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 301/435-0714, 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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serum lipids and lipoproteins from childhood to adulthood.  Am J Epidemiol 
133:884-399.

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