TRIAL OF ACTIVITY FOR ADOLESCENT GIRLS (TAAG) - FIELD CENTERS AND COORDINATING CENTER Release Date: January 27, 2000 RFA: HL-00-011 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 6, 2000 Application Receipt Date: April 13, 2000 PURPOSE The Division of Epidemiology and Clinical Applications (DECA) invites cooperative agreement applications for an estimated five Field Centers and one Coordinating Center to participate, with the assistance of the National Heart, Lung, and Blood Institute (NHLBI), in a collaborative multicenter study focused on physical activity of adolescent girls. The purpose of this initiative is to test the effectiveness of a coordinated school and community-based multicomponent intervention to prevent the decline in physical activity levels and cardiopulmonary fitness of girls in middle school. Applications will be invited from investigators to participate in a multicenter randomized field trial that will test an intervention designed to meet the needs and interests of middle school girls. The multicomponent intervention to be tested is a school-community linked approach, where schools and several existing community agencies will provide skills-building, supportive environments, and opportunities for participation in physical activity during and outside of the school day. The duration of the grant period will be six years for the Field Centers and seven years for the Coordinating Center. The planning phase prior to implementation will include establishing the cooperative organizational structure and collaboratively agreeing upon the protocol including the study design, intervention design, measurements, and analysis approaches. 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 Request for Applications (RFA), Trial of Activity for Adolescent Girls, is related to the priority areas of physical activity and prevention. Potential applicants may obtain a copy of "Healthy People 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations such as universities, colleges, and other eligible agencies. Foreign institutions are not eligible for receiving awards under this solicitation, and domestic applications may not include international components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Awards for Field Centers and a Coordinating Center under this RFA will not be made to the same principal investigator (PI) to ensure that data analysis is done independently of data acquisition. The same institution may apply for both a Field Center and a Coordinating Center award, but the applications for each must be separate. The title line of the face page must indicate whether the application is for a Field Center or the Coordinating Center. For Field Centers this RFA may be of interest to researchers with expertise in the areas of exercise science, behavioral sciences, health education, pediatrics, preventive medicine, cardiovascular epidemiology, or other related disciplines. Experience with multicenter collaborative studies is desirable. Experience with well-controlled school-based studies and access to middle schools and community agencies is essential. The schools may be public or parochial and need to include 6th, 7th, and 8th grade female students. For the Coordinating Center, this RFA may be of interest to researchers with expertise in the area of biostatistics, exercise science, behavioral sciences, health education, preventive medicine, pediatrics, cardiovascular epidemiology, or other related disciplines. Investigators should have experience in clinical trial study design, study coordination, data transfer and management, quality control procedures, and data analysis. Experience with multicenter collaborative studies is essential. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative agreement (U01) award mechanism. Under the cooperative agreement, the NIH assists, supports, and is substantially involved with recipients in conducting a study by facilitating performance of the effort in a partner role. Details of the responsibilities, relationships, and governance of a study funded under a cooperative agreement are discussed later in this document under the section entitled TERMS AND CONDITIONS OF THE AWARD. The total project period for an application submitted in response to this RFA may not exceed 6 years for the Field Centers and 7 years for the Coordinating Center. This RFA is a one-time solicitation. The anticipated award date is September 29, 2000. FUNDS AVAILABLE An estimated five awards for Field Centers and one award for a Coordinating Center will be made under this RFA. A maximum of $30 million (including direct and Facilities and Administration (F&A) costs) over a six-year period will be awarded for Field Centers and seven years for Coordinating Center. Approximately 70% will be apportioned to the Field Centers. For the overall study, approximately $4.5 million in total costs (direct costs and F&A) will be available for the first year, $4.42 million for the second year, $5.5 million for the third year, $5.2 million for the fourth year, $5.5 million for the fifth year, $4.0 during the sixth year, and $915,000 for the seventh year. Awards and level of support are dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NHLBI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES 1. Background a. Physical Inactivity as a Risk Factor for Cardiovascular and Other Diseases Physical inactivity has been identified as an independent risk factor for coronary heart disease (CHD) (Berlin et al, 1990, Fletcher et al. 1992, USDHHS 1996), which is the leading cause of death in the United States for both men and women (CDC, 1993, National Center for Health Statistics, 1997). A review of epidemiological studies (Powell et al, 1987) concluded that moderate to vigorous physical activity reduces risk for CHD, and that the risk for CHD is increased nearly two-fold for persons who are physically inactive, a level comparable to the relative risks associated with increased systolic blood pressure (2.1), cigarette smoking (2.5), or elevated serum cholesterol (2.4). McGinnis and Foege (1993) calculated that the attributable risk from sedentary lifestyles is 22-30% for cardiovascular deaths. The NIH Consensus Conference on Physical Activity and Cardiovascular Health (NIH Consensus Development Panel, 1996) concluded that the accumulating scientific evidence indicates that physical inactivity is a major risk factor for cardiovascular disease and that increased emphasis should be directed toward increasing children and adolescents participation. The Report of the Surgeon General on Physical Activity and Health (USDHHS 1996) emphasized that regular physical activity has important health benefits including reducing the risk of heart disease, and helping to treat and prevent high blood pressure, high cholesterol, and diabetes, and to prevent osteoporosis and colon cancer. In addition, physical activity helps control weight, reduces feelings of depression and anxiety, and promotes psychological well-being. Inactivity increases with age and is more common among women than men and among those with lower income, less education, and in minorities (USDHHS 1996, Stone et al, 1998). b. Tracking of Physiological and Behavioral Risk Factors Cardiovascular disease begins early in life and could potentially be prevented or delayed by interventions designed for children and adolescents (Berenson, 1980). Previous studies demonstrated that serum lipids (Clarke et al, 1978, Webber et al, 1971), blood pressure (Lauer et al, 1984), body composition (Clarke et al, 1993), and physical fitness (Dennison et al, 1988) track during childhood. Tracking is defined as maintenance of relative position in rank of risk factors or behaviors over time (Kelder et al., 1994). Several studies reported that physical activity behaviors tend to track (Kelder et al, 1994, Malina 1996, Kohl et al, 1998). A recent study reported that during early childhood activity patterns track, with less active children tending to remain less active than the majority of their peers (Pate et al, 1996). The CATCH Cohort Follow-up Study reported tracking of physical activity and dietary behaviors from 5th to 8th grade (Nader et al, 1999). c. Adolescents and Physical Activity Even though adolescents are more active than adults, many do not engage in recommended levels of physical activity, and participation declines with age throughout adolescence, especially in girls (USDHHS, 1996, CDC, 1997, Stone et al, 1998). Fourteen percent of teenage girls get no regular exercise twice the percentage as for boys. The proportion of adolescent girls who participate in regular vigorous physical activity declines dramatically each year they are in high school from 61% among 9th graders to 41% among 12th grade girls. In high school, enrollment for girls in daily physical education classes dropped from 41 % in 1991 to 25% in 1995. In addition, girls from families with lower income and education participate less in out- of-school organized sports or other organized activities than families from middle to higher incomes. Adolescents interests and participation in physical activity differ by gender. Often they perceive the benefits of physical activity differently, with boys listing competition and girls more often listing weight management as a reason for engaging in physical activity (CDC, 1997). Research shows that females and males have different levels of physical skills by adolescence, are interested in different types of activities, and differ in learning styles. Girls also are less likely to believe that the benefits of exercise outweigh the barriers. Girls participate less in high-risk sports than boys but generally engage in more individual activities than boys. Some of these differences may explain why the co-educational PE programs are mostly ineffective and disliked by adolescent girls (CDC, 1997). Since boys are more likely than girls to have higher perceptions of their physical activity abilities as well as physical competence, physical activity programs serving girls should provide instruction and experiences that increase their confidence, opportunities to participate in activities, and social environments that support involvement in a range of physical activities (CDC, 1997, Heath et al., 1994, Kelder et al, 1993, Luepker et al, 1996, Garcia et al, 1997, Gortmaker et al, 1999). Heath and colleagues (1994) reported from national survey data that approximately 80% of students physical activity for the day occurs outside of school PE programs. Godin and Shepard (1986) reported that among junior high students, attitudes toward physical activity, prior experience in physical activity, and current activity habits are related to the intention to exercise. In addition, social support from friends and family has been consistently and positively related to regular physical activity. Therefore, it is important to use school PE to teach behavioral skills, encourage out- of-class physical activity, enhance social support, and target the special needs of girls. In addition, it is important to provide opportunities for physical activity outside of school. Good links between schools and community programs can provide an opportunity for an intervention that addresses all these important factors. d. School and Community Guidelines for Physical Activity and Youth The Guidelines for School and Community Programs to Promote Lifelong Physical Activity Among Young People (CDC, 1997) list ten recommendations for school and community programs to promote physical activity. These include policy, environment, physical education classes, health education curricula, extracurricular activities, parental involvement, and community agency programs. Extracurricular activities include linking schools and students to community physical activity programs and developing effective systems for referring youths from schools to community agencies. Student advocacy clubs and PE classes can teach behavioral skills and promote participation in community-based organized programs of physical activity and sports. Both the CDC report (1997) and the Surgeon General’s Report (USDHHS, 1996) recommended the need for research testing the effectiveness of a coordinated school-based physical activity intervention linked to community agency programs. This RFA addresses these recommendations for research. 2. Study Design This RFA will support a collaborative, multicenter randomized field trial to test the effectiveness of a multicomponent school-based and community-linked intervention to prevent the decline in physical activity levels and cardiorespiratory fitness in middle school girls. The unit of randomization is anticipated to be the catchment area for a middle school and at least two community agencies close enough to provide programs either on the school campus (before or after regular school hours) or in facilities that can be reached easily and safely. It is estimated that thirty catchment areas will be needed for the trial to provide sufficient power for the primary outcomes. This will provide 15 intervention and 15 comparison catchment areas. In each catchment area, one middle school with approximately 120 to 140 sixth grade girls available for baseline measurements is estimated to be needed, resulting in a total of approximately 3,600 to 4,200 girls from five geographic locations across the country. It is likely that only urban/suburban schools will be able to provide the number of students needed for this trial. To assure comparability of intervention and comparison groups (given the small number of randomization units), it is assumed that randomization will occur within matched pairs of catchment areas, with matching based on demographics such as race and income. Each Field Center will need to propose three sets of matched catchment areas with one middle school in each. Three will serve as intervention sites and three as comparison sites at each Field Center. The sample size estimates in this RFA are based on effect sizes between intervention and comparison groups of a 6% difference in cardiorespiratory fitness and a 7% difference in total daily physical activity (minutes of MVPA) with respect to changes from baseline to the end of the intervention period. These effect sizes are based on a previous study with multiethnic middle school female students. It is anticipated that a cohort analysis will be the primary analysis, where only girls who provide the baseline data at sixth grade would be included in the cohort for follow-up analyses in the trial. It is anticipated that baseline measures to define the study cohort will be conducted in the schools during the spring semester of 6th grade. The interventions will be implemented for two years during 7th and 8th grades. The primary outcome measurements for the study will be in the middle to end of 8th grade. Follow-up measures will be taken in 9th grade in order to determine if the intervention has a lasting effect into high school. No TAAG interventions are anticipated during the follow-up period. Applicants may propose alternative study designs, with justification, but also should indicate how they would implement the design presented in this RFA. a. Primary Outcome Measures Two primary outcome measures might be considered for the trial: (1) cardiorespiratory fitness and (2) physical activity as measured by accelerometers or self-reported levels of participation in moderate and vigorous physical activity in-and-outside of school combined. Indices of cardiorespiratory fitness can provide an objective measure of changes in physical activity. Applicants should provide recommendations for primary outcome measures with justifications. Cardiorespiratory fitness might be measured by a submaximal exercise test such as the Physical Work Capacity 170 (PWC 170) test which is a measure of the amount of physical work that can be done at a specified heart rate (170 bpm). This test has been validated against directly measured VO2 max, is well-received by adolescents, has been used extensively, and is easily administered in a school setting. The Steering Committee will determine the exact test to be used. The Steering Committee also will develop standard safety protocols for the type of health professional or trained staff needed to be present during the cardiorespiratory fitness test. For self-reported physical activity behavior, an example of an instrument is the Previous Day Physical Activity Recall (PDPAR) Questionnaire designed by the University of South Carolina. The Steering Committee will make the choice for the instrument to measure physical activity. b. Secondary Outcome Measures Secondary endpoints should be related to other potential effects of increased physical activity or potential mediators of the intervention effect. Examples of such measures include multiple days of accelerometer readings or self-reported physical activity, levels of sedentary behaviors, height and weight, days absent from school, smoking behavior, parental physical activity patterns, depression scales, and psychosocial measures such as exercise self- efficacy. Other measures might include school-level records for increased activity levels in PE, measures of community agency involvement, changes in health education curricula, home involvement, peer/advocacy activities, and environmental/policy changes. Applicants should provide recommendations and justification for secondary questions and secondary outcome measures. Other secondary questions to be considered are as follows: o What is the relationship of smoking experimentation with physical activity and fitness levels among middle school girls? Is smoking onset influenced by the physical activity intervention? o What is the relationship of parental activity patterns to those of their adolescent daughters? Is parental activity level related to the effect of intervention? o What types of physical activity and sedentary behaviors are most likely to track in adolescent girls? What types are most influenced by the intervention? o Do adolescent girls who are overweight or obese have lower cardiorespiratory fitness levels? Do they respond differently to intervention? o What is the relationship of level of physical activity and academic performance? 3. Intervention Components It is anticipated that the multicomponent intervention to be tested will have the school as the focus but also will include out-of-school physical activity programs offered by community agencies or organizations such as YMCA, YWCA, park and recreation departments, community centers, youth clubs, and churches, industry, and HMOs. The community component will focus on linkages with two or more agencies. The intervention model to be tested will use existing organizations and schools, to enhance or refocus some of their programs. The study investigators will develop or propose appropriate modifications to existing programs for the intervention and will train the schools and community agencies to implement them. The intent is for the intervention components to be generalizable and suitable for implementation by others. The coordinated intervention components to be implemented in each of the treatment schools might address health education classes, a home-based program, student peer/advocacy clubs, physical education classes, school staff training programs, school policy and environmental changes, extracurricular activities, and community/agency programs to provide a range of appropriate sports and recreation programs both in-and-outside of school that will meet the interests of adolescent girls from diverse backgrounds and capabilities. During protocol development, the investigators will collaborate to design the intervention to be tested in all field sites. Examples of some of the possible intervention components are as follows: Community-Agency Linkages. An agency such as a community center or a parks and recreation department youth program would coordinate with the middle schools to offer programs to meet adolescent girls interests to promote a variety of physical activity programs or non-competitive and competitive sports. These could be offered in community facilities, or the agencies could conduct programs on the school campus after school hours. Physical Education Classes. The physical education curriculum could be modified and tailored to meet the needs of middle school girls (grades 7 and 8) and would be one of the components to promote physical activity during and outside of school. A modified PE curriculum could include skills development as well as instructional sessions on the importance of physical activity for all girls. The training for all the physical activity specialists might include the special focus on adolescent girls activity needs and the promotion of participation in a variety of programs outside of school if they are not currently involved. Applicants should provide documentation that PE classes for girls will be available in the schools proposed. Classroom Health Education Course. The typical health education curriculum in middle school covers 6-8 major health topics. The courses might need to be modified to include units on the importance of physical activity for adolescent girls. 4. Study Phases Phase I (24 Months.) This phase will include establishment of the Steering Committee and Subcommittee trial management structure, and the development and pilot testing of intervention components and measurement instruments. Feasibility will be assessed by pilot testing intervention components and measurement instruments in a limited number of middle schools. Also, this phase will include development of the protocol for the trial and establishment of a data management system. Evaluation of the feasibility phase will include a review of the study protocol by a Protocol Review Committee (PRC) and the NHLBI for clearance to begin the full-scale study. Phase II (44 Months.) This phase will include finalization of the manual of procedures, training, baseline data collection (Spring 2003), randomization, implementation of the interventions, end-of-intervention measurements, one year follow-up data collection, data analyses, report preparations, and close-out of the Field Centers (late Spring 2006). Phase III (4 Months for Study Centers and 16 Months for Coordinating Center.) This phase will include completion of analyses, manuscript preparation, and study close-out. The following is the anticipated measurement schedule. It is suggested that all measurements be conducted in the Spring to avoid seasonal differences in activity patterns: o Baseline Measurement Spring Semester 2003 (6th Grade) o End of First Year Measurement Spring Semester 2004 (7th Grade) o End of Intervention Measurement Spring Semester 2005 (8th Grade) o Follow-up Measurement Spring Semester 2006 (9th Grade) SPECIAL REQUIREMENTS Terms and Conditions of Award The cooperative agreement is an award instrument establishing an assistance relationship (in contrast to an acquisition relationship) between NHLBI and a recipient, in which substantial NHLBI scientific and/or programmatic involvement with the recipient is anticipated during performance of the activity. The NHLBI purpose is to support and/or stimulate the recipient’s activity by involvement in and otherwise facilitating the activity in a partner role, but avoiding a dominant role, direction, or prime responsibility. The terms and conditions elaborate on these actions and responsibilities, and the awardee agrees to these collaborative actions with the NHLBI Project Scientist toward achieving the project objectives. It is anticipated that these terms and conditions will enhance the relationship between the NHLBI staff and the principal investigator(s), and will facilitate the successful conduct and completion of the study. These agreements will be in addition to, and not in lieu of, the relevant NIH procedures for grants administration. The terms will be as follows: 1. The awardee(s) will have lead responsibilities in all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. 2. The NHLBI Project Scientist will serve on the Steering Committee, he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and the other NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g.: recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. 3. Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the principal investigators (i.e., cooperative agreement awardees) and the NHLBI Project Scientist. Meetings of the Program Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington D.C. area. 4. A Protocol Review Committee (PRC) and a Data and Safety Monitoring Board (DSMB) will be appointed by the Director of NHLBI to provide protocol review and overall monitoring of interim data and safety issues, the Steering Committee will nominate members for this Board. Meetings of the Data and Safety Monitoring Board will ordinarily be held in Bethesda, MD. The NHLBI Project Scientist shall serve as Executive Secretary to the Board. 5. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center for a collaborative database, the submittal of copies of the collaborative datasets to each principal investigator upon completion of the study, procedures for data analysis, reporting and publication, and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NHLBI Project Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee (i.e., cooperative agreement awardees). 6. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party, involvement of study resources or citing the name of the study or NHLBI support, or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI. 7. Awardees are encouraged to publish and to publicly release and disseminate results, data, and other products of the study, concordant with the study protocol and governance. However, during or within three years beyond the end date of the project period of NHLBI support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the Steering Committee and in accordance with paragraph 6. 8. The NHLBI reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NHLBI cannot concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (e) human subject ethical issues that may dictate a premature termination. 9. Any disagreement that may arise in scientific/programmatic matters (within the scope of the award) between award recipients and the NHLBI may be brought to arbitration. An arbitration panel will be composed of three members--one selected by the Steering Committee (with the NHLBI member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NHLBI, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D and HHS regulation at 45 CFR part 16, or the rights of NHLBI under applicable statutes, regulations and terms of the award. 10.These special terms of award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74, and other HHS, PHS, and NIH grant administration policy statements. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. The application should specify the approximate percentage of each minority group in the total sample in the Human Subjects Section. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the title of the proposed research, whether the application is for a Field Center or the Coordinating Center, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. C. James Scheirer, listed under inquiries, by March 6, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The title line of the face page must indicate whether the application is for the Coordinating Center or a Field Center. Budget and Related Issues Field Center applications should contain six budget periods of 12 months. Applicants should provide adequate budget justification and all applicable direct and F&A costs should be included. Estimates of staffing needs, including the principal investigators and other professional and support staff must be included. Travel costs for Steering Committee meetings, as detailed under the section on Special Requirements, must be budgeted, along with statements indicating willingness to participate in these meetings. The Field Center applications should budget for staff to conduct data entry at their center. The Coordinating Center application should include seven budget periods for 12 months. Most equipment to be used in the trial, including any data entry equipment for the Field Centers, will be purchased by the Coordinating Center and should be included in the budget. Most of the equipment costs should be in the first year’s budget period. The Coordinating Center applicants should include costs for the PRC and DSMB meetings in the Bethesda area annually. The costs should be for one day meetings for 5-6 members plus relevant Coordinating Center personnel. Applicants should budget for 4-5 Steering Committee (2 days) meetings (of 3-4 people) during both years of Phase I and two meetings per year during Phase II, and one meeting during Phase III. Costs should be included for staff to attend training. A three percent escalation per year is allowed for all grants. APPLICATIONS NOT CONFIRMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Centre 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Applications must be received by April 13, 2000. If an application is received after that date, it will be returned to the applicant without review. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NHLBI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 Affairs, NHLBI, in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria In the written comments reviewers will be asked to apply the five standard review criteria. The five standard review criteria are: (1) 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? (2) 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? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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? (5) 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? The review group will assess the scientific merit of the study and related factors, including: Field Centers o Rationale for studying physical activity in adolescent girls and for the specific population and settings proposed to be included. o Proposed study design, including eligibility criteria, measurements, methodology, intervention, and procedures proposed to assure high quality data collection. o Feasibility of the proposed project, including plans to recruit schools, agencies, and participants and plans delineating the feasibility and logistics of providing interventions to participants. o Expertise, training, and experience of the investigators and staff, including the scientific and administrative abilities of the PI and co- investigators, their potential to accomplish the proposed research goals, the time they plan to devote to the program for the effective conduct of the study, their previous experience conducting school-based research involving physical activity, and their willingness to work collaboratively with other Field Centers, the Coordinating Center, and the NHLBI. o Facilities, equipment, and organizational structure to effectively implement the proposed research. o Appropriateness of the budget for the work proposed. Coordinating Center o Understanding of the scientific, statistical, logistical, and technical issues underlying the planned multicenter study, including issues of physical activity and fitness measurements and school-based studies with students, and the leadership role in the areas of study design, statistics, logistics, data acquisition and management, quality control, and data analysis. o Adequacy of the proposed plans for acquisition, transfer, management, and analysis of data, quality control of data collection and of the intervention, and overall coordination of the study activities. o The expertise, training, and experience of the investigators and staff, including the administrative abilities of the principal investigator and co- investigators, and the time they plan to devote to the program for the effective coordination of the multicenter study. o The administrative, supervisory, and collaborative arrangements for achieving the goals of the program, including willingness to cooperate with the participating Field Centers and the NHLBI. o Facilities, equipment, and organizational structure to effectively assist Field Centers in implementing the study and in data collection procedures and in overall coordination of study activities. o Appropriateness of the budget for the work proposed. Schedule Letter of Intent Receipt Date: March 6, 2000 Application Receipt Date: April 13, 2000 Peer Review Date: June 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 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. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elaine J. Stone, Ph.D., M.P.H. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Two Rockledge Centre 6701 Rockledge Drive, Room 8134 (MSC 7936) Bethesda, MD 20892-7936 Phone: (301) 435-0382 FAX: (301) 480-1669 E-mail: stonee@nih.gov Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Centre 6701 Rockledge Drive, Room 7220 (MSC 7924) Bethesda, MD 20892-7924 Phone: (301) 435-0266 Fax: (301) 480-3460 e-mail: scheirej@nih.gov Direct inquiries regarding fiscal matters to: Carol L. Dangel Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Center 6701 Rockledge Drive, Room 7140 (MSC 7926) Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: dangelc@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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 Andersen RE, Crespo CJ, Bartlett SJ, Cheskin LJ, Pratt M (1998). Relationship of physical activity and television watching with body weight and level of fatness among children. JAMA 279:938-942. Baranowski T, Bouchard C, Bar-Or O, Bricker T, Heath G, et al (1992). Assessment, prevalence, and cardiovascular benefits of physical activity and fitness in youth. Med Sci Sports Exerc 24:S237-S247. Berenson GS (1980). CV Risk Factors In Children: The Early Natural History of Atherosclerosis and Essential Hypertension. New York: Oxford University Press. Berlin JA, Colditz GA (1990). A meta-analysis of physical activity in the prevention of coronary heart disease. Am J Epidemiol 132:612-628. Blair SN, Wood PD, Sallis JF (1994). Workshop E: physical activity and health. Prev Med 23:558-559. Centers for Disease Control and Prevention (1993). Public Health Focus: Physical Activity and the Prevention of Coronary Heart Disease. MMWR 42(35):669-672. Centers for Disease Control and Prevention (1997). Guidelines for School and Community Programs to Promote Lifelong Physical Activity Among Young People. MMWR 46(No RR-6):1-36. Clarke WR, Schrott HG, Leaverton PE, Connor WE, Lauer RM (1978). Tracking of blood lipids and blood pressure in children: the Muscatine Study. Circulation 58:626-634. Clarke WR, Lauer RM (1993). Does obesity track in childhood? Crit Rev Food Sci Nutr 33:423-430. Dennison BA, Straus JR, Mellits ED, Charney E (1988). Childhood fitness tests: predictors of adult physical activity levels? Pediatrics 82:324-330. Engstrom LM (1991). Exercise adherence in sport for all from youth to adulthood. In: P Oja, R Telema (eds). Sports For All. Amsterdam: Elsevier Science pp 473-483. Ewart CK, Young DR, Hagberg JM (1998). School-based exercise lowers blood pressure in higher-risk adolescent girls. J Health Educ 88:949-951. Fletcher GF, Balady G, Blair SN, Blumenthal J, Caspersen C, et al (1996). Statement on exercise: benefits and recommendations for physical activity programs for all Americans. A statement for health professionals by the Committee on Exercise and Cardiac Rehabilitation of the Council on Clinical Cardiology, American Heart Association. Circulation 94:857-862. Garcia AW, Sahay A, Grimes C, Henry J, Newkirk N, et al (1997). Physical fitness status of over 2800 preadolescents from a diverse high-risk population. J Appl Sport Psychol 9:S94. Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixit S, et al (1999). Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health. Arch Pediatr Adolesc Med 153:409-418. Heath GW, Pratt M, Warren CW, Kann L (1994). Physical activity patterns in American high school students. Arch Pediatr Adolesc Med 148:1131-1136. Kelder SH, Perry CL, Klepp K-I, Lytle LL (1994). Longitudinal tracking of adolescent smoking, physical activity, and food choice behaviors. Am J Public Health 94:1121-1126. Kelder SH, Perry CL, Klepp KI (1993). Community-wide youth exercise promotion: long-term outcomes of the MHHP and the Class of 1989. J School Health 63:218-223. Kohl WH, Hobbs KE (1998). Development of physical activity behaviors among children and adolescents. Pediatrics 3:S549-S554. Lauer RM, Anderson AR, Beaglehole R, Burns TL (1984). Factors related to tracking of blood pressure in children: U.S. National Center for Statistics Health Examination Survey Cycles II and III. Hypertension 6:307-314. Luepker RV, Perry CL, McKinlay SM, Nader PR, Parcel GS, et al for the CATCH Collaborative Group (1996). Outcomes of a field trial to improve children’s dietary patterns and physical activity: the Child and Adolescent Trial for Cardiovascular Health (CATCH). JAMA 275:768-776. Malina RM (1996). Tracking of physical activity and physical fitness across the lifespan. Res Q Exerc Sport 57:48-57. McGinnis JM, Foege WH (1993). Actual causes of death in the U.S. JAMA 270:2207-2212. Moore LL, Nguyen U, Rothman KJ, Cupples LA, Ellison RC (1995). Preschool physical activity level and changes in body fatness in young children. Am J Epidemiol 142:982-988. Nader PR, Stone EJ, Lytle LA, Perry CL, Osganian SK. Three-year maintenance of improved diet and physical activity: the CATCH cohort. Arch Pediatr Adolesc Med 153:695-704. National Center for Health Statistics (1997). Health, United States, 1991- 1997 and Injury. Hyattsville: NCHS Chartbook. National Heart, Lung, and Blood Institute (1994). Report of the Task Force on Research in Epidemiology and Prevention of Cardiovascular Diseases. USDHHS, PHS, NIH. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health (1996). Physical activity and cardiovascular health. JAMA 276:241- 246. Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, et al (1995). Physical activity and public health: a recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA 273:402-407. Pate RR, Baranowski T, Dowde M, Trost SG (1996). Tracking of physical activity in young children. Med Sci Sports Exerc 28:92-96. Pate RR, Ward DS, Felton G, Saunders R, Trost SG, et al (1997). Effects of a community-based intervention on physical activity and fitness in rural youth. Med Sci Sports Exerc 29:S157. Powell KE, Thompson PD, Caspersen CJ, Kendrick JS (1987). Physical activity and the incidence of coronary heart disease. Ann Rev Public Health 8:253- 287. Raitakari OT, Porkka KV, Taimela S, Telama R, Rosanen L, et al (1994). Effects of persistent physical activity and inactivity on coronary risk factors in children and young adults: the CV Risk in Young Finns Study. Am J Epidemiol 40:195-205. Resnicow K, Robinson TN (1997). School-based cardiovascular disease prevention studies: review and synthesis. Ann Epidemiol 7:S14-S31. Robinson TN (1999). Reducing children’s television viewing to prevent obesity. JAMA 282:1561-1567. Stone EJ, Baranowski T, Sallis JF, Cutler JA (1995). Review of behavioral research for cardiopulmonary health: emphasis on youth, gender, and ethnicity. J Health Educ 26(2 suppl): S9-S17. Stone EJ, McKenzie TL, Welk GJ, Booth ML (1998). Effects of physical activity interventions in youth: review and synthesis. Am J Prev Med 15:298- 315. U.S. Department of Health and Human Services (1996). Physical Activity: A Report of the Surgeon General. Atlanta, GA: USDHHS, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion. U.S. Department of Health and Human Services (1991). Healthy People 2000: promotion and disease prevention objectives. Washington: U.S. Govt. Printing Office, 1991 DHHS Publication No.: PHS 93-1232. Webber LS, Srinivanson SR, Wattigney WA, Berenson GS (1991). Tracking of serum lipids and lipoproteins from childhood to adulthood. Am J Epidemiol 133:884-399.


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