Subject: RFAHL-90-13-P.081790
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 16 Aug 90 08:05 EST

Hello,
   This is the second of four items from the 8/l7/90 NIH Guide.  Please
post this one as: RFAHL-90-13-P.081790
    Thanks.
           Dottie
 ---------------------------- Text of forwarded message -----------------------
 
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.