MECHANISMS OF PHYSICAL ACTIVITY BEHAVIOR CHANGE RELEASE DATE: June 23, 2003 RFA: CA-04-009 National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) Office of Disease Prevention (ODP) (http://odp.od.nih.gov/) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399, 93.847, 93.848 LETTER OF INTENT RECEIPT DATE: October 15, 2003 APPLICATION RECEIPT DATE: November 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to increase the knowledge base necessary to develop effective physical activity interventions in children, adolescents, adults, and older adults. Specifically, this RFA seeks to elucidate the psychosocial, environmental, and physiological factors involved in the mechanisms of physical activity behavior change to better understand the factors involved in the causal pathways that lead to physical activity behavior change. RESEARCH OBJECTIVES I. Overview Given the importance of physical activity in the etiology, treatment, and prevention of many chronic diseases (such as cardiovascular disease, some cancers, and diabetes), it is important to understand how physical activity behavior can be increased. It is particularly timely to understand the mechanisms of physical activity behavior change since the majority of the U.S. population does not meet current physical activity guidelines (U.S. Department of Health and Human Services [USDHHS], 2000), and obesity continues to increase at an alarming rate (USDHHS, 2001). Little is known about the mechanisms of change in physical activity. While current physical activity interventions incorporate behavior change theories in their development, these studies do not focus on understanding the mechanisms of change, nor do they use a multidisciplinary perspective to understand the process. Understanding the psychosocial, environmental, and physiological factors that affect the mechanisms of behavior change is necessary for developing effective intervention and to avoid wasting both time and resources on interventions, which target correlates that are not in the causal pathways of physical activity (Kraemer, Stice, Kazdin, Offord, & Kupfer, 2001). II. Identification of the problem The incidences of overweight and obesity continue to rise and have reached epidemic proportions in the U.S (USDHHS, 2001). Currently, 64.5% of the U.S. adult population is either overweight or obese, and the percentage of overweight children and adolescents has doubled and tripled, respectively, over the past 20 years (Flegal, Carroll, Ogden, & Johnson, 2002; Odgen, Flegal, Carroll, & Johnson,2002). Disparities in the prevalence of overweight and obesity exist by age, gender, race/ethnicity, and socioeconomic status (USDHHS, 2001). The overweight and obesity prevalence tend to increase with age, to be higher for women who are non-Hispanic white and for women of lower socio-economic status (USDHSS, 2001). In children and adolescents racial/ethnic disparities have been observed also. Non-Hispanic white adolescents from lower socioeconomic family have higher prevalence of overweight (USDHHS, 2001). Physical activity can be important in preventing weight gain and in decreasing weight, but few adults or children/adolescents actually achieve the recommended 30 minutes of moderate physical activity on most days of the week (15% and 20%, respectively). More children/adolescents engage in vigorous physical activity (64%) than the small proportion of adults who do (23%) (USDHHS, 2000). Disparities in the prevalence of physical activity in adults have been linked to age, gender, race/ethnicity, and socioeconomic status. Physical activity tends to decrease with age and to be lower among women, non-Hispanic white, and among those with lower socioeconomic status (Sallis & Owen, 1999). Among youth, the prevalence of physical activity is lower among girls and it is affected by socioeconomic status as well as race/ethnicity, although it is difficult to disentangle the interaction between these demographic variables (Sallis & Owen, 1999; Sallis, Zakarian, Hovell, & Hofstetter, 1996). To change these trends, it is essential to understand how physical activity behavior may be modified (i.e., to understand the mechanisms of behavior change). In addition, it is important to understand if the mechanisms of behavior change differ by age, gender, race/ethnicity and socioeconomic status. Although some studies have examined whether theory-based interventions change physical activity behavior, the components responsible for the observed change have not been clearly identified, making it difficult to develop effective interventions (Baranowski, Anderson, Carmack, 1998; Baranowski, Lin, Wetter, Resnicow, & Hearn, 1997; King, 2001; Sallis, 2001). Recent professional conferences have urged researchers to focus on understanding the mechanisms of change (1997 Cooper Institute conference entitled, "Physical Activity Intervention," and the 2001 Cooper Institute conference entitled, "Innovative Approaches to Understanding and Influencing Physical Activity"). At the 1997 conference, Baranowski and colleagues reported how little was known about the mechanisms of change in physical activity, even though theories have been used in the development of interventions (Baranowski et al., 1998). The 2001 conference focused on understanding variables that affect physical activity in an effort to identify potential mechanisms of physical activity behavior change (King, Bauman, & Calfas, 2002). However, it became apparent that few studies have focused on the causal pathways and few, if any, have used a multidisciplinary approach that integrates the psychosocial, environmental, and physiological factors associated with behavior change. In 2001, King and Sallis published an editorial in the Annals of Behavioral Medicine reiterating the same concern (King, 2002; Sallis, 2001) and a recent Institute of Medicine report also encouraged researchers to use this multidisciplinary perspective to understand behavior change (Pellmar, Brandt, & Baird 2002). III. Background Few studies have investigated the mechanisms of physical activity behavior change, and preliminary data point to conflicting results (Baranowski, et al., 1998; Calfas, Sallis, Oldenburg, & French 1997; Sallis, Calfas, Alcarz, Gehram, & Johnson 1999; Bock, Marcus, Pinto, & Forsyth, 2001; Lewis, Marcus, Pate, & Dunn 2002). A review by Baranowski and colleagues noted that inconsistent findings are common in physical activity studies (Baranowski et al., 1998). Mechanisms of physical activity behavior change have been both empirically derived (Dishman & Sallis, 1994) and theoretically hypothesized (Bandura, 1986, Prochaska & DiClemente, 1983; Prochaska & DiClemente 1994). In physical activity research, constructs derived predominantly from five major theories/models have been used to develop interventions. These theories/models are the health belief model, theory of planned behavior, transtheoretical model, social cognitive theory, and ecological models (Sallis & Owen, 1999; Marshall & Biddle, 2001). Unfortunately, efficacious intervention studies based on these theories/models provide little understanding of the mechanisms of behavior change because researchers have used a "kitchen sink" approach to intervention development. To develop theory-based interventions, researchers typically select constructs from various theories to develop their interventions. Although this process provides some degree of confirmation for these theories, it fails to identify the true mechanisms of behavior change because a random process is used to identify these constructs, the causal pathways are not stated a-priori, and the theoretical assumptions about the mechanisms of change cannot be tested since the theories are not fully implemented and multiple components of various theories are tested simultaneously. Thus, this RFA seeks to understand the mechanisms of physical activity behavior change. To understand the mechanisms, the direct and indirect causal pathways that may be operating will need to be stated a-priori and studies that can test these causal inferences are targeted by this RFA. Designing studies that test the mechanisms of behavior change will be necessary as well as using adequate statistical methods (e.g., path analysis, structural equation modeling, and hierarchical modeling). According to Lewis et al. (2002) only two published papers have used appropriate statistical procedures, such as Baron and Kenny's (1986) statistical approach, to test the mechanisms of physical activity behavior change. Thus, to summarize little has been done to understand the mechanisms of physical activity behavior change and nothing has been done to understand if the mechanisms differ by demographic characteristics (i.e., gender and race/ethnicity). Although the five theories/models (listed above) predominantly used in physical activity research may serve to elucidate the mechanisms of behavior change, researchers have focused mostly on understanding individual (e.g., cognitive and psychosocial) influences on behavior. Researchers have not typically used a comprehensive approach to elucidate the mechanisms of physical activity behavior. Researchers have not integrated external (e.g., socio-cultural and physical environment) influences and socio-structural (e.g., community, workplace/schools, policies, media information) influences to identify the psychosocial and environmental factors involved in the causal pathways to physical activity behavior change. For example, empirical evidence is accumulating to suggest that enhanced access to places for physical activity increases levels of physical activity (Kahn et al., 2002). It is important for future research to consider how this influences the mechanism of behavior change. Focusing on the psychosocial and environmental influences is the perspective that behavioral scientists have emphasized in other fields (including tobacco). However, as other fields have demonstrated, it is equally important to consider the biological factors, as individual behavior has biological underpinnings that are influenced by the social and psychological context (Pellmar et al., 2002). This multidisciplinary focus is the focus of this RFA. Genetic predisposition is expected to influence behavior and change in physical activity behavior; however, the science is not sufficiently advanced at this time to consider studying genetic predisposition as part of this RFA. Instead, researchers can study physiological phenotypes that are hypothesized to influence adoption and maintenance of an active lifestyle (e.g., obesity and fitness status). Note that this RFA focuses on understanding which physiological component affects physical activity participation. Specifically, to link what is happening at the cellular level (i.e., efficacy of mobilizing free fat acid and blood glucose) when someone exercises to, for example, positive mood and fatigue (assuming that positive mood or fatigue are both linked to voluntary participation in physical activity). Ultimately, these studies would identify the specific physiological or biological mechanisms that explain individual differences in voluntary participation in physical activity. For example, the aerobic/anaerobic process (i.e., the physiological process explaining oxygen delivery to an exercising muscle), which is linked to lactate production and concentration in the blood level (Åstrand & Rodahl, 1986), can impact physical activity adoption by affecting how people feel during and after exercise (feeling fatigued, light headed, or pain). As fitness levels increase, the aerobic/anaerobic process becomes more efficient, and it is less likely that this process will affect participation and maintenance of an active lifestyle. Finally, as there are a number of physiological differences between men and women, it is also important to study these gender differences. Understanding such physiological influences is targeted by this RFA. In addition to understanding the physiological influences associated with physical activity behavior change, this RFA also is interested in elucidating psychosocial and environmental influences. Although, all possible environmental influences are of interest for this RFA, studies will be limited in their ability to manipulate some of these components (such as governmental policies and the physical environment). As the central focus of this RFA is to understand the mechanisms of physical activity behavior change, it is much more appropriate to design studies that manipulate environmental influences in a more constrained and controllable environment such as schools and worksites. Designing controlled laboratory experiments may be better to begin to isolate the variables involved in the mechanisms of physical activity behavior change. This RFA does not expect studies to manipulate all variables that influence voluntary participation in physical activity, but researchers are expected to account for potential confounders or covariates in their analyses. For example, changes in nutritional behaviors are not targeted by this RFA but it will need to be measured, as it can be, both, a confounder or modifier of physical activity behavior. IV. Objectives and Scope The purpose of this RFA is to support studies that further the understanding of how physical activity intervention works. Specifically, the focus is in supporting studies that elucidate the causal pathways that lead to physical activity behavior change. Studies that consider the psychosocial, environmental, and physiological factors that influence the mechanisms of physical activity behavior change are of interest. The physiological and psychosocial influences that are affected by disease status are of particular interest to this RFA (e.g., weight change, obesity, shift in muscle and fat mass, physical activity capacity, resting metabolic rate, hormonal change, immune functions, depression, anxiety, and quality of life). Appropriate topics Sample topics that are appropriate for (but not limited to) this RFA are listed below. Opportunities exist for both conducting in-depth analyses of existing data and designing studies that determine the mechanisms of physical activity behavior change. Existing data. A number of existing interventions have not fully analyzed their data to understand the mechanisms of change and opportunities exist to further explore these data under this RFA. o Test the psychosocial, environmental, and/or physiological influences on the mechanisms of physical activity behavior change are appropriate as secondary data analysis. o Use appropriate statistical methods (e.g., path analysis, structural equation modeling, growth models, and hierarchical model) to analyze (or re-analyze) existing data to further understand the psychosocial, environmental, and physiological factors involved in the mechanisms of physical activity behavior change. o Conduct group analyses to identify if the psychosocial, environmental, and/or physiological influences differ by age, gender, and race/ethnicity using appropriate methods to correct for potential confounders. Mechanisms of change studies. These studies should provide the empirical knowledge necessary to develop effective physical activity programs. The following are examples of potential topics (but not limited to) that would be responsive to this RFA. o Identify the psychosocial, environmental, and physiological factors involved in changing physical activity behavior, including cardiorespiratory fitness and strength training. These studies should focus on understanding how the physiological (obesity, weight gain, cardiorespiratory fitness) and psychosocial (perceived barriers, social supports, and self-efficacy) factors interact to change behavior while considering the environmental influences. If environmental influences are manipulated, these studies should be conducted in a controlled setting (i.e., laboratory type of experiment). o Compare how the psychosocial, environmental, and physiological factors involved in the mechanisms of physical activity behavior change are affected by health status. The NCI, for example, is interested in studies that focus on the physiological (obesity, change in body composition, sudden weight gain, decrease cardiorespiratory fitness, change in aerobic/anaerobic process) and psychological changes associated with cancer diagnosis and cancer treatment strategy. NIDDK is interested in studies that evaluate the impact of physical activity behavior change on development or amelioration of insulin resistance and type 2 diabetes. o Understand if the mechanisms of physical activity behavior change differ for certain populations. For example, to elucidate if the mechanisms differ by gender as there are a number of psychosocial and physiological differences between men and women. o Determine how obesity and/or change in body weight (positive or negative) interact with the psychosocial factors to influence the causal pathways that lead to physical activity behavior change. Such studies may be conducted in a disease-free population versus a diseased population. Studies that compare these mechanisms by study population are needed. o Identify the physiological factors that may influence adoption of an active lifestyle, such as aerobic/anaerobic process, lactate production, and mobilization of energy (free fatty acid and blood glucose) in the blood and identify how these physiological factors interact with the psychosocial factors (i.e., identify the specific physiological mechanisms underlying individual differences in voluntary participation in physical activity). For example, researchers may study if body temperature, cortisol level, availability of free fatty acid and blood glucose levels during exercise affect post exercise psychological and physiological status (e.g., positive mood, feeling fatigued, light headed, etc…) and, in turn, assess of this influence physical activity participation. o Identify the socio-demographic or cultural variables that affect the mechanisms of behavior change involved in minimizing health disparities (i.e., age, gender, race/ethnicity, educational level, and socioeconomic status). o Compare how the psychosocial, environmental, and physiological factors involved in the mechanisms of behavior change differ for adoption and maintenance. o Determine the psychosocial, environmental, and physiological factors that have a direct and indirect (through change in physical activity behavior) effect on quality of life (fatigue, depression, anxiety, stress, and overall quality of life) as well as elucidate the underlying mechanisms. o Combine qualitative and quantitative methods to understand the mechanisms of physical activity behavior change. Specifically, understand the context under which certain pathways may provide greater accuracy or become operational. Such studies should focus on understanding the processes underlying behavior change at the individual or population level. o Develop and test new theories/models that integrate multiple levels of influence (e.g., individual, family, community, environmental, health policy, media, etc.) on physical activity behavior and use a multidisciplinary perspective to understand the mechanisms of physical activity behavior change. Studies may allow for the possibility of uncovering new variables and ways in which variables may be combined with existing variables to predict changes in behavior (e.g., assess whether the variables have additive or multiplicative effects). MECHANISM OF SUPPORT This RFA will use NIH R01 and R21 award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://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. FUNDS AVAILABLE The participating ICs intend to commit approximately $2,860,000 in FY 2004 to fund 6 to 9 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years for R01 and 2 years for R21. The direct costs per year will be limited to $400,000 for full scale R01 and to $100,000 for full scale R21. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious 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 Restrictions on Applications All applications should explicitly state a-priori the underlying assumptions tested, even if the project uses theories to study the causal pathways that lead to physical activity behavior change. The RFA does not require that a given theory or model be tested, but it requires that when a theory or model is employed, all relevant constructs from these theories/models be included. The RFA is not interested in studies that assess the efficacy of a "kitchen sink intervention," even if the intervention used theories in its development. This RFA is particularly interested in understanding how physiological and psychological factors interact to influence the causal pathways of physical activity. All studies should focus on understanding these influences. In addition, contextual variables should be included to control for environmental influences by either manipulating these influences or accounting for their effects, as necessary for the proposed study. Finally, all studies should measure nutritional behaviors as it can be both a confounder or modifier of behavior. Bi-Annual Meetings and Collaboration In response to the RFA, investigators will be required to participate in an investigators' meeting that will meet semi-annually in the Washington, D.C. area. Applicants must include the cost to attend two one and half day meeting in their budget. The composition of this workgroup will also be supplemented (if needed) by adding key experts (NIH experts and extramural researchers) in the area of behavior change. This workgroup will enable the exchange of scientific knowledge, sharing of expertise, development of standards for studying the mechanisms of change, tracking of progress, and identification of new research opportunities. Applicants must plan for conference calls six times a year to share results among grantees and to coordinate the semi-annual meetings. At the completion of these awards, NIH may invite applicants to present their main research findings. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Louise C. Mâsse, Ph.D. Division of Cancer Control and Population Sciences Behavioral Research Program National Cancer Institute Building EPN, Room 4076 Bethesda, MD 20892-7335 FAX: (301) 480-2087 Email: email@example.com Robert J. Kuczmarski, Dr.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd., Room 673 (MSC 5450) Bethesda, MD 20892-5450 (for express mail, use 20817) FAX: (301) 480-8300 E-mail: RK191R@NIH.GOV Deborah H. Olster, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health Bldg. 1, Room 256 One Center Drive Bethesda, MD 20892-0183 FAX: (301) 402-1150 E-mail: firstname.lastname@example.org Martina Vogel-Taylor, M.T. Office of Disease Prevention National Institutes of Health 6100 Executive Boulevard, Room 2B03 Rockville, MD 20852 Fax: (301) 480-7660 E-mail: VogelM@od.nih.gov o Direct your questions about peer review issues to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: email@example.com o Direct your questions about financial or grants management matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Plaza South, Suite 243 Bethesda, MD 20892 (For express / courier service only: Rockville, MD 20852) Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: firstname.lastname@example.org 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 RFA 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Louise C. Mâsse, Ph.D. Division of Cancer Control and Population Sciences Behavioral Research Program National Cancer Institute Building EPN, Room 4076 Bethesda, MD 20892-7335 FAX: (301) 480-2087 Email: email@example.com 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 https://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. 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 https://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 https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (https://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. 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 Receive a second level review by the National Advisory Council or Board of the relevant NIH institute. 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 the 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 the application's overall score, weighting them as appropriate for each application. The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the 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, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 15, 2004 Application Receipt Date: November 14, 2004 Peer Review Date: February/March 2004 Council Review: May/June 2004 Earliest Anticipated Start Date: July 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/ 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 "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 RFA 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm 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. Reference List Åstrand, P.-O., & Rodahl, K. (1986). Textbook of work physiology: Physiological bases of exercise. NY, McGraw-Hill Inc. Bandura, A. (1986). Social foundations of thought and action. Englewood Cliffs, NJ: Prentice-Hall. Baranowski, T., Anderson, C., & Carmack, C. (1998). Mediating variable framework in physical activity interventions: How are we doing? How might we do better? Preventive Medicine, 15(4), 298-315. Baranowski, T., Lin, L.S., Wetter, D.W., Resnicow, K., & Hearn, M.D. (1997). Theory as mediating variables: Why aren't community interventions working as desired? 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