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.
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