kristoff@GENBANK.BIO.NET (Dave Kristofferson) (08/16/90)
NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS POLICY AND GUIDELINES RFA: HS-90-01 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research Application Receipt Date: October 15, 1990 AUTHORITY AND PURPOSE Under authority of Section 487 of the Public Health Service (PHS) Act as amended (42USC 288), the Agency for Health Care Policy and Research (AHCPR) awards National Research Service Award (NRSA) institutional grants (T32) to eligible institutions to develop or enhance research training opportunities for qualified individuals of the institution's selection who seek to prepare for careers in health services research. The purpose of these awards is to assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain experience in applying research methods to the systematic analyses and evaluation of health services. Individuals are selected by institutions on the basis of a demonstrated interest and relevant background in health services research. Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program as is the following Catalog of Federal Domestic Assistance number: 13.226. LEVELS OF TRAINING Applicants may apply for support for predoctoral students, postdoctoral students or a combination. Applicants should include a rationale for their choice of supporting type(s) of students. Research training should provide the conceptual and methodological foundation for investigating some or all of the following health care areas: o Primary care issues, including the development of techniques to measure the effectiveness of managing health care conditions. o The appropriateness and effectiveness of alternative treatments in terms of patient outcomes and use of services. o Factors affecting the dissemination and assimilation of information on health care technologies and other aspects of clinical practice. o Medical malpractice and liability. o Delivery of health services in rural areas. o Availability, accessibility, and quality of care for low-income groups, minorities, and the elderly. o Cost-effectiveness and cost-benefit analysis, including the allocation of health care resources and relationship to health status. o Alternative delivery systems, providers, and practice patterns in primary care. o Organizational structure, resource use, and costs of care for persons with HIV-related illnesses. APPLICANT ELIGIBILITY REQUIREMENTS Domestic nonprofit private or public institutions may apply for grants to support research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. GENERAL PROVISIONS NRSAs may not be used to support studies leading to the M.D. or other similar professional degrees, or to support residencies, i.e., postgraduate training for dentists providing health care directly to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the NRSA may support such research training if the trainee has shown a clear interest in a research career. Trainees are required to pursue their research training on a full-time basis. Because of the close relationship between teaching and research in the academic environment, trainees are permitted, with the approval of AHCPR, to teach if it can contribute meaningfully to their academic training. Teaching by trainees may not take up more than ten percent of work time during the year or exceed four hours each week. TRAINEE ELIGIBILITY REQUIREMENTS The individual to be trained must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. AHCPR NRSA awards emphasize support of multidisciplinary training. A postdoctoral student as of the beginning date of the NRSA appointment, must have a Ph.D., M.D., or other doctoral degree, or an equivalent degree from any accredited domestic or foreign institution. It is acceptable if an authorized official of the degree-granting institution certifies that all requirements for the doctoral degree have been met. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of the NRSA appointment and must be enrolled in a program leading to a Ph.D., Dr. P.H., or equivalent degree. Individuals working toward a medical degree, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their medical degree are eligible for support. NRSA Awards may not however, support study leading to the M.D. degree; neither may they support residency training. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is acceptable. Individuals with a research doctoral degree (Ph.D. or equivalent) may be appointed to the training grant. RECRUITMENT AND APPOINTMENT OF MINORITY TRAINEES The primary objective of this NRSA program is the preparation of qualified individuals for careers in health services research. Within the framework of the program's commitment to excellence and projected needs for investigators in particular areas of health services research, it is important that attention be given to recruiting individuals from minority groups that now are underrepresented nationally in health services research. Information on plans for the recruitment of trainees should include a description of efforts to recruit individuals from underrepresented minority groups. Renewal applications should include cumulative information on the subsequent career development of all trainees, including information about their minority status. PAYBACK PROVISIONS Trainees must sign an agreement that they will fulfill the NRSA payback requirements. Recipients agree to engage in health services research and/or teaching for a period equal to the period of NRSA support in excess of 12 months. Once an individual has had 12 months of postbaccalaureate NRSA support, all subsequent NRSA support is subject to payback. Recipients must undertake the obligated service on a continuous basis within 2 years after termination of NRSA support. Individuals who fail to fulfill their obligation through service must pay back the total amount of NRSA funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the service requirements and explain them carefully to prospective training candidates before an appointment at the institution is offered. PROGRAM STRUCTURE An applicant may request as many postdoctoral or predoctoral trainee positions as the proposed program can accommodate. However, training programs with fewer than five positions for postdoctoral trainees over the five-year period will not be funded. The program should be structured in such a way that acceptance of new postdoctoral trainees be limited to the first three years of the five-year award, i.e., as a minimum, two trainees the first year, another two the second year, and one the third year. A similar pattern is to be proposed by applicants requesting more than five positions. Ultimately, the number of positions awarded will be decided by the review process, program needs, and availability of funds. The AHCPR will not fund more than one training grant from the same institution. STIPENDS AND OTHER TRAINING COSTS For predoctoral individuals at all levels of experience, the stipend level is $8,500 per annum effective October 1, 1988. For postdoctorals, the stipend for the first year of support is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical practice, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The stipend for each additional year of NRSA support is the next level on the stipend scale. Postdoctoral stipends, effective October 1, 1988, are as follows: Years of Relevant Experiences Stipend 0 $17,000 1 18,000 2 25,000 3 26,250 4 27,500 5 28,750 6 30,000 7 or more 31,500 NRSA stipends may be supplemented by an institution from non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or V.A. benefits when permitted by those programs. Under no circumstances may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree candidates who, prior to the enactment of Public Law 99-514, were able to exclude all monies received under an NRSA award from their reported income, may now exclude only course tuition, fees, books, supplies, and equipment required for attendance. Non-degree candidates, who formerly were able to exclude from stipends $300 a month for a period not to exceed 3 years, will now be required to report all stipends and any monies paid on their behalf for course tuition and fees required for attendance. These new statutory requirements became effective January 1, 1987. AHCPR is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alter the relationship between NRSA fellows, trainees, and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in any employer-employee relationship with AHCPR or the institution in which they are pursuing research training. Tuition and fees, including medical insurance, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a multi-year award (generally five years) may not exceed six percent. Trainee travel, including attendance at scientific meetings, that the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee may be requested to defray the cost of other training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Also, an indirect cost allowance based on 8 percent of total allowable direct costs, or actual indirect costs, whichever is less, may be requested. Applications from State and local government agencies may request full indirect cost reimbursement. PERIOD OF SUPPORT Institutional grants are made for competitive segments of five years and are renewable. No individual trainee may receive more than five years of total NRSA support at the predoctoral level and three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards, except under certain circumstances. Any exception to this policy requires a waiver from the AHCPR. Students requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. REVIEW PROCESS Applications will be evaluated for merit by an AHCPR initial review group (IRG). Site visits may be involved. The IRG will consider the following criteria in its review: o The goals of the proposed training program and the probability of achieving them. o The substantive content of the proposed program and its relevance to current health care concerns, including courses offered. o The qualifications and responsibilities of the program director. o The qualifications of the program's faculty, including ongoing health services research, and commitment to tracking graduates following training. o The program's ability to recruit qualified trainees. o Commitment to adequate space, curriculum time, financial support, and appropriate facilities. o Cooperation of related agencies or organizations in providing experience and research training sites for trainees. o The number and types of students for whom support is requested. o Proposed methods for monitoring and evaluating the performance of trainees as well as the overall program. o The reasonableness of the proposed budget in relation to the proposed research training. NRSA proposals requesting significant amounts of grant funds for faculty or program support costs are unlikely to be funded. Although some additional faculty may be needed, funds awarded through this program are intended to support individual trainees, not to develop or expand institutional programs in health services research. AHCPR expects to award approximately $1,000,000 for new or renewal NRSA grants. The normal deadline of September 10, 1990 is waived for the solicitation. Applications must be received at the Division of Research Grants by October 1, 1990. Late applications will be returned. Applications will be reviewed by the AHCPR, IRG, and the National Advisory Council for Health Care Policy and Research and Evaluation. In addition to the recommendations made by the initial review group, the Council will consider the applicant's plans for (and likely success in) recruitment of individuals from underrepresented minority groups into the training program. Funding decisions will be made based on the review groups' recommendations, the need for research personnel in specified program areas, and the availability of funds. REVIEW SCHEDULE NRSA training grant receipt date and review cycle for all new and competitive renewal applications is indicated below. It is designed to allow Program Directors time to recruit candidates during the fall/winter of the academic year for appointments to begin the following summer. Application Initial Review Council Earliest Receipt Date Meeting Meeting Award October 15 February May/June July 1990 1991 1991 1991 ADDITIONAL INFORMATION Effective July 1, 1990, all competing NRSA institutional training grant applications must include a description of formal or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. This announcement was published in the NIH Guide for Grants and Contracts, Vol. 18, No. 45, December 22, 1989. The AHCPR expects to fund approximately five new and/or renewal institutional training awards in response to this RFA. For additional information, including the grounds for approving extensions of support and payback provisions, please refer to the announcement in the NIH Guide for Grants and Contracts, entitled, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13 (1), dated January 6, 1984. Additional information is available in the brochure, entitled, "National Institutes of Health - National Research Service Award, Institutional Grants (T32) - April 1989". These are usually available at the applicant institution, or may be obtained by contacting the following person: Hoke S. Glover Project Officer Agency for Health Care Policy and Research Public Health Service Parklawn Building, Room 18-12 Rockville, MD 20857 Telephone: (301) 443-3091 APPLICATION PROCEDURES Application should be made on Grant Application Form 398 (Rev. 10/88). This revision, which replaces Training Grant Application Form PHS 6025-1 (Rev. 1/83), contains special instructions for institutional NRSAs. Application forms are usually available at institutional offices of sponsored research or their equivalent. If not available locally, send a request accompanied by a self-addressed mailing label to Mr. Hoke S. Glover at the above address. An original and four copies of the application are to be mailed to the Division of Research Grants in accordance with the instructions in the application kit. Insert the title and number of this RFA on line 2 of the application face page. The RFA label (found in the 10/88 revision of application form PHS 398) must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of your application such that it will not reach the review committee in time for review. Two information copies should be sent to: Hoke S. Glover Parklawn Building, Room 18-12 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3091 Please notify the following person of your intentions to submit an application and contact for additional information: Hoke S. Glover Parklawn Building, Room 18-12 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3091 REQUEST FOR RESEARCH COOPERATIVE AGREEMENT APPLICATIONS RFA: HL-90-13-P CHILD AND ADOLESCENT TRIAL FOR CARDIOVASCULAR HEALTH: COORDINATING CENTER P.T. 34; K.W. 0715040, 0745035, 0755015, 0755018, 0403001 NATIONAL HEART, LUNG, AND BLOOD INSTITUTE Application receipt date: November l3, 1990 PURPOSE The Division of Epidemiology and Clinical Applications (DECA) invites cooperative agreement applications for a Coordinating Center to participate with field centers, with National Heart, Lung, and Blood Institute (NHLBI) assistance, in a collaborative study entitled "Child and Adolescent Trial for Cardiovascular Health" (CATCH). The overall objective of the trial is to assess the effects of a school- based intervention for promoting healthful behavior in elementary school children to reduce their subsequent cardiovascular disease risk. CATCH is currently in the last year of a 3.5 year feasibility study that involves protocol writing and developmental work and testing in elementary schools at four Field Centers across the country. The assistance mechanism used to support the current feasibility study and the proposed main trial for the CATCH study is the cooperative agreement which is similar to the traditional NIH research grant. It differs from a research grant principally in the extent and nature of NHLBI staff involvement. There is a Coordinating Center for the feasibility phase of this field trial, working in collaboration with the four Field Centers and NHLBI staff assistance. The Institute has decided to compete the Coordinating Center for the main trial. One award will be made for a Coordinating Center for the main study. DISCIPLINES AND EXPERTISE The main disciplines and expertise that are appropriate for the Coordinating Center for this research program include statistical skills and relevant experience in all aspects of clinical trials, including facets of data management and analysis and administrative skills needed for collaborative studies. In addition, appropriate access to part-time staff or consultants with expertise in child and adolescent studies, nutrition, and physical fitness is recommended. BACKGROUND General Several conferences and initiatives over the decade of the 1980's contributed to the Institute's program of school-based cardiovascular health promotion research. CATCH exemplifies the significant progress that has been made in school health education in the l980's and builds on prior research funded by the Institute. Ten investigator-initiated grants that have completed their research were reported in Health Education Quarterly (Stone, Perry, and Luepker, l989). All of the Principal Investigators involved in the feasibility phase for CATCH have participated in prior NHLBI funded school-based research and most of their programs and protocols have been adapted for CATCH. Scientific Background The rationale for health promotion and primary prevention of cardiovascular disease in youth is based on the high prevalence of the disease in developed countries, its early onset, the trends in risk factors and incidence in adults, and the findings that much of the age-related increase in risk factors are lifestyle-related and modifiable. Atherosclerosis is, to a degree, a pediatric problem, with expression of the primary risk factors of hyperlipidemia, tobacco use, and hypertension appearing at a young age. Furthermore, evidence of tracking of these risk factors from childhood to adulthood has been demonstrated. Also, precursor lesions of atherosclerosis have been observed in arterial tissues from children and adolescents. Population differences in the expression and distribution of risk factors are apparent in early childhood and are consistent with population differences in cardiovascular disease rates. The primary risk-related behaviors--a high saturated fat and high sodium diet, cigarette smoking, over-consumption of calories, and sedentariness - - are learned and established in childhood and adolescence. Elevated cardiovascular risk should be preventable through programs that target changes in risk-related behaviors through the identification and modification of psychosocial determinants of these behaviors. Much of the potential for primary prevention of cardiovascular disease depends on teaching young people new lifestyles and creating healthful environments in order to minimize the development of risk-related behaviors, risk factors, and their atherosclerotic sequelae. Toward this end, the feasibility study for CATCH was initiated to study the effectiveness of intervention approaches that include the curriculum, parental involvement, and school environment in the area of cardiovascular health promotion. Study Organization It is planned that the Coordinating Center for the main CATCH trial will be funded for 4.5 years to carry out the typical functions of a Coordinating Center which include the following: participating in revisions of the protocol and Manual of Operations; developing (with input from Field Centers), testing, and distributing forms; training Field Center staff in study procedures; developing and implementing randomization procedures; developing and implementing data transmission, editing, management, and storage procedures; developing and implementing procedures for monitoring data quality; implementing procedures for assuring adherence to the protocol; designing and monitoring quality control procedures; preparing periodic reports for the Steering Committee and the Data and Safety Monitoring Committee; assisting in arranging, and participating in, necessary meetings; developing plans and providing guidance in statistical analysis of the study data; carrying out statistical analyses; and participating in paper writing and presentations. Four Field Centers will be involved in the main study over a 4-year period. This period will include three academic school years and a limited time for final entry of data, responding to edit queries, and for orderly transmission of information about participants to school systems. It is anticipated that a main results paper will be prepared by the investigators and submitted for publication. Continued participation of as many investigators as possible throughout the analysis and paper writing phase is desirable. The Coordinating Center will support the paper writing effort with data analysis, statistical consultation, editorial and clerical tasks, and coordination of meetings, because the Field Centers will not have grant support for these tasks beyond the limited period noted above. The Steering Committee is the main governing body of the study and is composed of the Principal Investigators of the Study Centers and the Coordinating Center and the NHLBI Program Administrator. Each member has one vote. The Committee meets 2-3 times per year. All major scientific decisions are determined by vote of the Steering Committee. It is expected that the organizational structure established during the feasibility study will carry over into the main trial. A Chairman was selected during the feasibility study by the Committee members. Subcommittees of the Steering Committee, such as a Publications Subcommittee and subcommittees devoted to specific aspects of study design and execution, were established during the feasibility study. The NHLBI Program Administrator is a voting member of the Steering Committee. A Data and Safety Monitoring Committee was established at the beginning of the CATCH feasibility study by the Steering Committee to periodically review the progress of the study and evaluate results. Its functions include review and approval of each stage of the trial before subsequent phases may be started. During conduct of the trial, selected data will be privileged and, therefore, will be disclosed to the Data Safety Monitoring Committee only. The Chairman of the Steering Committee, the Director of the Coordinating Center, and the NHLBI Project Administrator has ex-officio membership. Appendix A contains a description of the study design for the main trial and brief results from the feasibility study for CATCH. The study protocol, manuals of procedures, and measurement instruments to be used in the main trial were developed during the feasibility study and are available upon request. MECHANISM OF SUPPORT It is anticipated that one award will be made under this Request for Applications (RFA) for a total amount of approximately 4.2 million dollars (including direct and indirect costs and funds for subcontracts to support nutrition data coding and laboratory analyses as indicated in the protocol that is available from Dr. Elaine Stone listed below) for 4.5 years of support. It is expected that funding will begin on or about April 1, 1991. The administrative and funding mechanism for this trial will continue to be a cooperative agreement. The major difference between a cooperative agreement and a research grant is that there will be substantial programmatic involvement of NHLBI staff above and beyond the levels regularly required for traditional program management of grants. The rationale for the need for this type of award is as follows: The complex nature of this field trial program requires the active assistance of an NHLBI staff member who has experience in coordinating collaborative and school-based intervention studies; such participation will contribute to the efficient conduct and successful conclusion of the trial. Under the cooperative agreement, a partnership relationship will exist between the recipient of the award and the NHLBI in which the performer of the activity is responsive to the requirements and conditions set forth in the RFA and agrees to accept an NHLBI staff member's assistance in the planning and implementation of the trial and analyses of data from the project. The specific terms, conditions, and arbitration procedures pertaining to the scope and nature of the interaction between the NHLBI and the awardee will be incorporated into the Notice of Grant Award. These agreements will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. The terms will be as follows: The investigators bear the primary responsibility for the design, conduct, and publications for the study. The NHLBI Program Administrator assists the Principal Investigators and co-investigators in the planning, execution, monitoring, and evaluation of the study. Staff involvement is defined as cooperation with the Principal Investigators and key project personnel through all phases of the study. Involvement of an NHLBI staff member is implemented primarily by membership of the Program Administrator or designee on the Steering Committee and key subcommittees and ex-officio membership on the independent Data and Safety Monitoring Committee. The purpose of having the staff member on these committees is to contribute to protocol development, protocol monitoring and execution, data analysis, and interpretation. The Program Administrator will continue to participate in further development of the interventions and procedures for ensuring general adherence to protocol. Major problems in these areas may necessitate consultation with the Steering Committee on the continued participation of one or more Centers because of insufficient school cooperation or other mutually identified concerns, and either the NHLBI Program Administrator or the investigators may also bring such issues to the Data and Safety Monitoring Committee. The NHLBI Program Administrator will act to assist the Steering Committee in decisions on publications of findings and study interpretation, recognizing that those results are not primarily for government benefit or use. The Data and Safety Monitoring Committee (DSMC) was selected by the Steering Committee during the feasibility study and comprises 7 members and makes recommendations to the Investigators and the NHLBI. The Committee members represent expertise in school-based research, cardiovascular research, behavioral science, pediatrics, cardiology, nutrition, physical fitness research, smoking research, epidemiology, and biostatistics. In the unexpected event that the NHLBI raises the option to halt the study if objectives are not being met or have been met prior to the end of the scheduled period, or makes similar decisions with major programmatic implications, an arbitrator will review any disagreements between the NHLBI and investigators involved and render a judgment on that issue. The arbitrator will be chosen by the DSMC. This arbitration process in no way affects the right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. Cooperative agreements are subject to the same administrative requirements as grants and all pertinent DHHS, PHS, and NIH grant regulations, policies, and procedures are applicable. Business management aspects of these cooperative agreements will be administered by NHLBI Grants Management staff in accordance with DHHS, PHS, and NIH grants policy. REVIEW PROCEDURES AND CRITERIA General Considerations The Principal Investigator of the Coordinating Center should be a scientist with experience in directing a coordinating center for one or more multicenter collaborative trials. There should be specific evidence cited of success in dealing with the problems of obtaining cooperation of investigators in supplying data during the extended period of clinical or field trials. Experience should also be cited of success in working out programs for assuring quality control of data from multiple and diverse centers. The Co-Principal Investigator, if proposed, should complement the skills, training, and experience of the Principal Investigator and should have had administrative experience related to a coordinating center for one or more clinical or field trials. The applicant should include in the application a succinct discussion of previous relevant investigational efforts. The Principal Investigator or Co-Principal Investigator should be a statistician with experience in the direction and/or management of a large research data coordinating center. Applicants should discuss the typical functions of a Coordinating Center which include the following: working with the Field Centers and with NHLBI assistance, participating in revisions of the protocol and Manual of Operations; developing (with input from Field Centers), testing, and distributing forms; training Study Center staff in study procedures; implementing randomization procedures; developing and implementing data transmission, editing, management, and storage procedures; further development and implementing procedures for monitoring data quality; implementing procedures for assuring adherence to the protocol; preparing periodic reports for the Steering Committee and the DSMC; assisting in arranging, and participating in, necessary meetings; developing plans and providing guidance in statistical analysis of the study data; carrying out statistical analyses; and participating in paper writing and presentations. A distributive data system was implemented with the Field Centers during the feasibility study. Currently, each Field Center has the following hardware: l ITT X-tra 300 microcomputer, l Bernoulli Box II, l ITT Monitor, l HP Desk Jet printer, l 2400 Hayes Smartmodem, and l 3l00 lap top computer for nutrient data entry. The Coordinating Center currently has the following hardware: l Compaq Deskpro 386 Microcomputer with 2 EGA Monitors and 2 Bernoulli Box II, 2 2400 Hayes Smartmodem, l HP Desk Jet printer, and 3 IBM/2 286 microcomputers. The existing software includes the POP data entry, SAS, and the Nutrient Data Base System from the University of Minnesota. With respect to data entry, the applicant should discuss what distributed data entry and data management scheme should be employed, what specific functions would be de-centralized to the Field Centers, and what hardware and software might be utilized. With respect to quality control, the applicant should discuss how the responsibility for quality control monitoring would be distributed among the Coordinating Center, the Steering Committee, and the Data and Safety Monitoring Committee. Additionally, the applicants should discuss the need for and plans to carry out or subcontract for central services, i.e., for lipids, urinary sodium, and nutrition coding. Review Method Upon receipt, applications will be reviewed by NHLBI staff for their responsiveness to the objectives of this RFA. If an application is judged unresponsive at this stage, it will be returned to the applicant. All applications in response to this RFA will be initially reviewed for scientific and technical merit by a special review group that will be convened by the Division of Extramural Affairs, NHLBI, and will be subsequently reviewed by the National Heart, Lung, and Blood Advisory Council at the February 1991 meeting. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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 Criteria Applications will be judged on the scientific and technical merit of the application submitted and on the discussion of considerations relevant to the main trial and close-out phases of the trial. The successful applicant will be selected on the basis of scientific excellence, experience of the investigators, capability to accomplish the goals of the RFA, and a demonstrated willingness to collaborate with the Field Centers and with NHLBI staff assistance. Criteria for review of applications will include the following: 1) Qualifications, experience, and commitment of key personnel including: o scientific and administrative abilities of the Principal Investigator and other team members (the Principal Investigator or Co- Principal Investigator should be a statistician); o experience of the investigators, other key personnel, and/or consultants in statistical, data management, and administrative aspects of multicenter trials, including the cardiovascular, nutrition and nutrition coding, and behavioral areas; o ability to devote adequate time to the effective conduct of the study; o willingness to work collaboratively with the Field Centers, central laboratories, and with NHLBI staff assistance in the manner summarized in the RFA; and 2) Understanding of the scientific objectives of the program, as evidenced by discussion of data analysis and by innovative and creative proposals for data management and coordination of the study including: o adequacy of plan for collection, processing, analysis, and reporting of data for the type of data entry system proposed; and o adequacy of the management plan for day-to-day operations, including interactions with the Study Centers and program office. 3) Adequacy of facilities and supportive environment, including space and equipment for the work proposed, and evidence of institutional support for participation in a long-term collaborative program. 4) Appropriateness of the budget for the work proposed. Each applicant should submit an adequately justified budget for each 12-month period for 4.5 years of support. Estimates of staffing needs including the Principal Investigator and the other professional, technical, and support staff should be submitted. METHOD OF APPLYING Letter of Intent Prospective applicants are asked to submit a one-page letter of intent. The Institute requests such letters only for the purpose of providing an indication of the number and scope of applications to be received and, therefore, usually does not acknowledge their receipt. A letter of intent is not binding, and it will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for applications. This letter of intent, which should be received no letter than October 1, 1990, should include title of the application, principal investigators, other key investigators, and their institution(s), and should be sent to: C. James Scheirer, Ph.D. Review Branch, DEA, NHLBI Westwood Building, Room 548 5333 Westbard Avenue Bethesda, Maryland 20892 Format for Applications Submit applications on form PHS 398 (rev. 10/88), the application form for the traditional research-project grant. This form is available in an applicant institution's office of sponsored research or business office or from the Division of Research Grants at NIH. Use the conventional format for research-project grant applications and ensure that the points identified in the Section on "Review Procedures and Criteria" are fulfilled. The format and instructions for budget estimates provided should be followed. Indirect costs will be awarded in the same manner as for research grants. Budgets from the applicants will be reviewed on the basis of appropriateness for the work proposed. Travel and per diem costs for two members of the Coordinating Center to attend two or three Steering Committee meetings (one in Bethesda and two at Field Centers) and one Data and Safety Monitoring Committee meeting per year in Bethesda should be included. Allowable costs and policies governing the research grant programs of the NIH will prevail. This RFA is a one-time request for applications. To identify the application as a response to this RFA, check "yes" on Item 2 of page 1 of the application and enter the title, Child and Adolescent Trial for Cardiovascular Health: Coordinating Center, RFA HL-90-13-P. Application Procedure THE RFA LABEL FOUND IN THE FORM PHS-398 APPLICATION KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COMPLETED APPLICATION FORM PHS-398. FAILURE TO USE THIS LABEL WOULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW. Submit the original signed application and four complete copies to: Division of Research Grants Westwood Building, Room 240 National Institutes of Health Bethesda, Maryland 20892** SEND TWO ADDITIONAL COPIES OF THE APPLICATION TO DR. JAMES SCHEIRER AT THE ADDRESS LISTED UNDER "LETTER OF INTENT". IT IS IMPORTANT TO SEND THESE TWO COPIES AT THE SAME TIME AS THE ORIGINAL AND FOUR COPIES ARE SENT TO THE DIVISION OF RESEARCH GRANTS, OTHERWISE THE NHLBI CANNOT GUARANTEE THAT THE APPLICATION WILL BE REVIEWED IN COMPETITION FOR THIS RFA. Applications must be received by November l3, 1990. An application not received by this date will be considered ineligible and will be returned to the applicant. Timetable Letter of Intent: October l, 1990 Application receipt date: November l3, 1990 Review by the National Heart, Lung, and Blood Advisory Council February, 1991 Anticipated award date: April 1, 1991 Inquiries Inquiries regarding this announcement may be directed to the program administrator: Elaine J. Stone, Ph.D., M.P.H. Prevention and Demonstration Research Branch Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 7550 Wisconsin Avenue Bethesda, Maryland 20892 Telephone: (301) 496-3503 APPENDIX A RESEARCH OBJECTIVES AND SCOPE The protocol and strategies for the study were developed during the planning phase. The following sections provide a summary of a research plan for the main trial as well as information about the feasibility study. Study Design for Main Trial The proposed study design is that of a randomized intervention trial of elementary school students. There will be two study groups, an Intervention Group and a Control Group. The Intervention Group will receive a school-based program consisting of the CATCH curriculum, the physical education program, the school food service program, and programs to establish smoke-free schools. One-half of the Intervention Group will receive the same school-based program plus a family-based program. The Control Group will receive the usual health curriculum of the control schools but none of the CATCH interventions. The CATCH interventions will be delivered in grades three through five. Serum cholesterol change between the third and fifth grades will be the primary endpoint. This endpoint was chosen because it is an objective index of dietary fat change, is itself an important cardiovascular disease risk factor, and its measurement procedures are well defined and suited for a population-based study. Specifically, the study will evaluate the hypothesis that children in the intervention schools, in comparison with those in the control schools, will demonstrate at follow-up an average total blood cholesterol level that is at least 5 mg/dL lower, after adjustment for baseline values. Assuming l00 students per school in the target population and adjustments for non-participation, power to detect this difference should be approximately 90%. The unit of randomization will be the elementary school. Schools will be recruited for participation and then randomly assigned to the study groups. It is proposed that 24 schools will be recruited from each of the four participating Field Centers for a total of 96 schools. In each center, ten of the 24 schools will be assigned to the control group and the remaining 14 will receive the interventions. Among the 14 intervention schools in each study center, seven will be randomly assigned to the school-based intervention alone and seven will be assigned to receive the combination of the school-based intervention and the family component. Several psychosocial, behavioral, and physiological outcomes will be secondary endpoints: health knowledge, self-efficacy, and behavioral skills that relate to the adoption and maintenance of cardiovascular health behaviors; dietary fat intake; dietary sodium intake; time engaged in moderate to vigorous physical activity; and systolic blood pressure. The hypotheses that will be examined are that children in the intervention schools, in comparison with those in control schools, will demonstrate the following: (1) Increased health knowledge, self-efficacy, and behavioral skill scores for cardiovascular health behaviors related to diet, physical activity, and smoking as measured by psychosocial assessments. (2) Reduced dietary fat intake reflected in 24-hour recall values. (3) Reduced dietary sodium intake as reflected by changes in overnight urine measures. (4) A higher proportion of children who engage in a desirable level (210 minutes per week or more) of moderate to vigorous physical activity (activity in which pulse rate exceeds 140 beats/minute). (5) Reduced systolic blood pressure. Another goal of the study will be to determine whether the family component of the intervention adds substantially to the efficacy of the CATCH school-based intervention. To address this goal, two versions of the intervention program will be implemented: one version, the school-based intervention, will consist of the classroom curricula and school environmental modifications in physical education classes, cigarette smoking, and school food service; the other version will add a family and home-based component to the school-based program. The potential added benefit of the family component will be evaluated primarily in terms of dietary fat and sodium intake. The study includes an anti-smoking component of the intervention that will be delivered to students in the fifth grade. Because there are low prevalence rates of regular smoking among fifth grade students, the study design does not have sufficient power for the estimation of differences in actual smoking rates as an outcome variable. Therefore, follow-up at the end of the fifth grade will include the measurement of students' intentions regarding smoking in the future. Measurements of behavioral outcome and process variables will be made during each grade from three through five. Physiological measurements will occur at the beginning of grade three (baseline) and at the end of grade five. In addition to the main scientific goals of CATCH outlined above, CATCH should contribute valuable information on health promotion among youth and school-based health education. Specifically, the testing of the CATCH program in 96 schools of varying socio-economic and ethnic compositions across the United States will result in data on process and intermediate outcomes. For example, by studying the composition of school lunches prior to and following the intervention, the proposed study will demonstrate the degree by which fat and sodium can be reduced in school lunch programs in a public school setting, with simultaneous control for secular changes. Also, the study will indicate the degree of parent involvement and compliance that can be anticipated in a behavioral program in schools. With its four-site design, multiple levels of intervention, and a behavioral basis for the intervention, the CATCH study offers a unique opportunity to address implementation of a multicomponent primary prevention program in a large number of schools and measure its effectiveness. In addition, valuable epidemiological data sets will be available for the scientific community. Feasibility Study for CATCH In April l987, cooperative agreements were awarded to four Field Centers and a Coordinating Center to conduct a 3.5-year feasibility study and design the main trial. The aims of the feasibility study were to demonstrate the study centers ability to recruit schools, teachers, students, parents, and food service workers to participate in the CATCH program; to develop and implement the intervention programs; to recruit students for risk-factor screening; and to complete the physiological measurements in the school setting. The protocol was developed by the collaborative group during the first year. The first year of feasibility testing of CATCH interventions and measurements was conducted during the l988-89 school year in two public schools at each of the four Field Centers. The purpose of the feasibility work was to test the acceptability of the interventions and measurements. A total of l47l students participated, comprising approximately equal numbers of 3rd and 4th graders. Sixty-five percent of the students were White, l7% Hispanic, and l3% Black. The first intervention year focused on the 3rd and 4th grade curricula and family components as well as the food service and physical education program. The second intervention year in the schools focused on 4th and 5th grade components and other intervention and measurement components that needed to be retested after revisions. Teacher training was conducted for 22 third grade teachers and 29 fourth grade teachers, which represented l00% of the teachers for all Field Centers. The curricula designed to involve parents and children in CATCH activities at home were developed for grades 3,4, and 5. Hearty Heart Home Team 3 consists of a weekly packet to parents of 3rd graders over a five-week period. The curriculum includes home activities related to eating, exercise, and non-smoking behavior. Score cards for students to earn credit for classroom competitions are given for activities carried out in the home. During l988-89, 69% of students earned points through home activities. The 4th grade home curriculum, Stowaway to Planet Strongheart, was implemented at each site during the l988-89 school year, with 82% participation. The Eat Smart School Nutrition Program, designed for working with school food service directors and staff to produce school lunch programs that are lower in total fat, saturated fat, and sodium, was implemented in the eight CATCH schools during the l988-89 school year. Major components of the program were menu planning, food purchasing, recipe modification, food preparation, food production, and food merchandising and promotion. During the l988-89 school year, training of 50 school food service workers began with a one-day training session prior to the onset of the school year and continued with regular meetings throughout the year. The program was very well accepted by food service workers. There was no decrease in school lunch participation rates and minimal, if any, increase in costs associated with the program. Nutrient content was determined by computer analysis for recipes following CATCH modifications and compared with the nutrient content of the same recipes prior to such modifications. Blood samples were obtained from l045 children during risk-factor screening. Permission for blood samples was obtained for 76% of students participating in CATCH. Eighty percent of the students participated in the other physiological measurements. Centralized training was conducted for the risk-factor measurements. The programs of the Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, are identified in the Catalog of Federal Domestic Assistance, Numbers 13.837-13.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review.