to administer and code than recalls or records. Therefore, the FFQ has been the method of choice for large-scale epidemiological studies. However, FFQs lack the detail and specificity of records or recalls. The food list found on FFQs is, by design, largely composed of frequently consumed foods. The nutrient database lacks specificity and relies on nutrient content of the most common form in which foods are consumed rather than on specific forms. Usual portion sizes are either assumed or queried in a general fashion. In addition, completing FFQs is cognitively difficult, requiring good memory and estimation skills. There are many well-developed FFQs available for use by investigators; therefore, development from scratch is not generally necessary for most research efforts. Many FFQs available today can be adapted to meet particular research needs. There have been limited efforts to adapt FFQs for culturally specific populations and there is a continuing need to adapt instruments as research in diverse and distinct socio-cultural populations expands. Extensive research has led to the general acceptance that FFQs are prone to more and/or different kinds of error than records or recalls. FFQs have commonly been calibrated with recalls or records, which are considered to be more precise. However, given that there is measurement error in all dietary assessment methods, various methods employing measurement error models and energy adjustment are used to assess validity or to adjust relative risks for disease outcomes. More recently, intake biomarkers such as doubly labeled water for energy expenditure or urinary nitrogen for protein intake have been used to better understand the structure of measurement error and to devise methods to correct for this error in epidemiological studies. The limitations of self-administered dietary assessment instruments also pose a significant challenge for dietary intervention and/or metabolic studies, especially where stringent monitoring of overall dietary composition and energy intake is required. Such studies have often opted to provide meals to the study subjects or include doubly labeled water assessments in addition to the self-report dietary measures. However these approaches are not necessarily feasible (e.g., limited availability of doubly labeled water), often entail substantial time commitment on part of the study subjects and study personnel (e.g., preparation and distribution of meals from the metabolic kitchen, travel time of the study participants to collect or eat their meals at the metabolic kitchen), and may run the risk of increasing study subject burden, thereby affecting retention and future recruitment of study subjects. In this regard, there is a critical need for objective and accurate dietary assessment instruments and methodology (e.g., new nutrient biomarkers, improved doubly labeled water protocols, and alternatives to doubly labeled water) for dietary intervention and/or metabolic studies. B. Physical Activity Assessment Until fairly recently, 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. With these characteristics, vigorous exercise is relatively easy for respondents to report, although validation studies generally find a bias toward over-reporting (2). Recent physical activity guidelines (3,4) have emphasized the accumulation of shorter episodes of moderate intensity physical activity. Moderate intensity activity can occur in many routine daily activities. Interventions to increase physical activity obtained through moderate intensity daily activities have achieved comparable physiologic outcomes to those that used more vigorous programmed activities. However, monitoring behavior to assess 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 transportation, occupation, household chores, as well as recreation and sport (5). Current guidelines also note the importance of engaging in activities to promote strength and flexibility. Maintaining strength and flexibility are important for an aging population, and may have beneficial effects for disease prevention. Little attention has been given to assessment of these types of activities. Physical activity records have been shown to be quite accurate for capturing total activity. Records can provide desired details regarding activity context, the type of activity (e.g., aerobic, strengthening, or for flexibility), as well as frequency, intensity, and duration. However, like diet records, they are burdensome to respondents, requiring responses each time there is a change in activity throughout the day. An advantage for physical activity, in contrast to diet, is that recent technological advances allow physical activity frequency, duration, and intensity to be objectively measured by wearable monitors that can record movement and/or heart rate. A challenge with the use of monitors is capturing total activity. This is because activity monitors selectively record movement of the part of the body to which they are attached. Activity monitors worn on the hip primarily capture locomotion, but not upper body movement; if worn on the wrist, locomotion is not accurately recorded. Without supplemental data collection, activity monitors do not capture activity context (e.g., occupation, transportation, household, recreation). Most evaluations of physical activity in surveillance or risk factor epidemiology rely upon retrospective questionnaire assessment. Many instruments have been developed and some have been validated. A major improvement in questionnaire assessment of physical activity was the inclusion of household sources of activity, which can be the primary context for physical activity among women. Efforts have also been made to adapt questionnaires to include sources of physical activity common among certain racial/ethnic groups. However, efforts to understand constructs implicit in physical activity questionnaires, such as leisure time activity or moderate physical activity, across various population subgroups are limited. C. Parallels Between Diet and Physical Activity Assessment There are many parallels in diet and physical activity assessment research (6). For example, assessing total physical activity is analogous to assessing total energy intake; assessing subcomponents of physical activity, such as occupational or leisure time activity, or cardiovascular or strengthening activities is analogous to assessing dietary fat or fruit and vegetable intake. Reference periods for either diet or physical activity behaviors can vary from a week to a lifetime, and may focus on recent behavior, a specific previous period, or may be recorded contemporaneously. Ideally, physical activity assessment includes type of activity and context (specified by question content or respondent), frequency of behavior, duration of behavior, and performance intensity. Estimating performance intensity or duration is similar in many ways to estimating portion size in dietary questionnaires. Respondents may not have internal reference criteria that agree with the external criteria of the investigator, and the estimates can be influenced by cultural norms or public health messages. As with diet and other self-reported behaviors, physical activity assessment is prone to measurement error. This error is related to the same challenges of memory, estimation, and bias found in dietary assessment instruments. Perhaps even more than for diet, many aspects of physical activity, especially moderate physical activity, are routine and therefore not salient enough to be recalled well by a respondent. Measurement error can obscure relationships between physical activity and disease risk, and also distorts values used for surveillance. Recent applications of measurement error theory to dietary assessment have shown that reporting error can obscure potentially important relationships. Furthermore, the demonstration of correlated errors between FFQs and 24-hour recalls have called into question the common calibration study approach. Physical activity assessment research has lagged behind diet in addressing methods to evaluate and address measurement error through statistical models and analytic procedures. It may be possible to use recent advances in addressing dietary measurement error as a basis for exploring means to characterize and handle measurement error in physical activity. III. Objectives The objective of this Program Announcement is to support research to improve diet and physical activity measurement through improved instruments, innovative technologies, or application of statistical/analytic techniques. Proposals should be aimed at exploring the optimal combination of objective and self-report measures of physical activity or dietary intake that can capture these behaviors in both general and diverse populations. Specifically, this PA is intended to support research and innovation in dietary and physical activity assessment. The focus is on the assessment of the behaviors, and not on the determinants of these behaviors. Much effort has already been put forth in the development of dietary and physical activity instruments. For example, there are highly developed standardized methods for collecting 24-hour recall data (e.g., Nutrition Data System for Research (7), USDA 5 Pass Method (8)), food frequency questionnaire data (e.g., NCI Diet History Questionnaire (9), Block FFQ (10), Willet FFQ (11)), and physical activity questionnaires (e.g., Seven-Day Physical Activity Recall, International Physical Assessment Questionnaire (12)). Given this history, it is not the primary intent of this PA to make minor adjustments to existing instruments (such as simply adding culturally specific foods or activities to an instrument). The purpose is to promote substantive work to refine or improve the assessment of diet and physical activity. Applications could include development of: novel assessment approaches, better methods to evaluate instruments, assessment tools for culturally diverse populations, across various age-groups including older adults, improved technology or applications of existing technology, or statistical methods to assess or correct for measurement error. Research topics to be supported by this PA will be those falling within areas of clear importance for assessing the administration, utility, and/or validity of collecting data to measure dietary intake or physical activity. Possible topics include: o Refine, and test methods of dietary or physical activity assessment for use in population surveillance, epidemiological studies, and/or behavioral interventions within general populations, socio-culturally diverse populations, low-literacy respondents, or specific age groups. o 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. o Develop or refine innovative methods to improve underreporting of energy intake among obese and overweight individuals. o Develop, refine and test analytic or statistical methods to address measurement error in the collection of dietary intake or physical activity assessment instruments. o Improve methods for measuring the type (resistance vs. aerobic) and amount (frequency, intensity, duration) of physical activity behavior, the energy cost associated with physical activity, energy intake, and energy balance. o Improve methods for assessing intake of particular types of food constituents, such as fat subtypes and phytochemicals. o Validate methods for measuring dietary intake or physical activity using appropriate reference instruments, including biomarkers, objective measures, or physiologic outcomes such as strength and fitness. o Develop or refine new technologies for the measurement of dietary intake or physical activity. o Conduct cognitive testing of self-reported dietary or physical activity instruments to assess respondents' abilities to answer questions, particularly in population subgroups. o Conduct validation or testing of existing instruments to assess utility in diverse populations. o Identify factors leading to misreporting on dietary or physical activity assessment instruments. o 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. o Explore the potential of ecological momentary analysis (EMA) techniques in the assessment of the complex, periodic behaviors of dietary intake and physical activity. o 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 MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Heath (NIH) research project grant (R01) or an exploratory/developmental grant (R21). Applicants will be responsible for planning, direction, and execution of the proposed project. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. The total project period for an application submitted in response to this PA may not exceed 5 years for an R01 application and 2 years for an R21 application. For R21 submissions, you may request up to $100,000 direct costs (four budget modules) per year unless your application includes consortium costs, in which case the limit is $125,000 direct costs (five budget modules) per year. The R21 grants are non-renewable and continuation of projects developed under this PA will be through the traditional unsolicited investigator initiated grant program. Applicants without extensive preliminary data or who wish to explore the utility of new dietary or physical activity assessment methods are urged to submit applications for this PA using the exploratory/developmental grant (R21) mechanism. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). Applicants may wish to coordinate efforts in developing their applications. Furthermore, applicants proposing to develop new instruments for measuring dietary intake or physical activity are strongly encouraged to build upon existing measures and instruments and to collaborate with other investigators undertaking work in these areas as a means of promoting improved methods or analytic techniques that can be shared among multiple investigators and have utility in a number of research settings. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs. SPECIAL REQUIREMENTS NCI intends to convene one or more workshops involving grantees funded under this program announcement to facilitate future planning and program direction. Grantees should provide budgets that include two two-day trips to the Washington, DC area. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. We strongly encourage investigators to go to http://riskfactor.cancer.gov/ to learn more about this PA. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Amy Subar, PhD or Richard Troiano, PhD Division of Cancer Control and Population Sciences National Cancer Institute Building EPN Room 4005 Bethesda, MD 20892 Telephone: (301) 594-0831 or 301-435-6822 FAX: 301-435-3710 Email: subara@mail.nih.gov or troianor@mail.nih.gov Susan Yanovski, MD Director Obesity and Eating Disorders Program National Institute of Diabetes & Digestive & Kidney Diseases 2 Democracy Plaza, Rm 665 Bethesda, MD 20892-5450 Telephone: (301) 594-8882 FAX: (301) 480-8300 Email: YanovskiS@extra.niddk.nih.gov Chhanda Dutta, PhD Geriatrics and Clinical Gerontology Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E-327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 435-3048 FAX: (301) 402-1784 Email: mcd23z@nih.gov Dr. Janice Phillips Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: Janice_Phillips@nih.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: crystal.wolfrey@nih.gov Ms. Sharon Bourque Grants Management Specialist Division of Extramural Affairs, NIDDK 6707 Democracy Blvd. Room 612, MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8846 FAX: (301) 480-3504 Email: bourques@extra.niddk.nih.gov Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: WhippL@nia.nih.gov Ms. Tara Mowery Office of Grants and Contracts Management National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5979 FAX: (301) 451-5650 Email: tara_mowery@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The Letter of Intent is to be sent to Dr. Richard Troiano, at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on February 1, 2003, October 1, 2003, June 1, 2004, February 1, 2005, and October 1, 2005. Revised applications will be accepted on November 1, 2003, July 1, 2004, March 1, 2005, and November 1, 2005. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the NIH program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the relevant institute staff that the institute will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member at the relevant institute who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates of February 1, 2003, October 1, 2003, June 1, 2004, February 1, 2005, or October 1, 2005. Revised applications must be received or mailed by November 1, 2003, July 1, 2004, March 1, 2005, or November 1, 2005. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Those that receive a priority score will undergo a second level review by an appropriate Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research in now available online at: http://cme.nci.nih.gov/ PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and 93.866, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. Thompson FE, Subar AF. Chapter 1: Dietary Assessment Methodology. In: Nutrition in the Prevention and Treatment of Disease, Coulston AM, Rock CL, Monsen ER (eds), Academic Press, San Diego, 2001. 2. Sallis JF, Saelens BE. Assessment of physical activity by self-report: Status, limitations, and future directions. Res Q Exerc Sport 2000; 71:1- 14. 3. US Department of Health and Human Services. Physical Activity and Health: A Report of the Surgeon General. 1996. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, GA. 4. Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, & King AC. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. 1995; J Amer Med Assoc 273:402-407. 5. Troiano RP, Macera CA, Ballard-Barbash R. Be physically active each day. How can we know? 2001; J Nutr 131:451S-460S. 6. Friedenreich CM. Physical activity and cancer: Lessons learned from nutritional epidemiology. 2001; Nutr Rev 59:349-357. 7. http://www.ncc.umn.edu/index.htm 8. AJ Moshfegh, N Raper, I Ingwersen, L Cleveland, J Anand, J Goldman, R LaComb. An improved approach to 24-hour dietary recall methodology. Ann Nutr Metab 2001; 45(suppl 1): 156. 9. http://riskfactor.cancer.gov/DHQ/ 10. http://www.nutritionquest.com/ 11. Rimm EB, Giovannucci EL, Stampfer MJ, et al. Reproducibility and validity of an expanded self-administered semiquantitative food frequency questionnaire among male health professionals. Am J Epidemiol 1992;135:1114-1126. 12. A collection of physical activity questionnaires for health-related research. Med Sci Sport Exerc 1997;29(6, Suppl), 205 pp.


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