From: kristoff@GENBANK.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 31, pt. 2, 28 August 1992
Date: 3 Sep 92 01:58:23 GMT
Distribution: bionet


$$XID RFA NIH92HL09 NIH-92-HL-09 P1O1 **********************************

OBESITY PREVENTION IN AMERICAN INDIANS/ALASKA NATIVES: COORDINATING
CENTER

NIH GUIDE, Volume 21, Number 31, August 28, 1992

RFA:  NIH-92-HL-09-P

P.T. 34, FE; K.W. 0715145, 0745027

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  October 15, 1992
Application Receipt Date:  December 18, 1992

PURPOSE

The Division of Epidemiology and Clinical Applications (DECA) invites
cooperative agreement applications for a Coordinating Center to
participate [with an estimated five Field Centers, to be solicited
under a separate Request for Applications (RFA) RFA:  NIH-92-HL-08-P,
and with the assistance of the National Heart, Lung, and Blood
Institute (NHLBI)] in a collaborative study to assess the effectiveness
of school-based intervention to prevent obesity in young American
Indians/Alaska Natives (hereafter referred to as Native Americans).
The solicitation is for the initial three-year planning and feasibility
study of a planned nine-year effort.  The purpose of this planning and
feasibility study is to test the acceptability and efficacy of
school-based interventions focused on the primary prevention of obesity
in pre-adolescent Native Americans.  The intervention is envisioned to
include elementary school curricula that may incorporate a variety of
nutrition and physical education methods, inter-generational
components, skill-building and behavioral activities, and strong family
or home-based components.  The intervention may also include
environmental changes related to food consumption and physical activity
as well as development of supporting community programs.  The planning
and feasibility phase will include collaboratively establishing the
study's design and organizational structure; developing the study
protocol; selecting and pilot testing all measurement instruments and
methods; and developing and pilot testing all intervention protocols,
materials, and methods.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Obesity Prevention in American Indians/Alaska Natives, is related to
the priority areas of nutrition, physical activity fitness, educational
and community-based programs, heart disease and stroke, and diabetes
and chronic disabling diseases.  The Healthy People 2000 objectives
specify a reduction in overweight to a prevalence of no more than 30
percent among American Indian/Alaska Native adolescents aged 12 through
19.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0) or "Healthy People 2000"
(Summary Report:  Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal Government.  Foreign organizations are
not eligible to apply and domestic applications may not include
international components.  Applications from minority individuals,
especially American Indians/Alaska Natives, and women are encouraged.

Awards for a Coordinating Center under this RFA and Field Centers under
a separate RFA will not be made to the same Principal Investigator
(PI); this is to ensure that data analysis is done independently of
data acquisition.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
project will be a cooperative agreement (U01), an assistance mechanism.
Under the cooperative agreement, the NIH assists, supports, and/or
stimulates and is involved substantially 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 sections entitled STUDY ORGANIZATION and TERMS AND
CONDITIONS OF AWARD.

FUNDS AVAILABLE

One award for the Coordinating Center will be made under this RFA.  A
maximum of $6.3 million (including direct and indirect costs) over a
three-year period will be awarded for Field Centers and the
Coordinating Center with at least two-thirds for Field Centers.
Approximately $2.0 million will be available for the first year to be
allocated among the Field Centers and Coordinating Center.

The level of support is dependent on the receipt of a sufficient number
of applications of high scientific merit.  Although this project 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.

At the end of the three-year planning and feasibility study, two
possible options will be available to awardees: (1) the NHLBI hopes to
invite competitive renewals under the Cooperative Agreement mechanism
for the six-year full-scale study, if feasibility is shown, or (2) the
awardees may submit grant applications through the usual
investigator-initiated grants program.

RESEARCH OBJECTIVES

Background

The Native American population, including American Indians and Alaska
Natives, totals nearly 1.5 million from over 500 tribes and nearly 300
reservations and Alaska Native villages.  Earlier in this century,
heart disease was rarely noted in Native Americans, but in the last
decade cardiovascular disease has become the leading cause of death in
Native Americans.  Several factors may be responsible for this
increase:  a decreasing incidence of infectious disease, an increasing
incidence of diabetes mellitus, and an increasing incidence of obesity.
Previous research on non-Indian populations indicates that obesity is
an independent risk factor for cardiovascular disease and that it is
associated with increases in other cardiovascular disease risk factors
such as high blood pressure, diabetes, and low HDL-cholesterol levels.
The high prevalence of obesity among Native Americans, coupled with its
role as a risk factor for hypertension, coronary heart disease, and
diabetes, suggests that a reduction in the average weight of young
Native Americans would improve their health.  Reduction of the
prevalence of obesity in Native Americans has been designated as a goal
for improving the health of this minority population.  Healthy People
2000 states that this objective should be achieved through emphasis on
physical activity accompanied by properly balanced dietary intake so
that growth is not impaired.  This RFA attempts to address these issues
with a project on primary prevention of obesity in young Native
Americans.  A more detailed scientific background may be found in the
appendix of this RFA.

Successful respondents to this RFA are likely to have a thorough
knowledge of data analysis and data base management, and administrative
skills and experience needed to design and monitor collaborative
intervention studies.  Expertise that may be appropriate for this RFA
includes biostatistics, clinical trial design, data analysis, data base
management, health promotion, behavior modification, nutrition, and
cardiovascular epidemiology.

Objectives and Scope

This study is envisioned as a nine-year effort to develop and test
intervention to reduce the rate of weight gain in schoolchildren of the
Native American community.  To provide a common understanding of
factors necessary for a collaborative effort, it is important for
applicants to understand at the outset certain common temporal goals
and features, e.g., study magnitude, phases, and handling of certain
central functions.  A number of possible components are listed purely
for illustrative purposes.  This is necessary so that the applicants
can address some similar fundamental topics in their applications.
When the recipients are convened, they can work together to develop the
common protocol, with the assistance of the two NHLBI Project
Scientists (an epidemiologist and a nutritionist).

The collaborative protocol will be developed by the Project Steering
Committee (see below) and will be subject to peer review by an
uninvolved expert group.  The study will move into its second (or
full-scale) phase only with the concurrence of both the award
recipients and the NHLBI.

The study consists of two phases.  Feasibility of the concept will be
determined during the first three years of the study.  If it is shown
to be feasible, the full-scale study will be implemented during the
next six years.  The planning and feasibility study is expected to be
completed over approximately a three-year period.  During this period,
investigators from the Field Centers, Coordinating Center, and the
NHLBI will collaboratively develop the study design, materials, forms,
protocol, and manual of operations to be cooperatively followed by all
Field Centers and Coordinating Center in the pilot test and subsequent
full-scale study if it is approved.  Some aspects of the protocol may
vary by center to meet local conditions and needs.  The expertise of
the investigators will be fully utilized to collaboratively determine
the most appropriate approach to prevent obesity among young Native
Americans.

The objective of Phase II---not within the scope of the current awards,
but relevant to the current RFA---will be to conduct a full-scale
randomized intervention trial to prevent the development of obesity.
It is envisioned that the intervention will be focused on
pre-adolescent elementary schoolchildren and that about 3000 Native
American students study-wide will participate in intervention and
control groups.  Schools are expected to be the unit of randomization.
An estimated six schools per center may be required in the full-scale
study.  The intervention is envisioned to last three to four years,
depending on the time needed to show measurable difference in the
selected obesity index between the intervention and control groups.
(Note that this is not weight loss but a reduction in the rate of
weight gain.)  Data analysis and publication of study results will
follow the completion of the intervention.

Timetable

The planning and feasibility study may be loosely divided into three
subphases covering about a three-year period.  There may be some
overlap of functions within each of the subphases and time estimates
are only approximations; the purpose of subphasing is to provide broad
guidelines of the work to be accomplished in Phase I and Phase II.

Phase I(a):     Planning and Protocol Development - 1 year

Phase I(b):     Training and Pilot-testing - 1 year and 6 months

Phase I(c):     Post-Pilot-testing Assessment - 6 months

The full-scale intervention study is expected to last six years and
might include the following subphases:

Phase II(a):    Intervention Preparation - 8 months

Phase II(b):    Intervention - 4 school years

Phase II(c):    Analysis and Reporting - 16 months

Objectives for Phase I

The planning and feasibility study will attempt to answer questions
related to political, intervention, and design issues.  Examples of
topics that need to be resolved and shown feasible include:

(1) How receptive are Tribal governments and community members to
various potential intervention strategies that may affect the school
curriculum, community programs, food distribution systems, and
traditional Native American attitudes and behaviors?

(2) What impact will the concerns of other relevant government
agencies, such as the Bureau of Indian Affairs (BIA), Centers for
Disease Control (CDC), Indian Health Service (IHS), United States
Department of Agriculture (USDA), and State and local boards of
education, have on the objectives of this initiative?

(3) Can a school curriculum focused on the prevention of obesity be
implemented in schools serving Native Americans?

(4) Can obesity prevention modifications in food service and food
distribution systems be implemented in Native American communities?

(5) Can a family-based component of the school curriculum be
implemented and accepted by Native American families?

(6) Can community programs be developed to support the prevention of
obesity among pre-adolescents in the Native American community?

(7) Can knowledge and attitudes related to obesity be changed in young
Native Americans with a focused intervention effort?

(8) Is a non-intervention arm acceptable as part of a controlled
randomized trial on the primary prevention of obesity in Native
Americans and, if not, what is an appropriate alternate intervention?

(9) What kinds of schools (BIA, tribally operated, public, or private)
are most appropriate as intervention sites?

(10) What measure of obesity should be used as the end point for this
study of obesity prevention in Native American elementary school
children?

Phase I(a)

Possible objectives of Phase I(a) are to develop a complete study
protocol, data forms, and a manual of operations, and to recruit and
prepare for the work with the schools.  The PI, through the Steering
Committee, will lead the planning effort.  Other key Center staff may
be involved in the planning.  The primary issues to be considered by
the Steering Committee during Phase I(a) include eligibility criteria,
recruitment of schools, selection of baseline/follow-up measurements,
and selection and design of the interventions.  Subcommittees of the
Steering Committee will likely be needed to address these issues.

Phase I(b)

The main activities of this phase are envisioned to include training of
intervention personnel, conducting the pilot test of the study protocol
which was developed in Phase I(a), and evaluating and cooperatively
revising the study materials and methods.  The Field Centers are likely
to be responsible for assisting school personnel and community
representatives in implementing the interventions, for collecting the
evaluation data, and for transmitting the data to the Coordinating
Center.

Phase I(c)

This Phase is expected to include refinement of the protocol,
intervention and measurement manuals, and study materials as well as
manuscript preparation.  Analyses of the data will be completed.  The
goal of these analyses will be to evaluate acceptance of and adherence
to interventions and the effects of the interventions.  Results of
these analyses will be used to address such questions as suggested
under "Objectives for Phase I," determine the feasibility of Phase II,
to plan Phase II, and as a basis for scientific papers and
presentations.

Phase II

Phase II(a) is expected to include recruitment of schools, final
production of protocol, manuals, materials, and forms, and training of
additional personnel.  Phase II(b) is envisioned to extend up to four
years to provide time to complete the intervention.  Support will be
continued for the Field Centers for about 10 months during Phase II(c)
to complete final entry of data, responses to edit queries, and 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.  The Coordinating Center
will support the paper writing efforts of Field Center and Coordinating
Center investigators with data analysis, statistical consultation,
editorial and clerical tasks, and coordination of meetings.

SPECIAL REQUIREMENTS

Additional Material to Include in the Application

To allow the development of a collaborative project among the award
recipients, it will be necessary for applicants to address, at a
minimum, a number of issues in the application.  Applicants for the
Coordinating Center should address design and biostatistical issues
related to a school-based obesity prevention project that may include
a family or home-based component and/or environmental components.
Points to consider are study endpoints, randomization methods, baseline
and outcome measures, contamination of study arms, sample size
requirements, and data analysis.

The Coordinating Center will serve as the central data management
facility for the study.  Data collected in the Field Centers will be
transmitted to the Coordinating Center for storage and analysis.
Coordinating Center applicants should discuss the mechanics of data
collection, the preferred mode of data transmission and editing, and
the requirements necessary for Field Centers to meet the data handling
and communication needs of the Coordinating Center.  Additionally,
Coordinating Center applicants should thoroughly discuss aspects of
quality control, which is the responsibility jointly of the Field
Center, Coordinating Center, and the NHLBI Project Scientists with the
Coordinating Center taking a primary role.

Study Organization

The Steering Committee will be the main governing body of the study
and, at a minimum, will be composed of the PIs of the Field Centers,
the PI of the Coordinating Center, and the NHLBI Project Scientists.
Unless otherwise explicitly provided, the non-NHLBI investigators will
have the lead role in the Steering Committee.  Each Center and the
NHLBI will have one vote.  The Committee may meet as often as eight to
ten times in the first 12 months of the study and three to four times
a year thereafter.  All major scientific decisions will be determined
by majority vote of the Steering Committee.  A chairperson (whom will
be other than an NHLBI staff member) shall be selected by the end of
the second meeting of the Steering Committee.  The first two meetings
of the Steering Committee will be convened by the NHLBI Project
Scientists.  The Steering Committee will have primary responsibility
for the development of the study protocol, facilitating the conduct of
the study, and reporting of the study results.  Subcommittees of the
Steering Committee will be established as necessary.  The NHLBI may
have one representative, as appropriate, on each subcommittee.

With data submitted centrally, the protocol will define rules regarding
access to data and publications.  A Data and Safety Monitoring Board,
to be appointed by the NHLBI, will review progress at least annually
and report to the NHLBI.

Terms and Conditions of Award

The administrative and funding mechanism to be used to undertake this
project will be cooperative agreements, an assistance mechanism.  Under
the cooperative agreement, the NIH assists, supports and/or stimulates
and is involved substantially with recipients in conducting a study by
facilitating performance of the effort in a "partner" role.  Consistent
with this concept, the tasks and activities in carrying out the studies
will be shared among the awardees and the Institute Project Scientists.
The tasks or activities in which awardees will have substantial
responsibilities include protocol development, participant recruitment
and follow-up, data collection, quality control, interim data and
safety monitoring, final data analysis and interpretation, preparation
of publications, collaboration with other awardees, and collaboration
with the NHLBI Project Scientists.  The NHLBI Project Scientists will
have substantial responsibilities in protocol development, quality
control, interim data and safety monitoring, final data analysis and
interpretation, preparation of publications, collaboration with
awardees, and coordination and performance monitoring.  It is
anticipated that awardees will have lead responsibilities in study
design, protocol development, final data analysis and interpretation,
and in the preparation of most publications.  It is anticipated that
the NHLBI Project Scientists will have lead role responsibilities in
quality control and interim data and safety monitoring, and in the
preparation of some publications.  The NHLBI Project Scientists will
have membership on the Steering Committee and, as appropriate, its
subcommittees.

Awards resulting in response to this RFA are for three years only.  It
is anticipated that Phase II will be undertaken if Phase I is completed
successfully.  Progression to Phase II will be undertaken only after
external review and recommendation by the NHLBI as noted earlier, at
the end of the three-year planning and feasibility study, two possible
options will be available to awardees:  (1) the NHLBI hopes to invite
competitive renewals under the Cooperative Agreement mechanism for the
six-year full-scale study, if feasibility is shown, or (2) the awardees
may submit grant applications through the usual investigator-initiated
grants program.

Awardees will retain custody of and have primary rights to their data
developed under these awards, subject to Government, e.g., NHLBI, NIH,
or PHS, rights of access consistent with current HHS, PHS, and NIH
policies.

Any disagreement that may arise in scientific matters 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 the 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.

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 grants administration policy statements.

The NHLBI reserves the right to terminate or curtail the study (or an
individual award) in the event of a substantial shortfall in (a)
participant recruitment, follow-up, data reporting, quality control, or
other major breech of the protocol, or (b) substantive changes in the
agreed-upon protocol to which the NHLBI does not agree, or (c) reaching
a major study endpoint substantially before schedule with persuasive
statistical significance, or (d) human subject ethical issues that may
dictate a premature termination.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of disease, disorder or condition
under study; special emphasis must be placed on the need for inclusion
of minorities and women in studies of diseases, disorders and
conditions which disproportionally affect them.  Because this RFA is
directed to a single minority population, it is not restricted by the
minority section of this policy statement.  This policy is intended to
apply to males and females of all ages.  If women are excluded or
inadequately represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided.

The composition of the proposed study population must be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.  This information must be included
in the form PHS 398 in Sections 1-4 of the Research Plan and Summarized
in Section 5, Human Subjects.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are not subject to these
policies.  However, every effort should be made to include human
tissues from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be addressed by
applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women in a study design is inadequate to answer the scientific
question(s) addressed AND the justification for the selected study
population is inadequate, it will be considered a scientific weakness
or deficiency in the study design and will be reflected in assigning
the priority score to the application.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 15, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the PI, 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 subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows the NHLBI staff to estimate the potential review workload and
to avoid conflict of interest in the review.

The letter of intent is to be sent to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7363
FAX:  (301) 402-1660

APPLICATION PROCEDURES

Applicants applying for both a Field and Coordinating Center must
submit separate applications.

A detailed budget page should be submitted for each of the three
12-month budgets periods.  Costs relating to subphases I(a), I(b), and
I(c) should be clearly designated on each budget page.

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these awards.  These forms are available at most
institutional business offices, from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441,
and from the NIH Project Scientists named below.

The RFA label available in the PHS 398 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 2a of the face page of
the application form and the YES box must be marked.

Send or deliver the original signed application and three legible
complete photocopies of it to:

Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**

Send two additional copies of the application to:

C. James Scheirer, Ph.D.
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7363

IT IS IMPORTANT TO SEND THESE TWO COPIES AT THE SAME TIME AS THE
ORIGINAL AND THREE 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.

Application must be received by December 18, 1992.  An application not
received by this date will be considered ineligible.

REVIEW CONSIDERATIONS

General Considerations

All applicants will be judged on the basis of the scientific merit of
their proposed study and their documented ability to conduct the
essential study components as broadly outlined in the RESEARCH
OBJECTIVES of this RFA.

Review Method

Upon receipt, applications will be reviewed by the NHLBI staff for
their completeness and for their responsiveness to this RFA.
Incomplete applications will be returned to the applicants without
further consideration.  If an application is unresponsive, the
applicant will be contacted and given an opportunity to withdraw the
application or to have it considered for the regular,
investigator-initiated grant program of the NIH.  If an application
submitted in response to this RFA is identical to or substantially the
same as one already submitted to the NIH for review by the NHLBI
Council in the same cycle, the PI will be asked to withdraw the pending
application before the new one is accepted.  Simultaneous submission of
identical applications will not be allowed.

Applications judged to be responsive will be reviewed for scientific
and technical merit by an initial peer review group, that will be
convened by the Division of Extramural Affairs, NHLBI, solely to review
these applications.  The initial review will include a preliminary
evaluation to determine scientific merit relative to the other
applications received in response to this RFA (triage); the NIH will
remove from further consideration applications judged to be
noncompetitive and promptly notify the PI and the official signing for
the applicant organization.  Those applications judged to be
competitive will be further evaluated for scientific/technical merit by
the usual peer review procedures, including, if deemed appropriate, an
applicant interview in or near Bethesda (a reverse site visit) at the
applicant's expense.  Subsequently, they will be reviewed by the
National Heart, Lung, and Blood Advisory Council.

Review Criteria

Applicants are encouraged to submit and describe their own ideas on how
best to meet the goals of the study, but they are expected to address
issues identified under SPECIAL REQUIREMENTS of this RFA.  Applications
will be judged primarily on the scientific quality of the application,
the discussion of considerations relevant to this RFA, expertise of the
investigators, their capability to perform the work proposed, and a
demonstrated willingness to work together with other Centers and the
NHLBI Project Scientists.

The review group will assess:

1.  Scientific merit of the study, including:

o  analytic, biostatistical, and design features of the study including
familiarity with nutrition and intervention issues; and

o  rationale for the measurement strategies and data analysis.

2.  Organizational and administrative ability to serve as a
coordinating center for a multicenter randomized controlled
intervention trial including;

o  plans to develop protocols including forms development and related
training materials and the study Manual of Operations;

o  plans to process, manage, and ensure the quality of data;

o  plans to oversee study progress and adherence to protocol; and

o  plans to develop multicenter communication system for transfer of
data and documents among the Field Centers, the Coordinating Center,
and the NHLBI.

3.  Qualifications, experience, and commitment of key personnel
including:

o  scientific and administrative abilities of the PI and
coinvestigators;

o  experience of the investigators and other key personnel in
biostatistics and database management and research related to
school-based intervention;

o  plans for key personnel to devote adequate time for the effective
conduct of the study; and

o  willingness to work collaboratively with other Centers and the
NHLBI.

4.  Facilities and equipment to function as a Coordinating Center for
a multicenter intervention trial.

5.  Appropriateness of the budget for the work proposed.

AWARD CRITERIA

Applications recommended by the NHLBI Advisory Council will be
considered for award based upon (a) scientific and technical merit and
the requirements explicitly stated in this RFA; (b) program balance,
including, in this instance, sufficient compatibility of features to
make a successful collaborative program a reasonable likelihood; and
(c) availability of funds.

Timetable

Letter of Intent:                                            October
15, 1992
Application Receipt Date:                                    December
18, 1992
Review by National Heart, Lung, and Blood Advisory Council:  May 1993
Anticipated Award Date:                                      July 1,
1993

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Inquiries may be directed to the Project Scientist:

Richard R. Fabsitz
Clinical and Genetic Epidemiology Branch
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Federal Building, Room 3A17
7750 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-4333

or to the Deputy Project Scientist:

Marguerite A. Evans
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, MD  20892
Telephone:  (301) 496-3503

Fiscal and administrative matters to:

Marie Willett
Deputy Chief, Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A12
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7255

AUTHORITY AND REGULATIONS

This project is described in the Catalog of Federal Domestic Assistance
No. 93.837.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR 74.  This project
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.

APPENDIX

Scientific Background

Prevalence of obesity in Native Americans:  Because Native Americans
are not represented in most national health and nutrition surveys, data
on the prevalence of overweight among Native Americans are limited to
smaller studies that are based on limited population surveys of
specific tribes.  However, they all indicate a greater proportion of
overweight adults among American Indians compared to U.S. adults
(Donato, Evans, Haines 1990).

Broussard and colleagues (1991) used several different data sources to
estimate the prevalence of overweight and obesity in Native Americans.
The prevalence of overweight and obesity were assessed by using body
mass index (BMI, in kg/m(2)).  For adults the prevalence of overweight
is defined as the percentage of adults with BMI >85th percentile of the
NHANES II reference for men and women aged 20 to 29 years:  BMI >27.8
for men and >27.3 for women.  The prevalence of obesity is defined as
the percentage of adults with BMI >95th percentile:  BMI >31.1 for men
and >32.3 for women.  The estimated prevalence of overweight in Native
American males >18 years was 33.7 percent (obesity 13.7 percent)
compared with the U.S. rate of overweight of 24.1 percent (obesity 9.1
percent) for males and in Native American females >18 years 40.3
percent (obesity 16.5 percent), which is much greater than the U.S.
rate of 25.0 percent (obesity 8.2 percent) for females.  Data from the
Strong Heart Study suggest that there is variability in obesity within
the Indian population.

There is evidence that the prevalence of obesity is high among Native
Americans in various geographic areas for both men and women across all
ages.  Very early data from the three geographic areas of the Strong
Heart Study, an area near Phoenix, Arizona, the southwestern area of
Oklahoma, and the Aberdeen area of North and South Dakota, showed the
mean BMI's in each respective area to be 33.6, 31.2, and 30.3 for women
aged 45-74 years and 30.6, 30.6, and 28.8 for men aged 45-74 years
(unpublished).  Seventy percent of female Cree and Ojibwa Indians in
northwestern Ontario between the ages of 35 and 64 had BMI's >25
(McIntyre and Shah 1986).  In comparison, 87 percent of female Pima
Indians aged 35 to 44 years had BMI's >27.3 decreasing to 74 percent in
females aged 55 to 64 years (Knowler et al. 1991), suggesting that the
problem may actually be increasing in younger Indians.

Of greater concern, overweight and obesity rates in American Indian
adolescents and preschool children are higher than the respective rates
for U.S. all-races combined (Broussard et al. 1991).  Most striking are
the adolescents from Arizona (44.1 percent of boys and 51.8 percents of
girls aged 14-17 are obese---74.6 and 78.3 percent respectively are
overweight).  For adolescents, overweight is defined as BMI >23.0 for
males aged 12 through 14, and 24.3 for males aged 15 through 17; 23.4
for females aged 12 through 14, and 24.8 for females aged 15 through
17.  Preliminary data (unpublished) from the CDC-IHS height/weight
school survey (1991) for three locations, Phoenix, Billings and Navajo,
show the mean BMI's for boys aged five are 16.4, 16.5 and 16.5
respectively, aged 12: 23.2, 21.6 and 19.6, and aged 17 mean BMI's are
25.2, 26.0 and 22.4 respectively.  For girls aged five the mean BMI's
are 16.2, 16.3 and 15.7 respectively, aged 12: 23.1, 21.5 and 21.0, and
for aged 17 26.5, 23.9, and 24.5.

At even younger ages the prevalence of obesity is also excessive.  The
prevalence rate of obesity in Native American children aged zero to
four participating in public health programs was 11.2 percent, higher
than the U.S. all-races rate of 8.1 percent (Broussard et al. 1991).
Freedman et al. (1992) found that about 12 percent of American Indian
preschool children were above the 95th percentile of weight-for-height,
and American Indian preschool children had the highest mean
age-adjusted Quetelet index compared to white, black, and Hispanic
preschoolers.

The data suggest that there has been a secular change in height,
weight, overweight, and obesity among American Indian children and
adolescents (Broussard et al. 1991).  Over the past 35 years (Sugarman,
White, Gilbert 1990) obesity has increased in Navajo schoolchildren;
compared with data from 1955, mean weights increased 28.8 percent among
boys and 18.7 percent among girls across all age groups.  Similarly,
there have been modest increases in age- and sex-specific mean BMI's of
Pima Indians for the past 25 years (Knowler et al. 1991).

Relationship of obesity to health outcomes:  Many of the health
problems of American Indians and Alaska Natives are related to obesity.
Along with the increased prevalence of obesity, there has been an
increase in cardiovascular disease.  There has also been an epidemic of
diabetes and an increase of other chronic diseases, including end-stage
renal disease, gallbladder disease, uterine cancer, and perinatal
mortality rates.  Their precise magnitude is poorly defined (Broussard
et al. 1991).  Health implications of obesity vary greatly in the
Indian Health Service areas.  This variability reflects the
co-existence of other risk factors, including smoking, hypertension,
diabetes, and hypercholesterolemia, as well as differences in genetic
predisposition for various diseases (Welty 1991; Young, Sevenhuysen
1989).  Although Native Americans are not a homogeneous group with
regard to health problems, they have all suffered adverse effects from
the high prevalence of obesity.

The degree to which obesity in childhood imposes a risk for obesity in
adulthood is of great concern.  Data from the Muscatine Study indicates
that obesity acquired in adolescence has deleterious effects on adult
cholesterol levels and lipoprotein fractions (Lauer et al. 1988).  In
addition, children who gain in ponderosity show a gain in their blood
pressures which does not depend on the initial blood pressure (Clarke
et al. 1986).  Data from the Bogalusa Health Study indicate that
children who are obese over consecutive examinations are likely to
become obese adults (Freedman 1987).  This is likely to occur in Native
American children; however, these patterns have not yet been
documented.  Johnston (1985) has concluded that the relative risk for
obese children becoming obese adults, compared with the risk for
non-obese children, may be as high as 2.3 and this increases markedly
with age.  By pre-adolescence the relative risk is >6.

Potential contributors:  The causes of obesity are complex and include
cultural, familial, and genetic factors.  Studies of energy expenditure
among the Pima Indians suggest that a low metabolic rate contributes to
the familial aggregation of obesity in man (Bogardus, Lillioja,
Ravussin 1990).  In addition, there may be multiple metabolic
differences between Indians and non-Indians that may predispose Native
Americans to become obese when food is abundant.  Neel's thrifty-gene
hypothesis in 1962 suggested that obesity results from the introduction
of a continuous and ample food supply to people who have evolved an
ability to store energy efficiently, permitting survival through
millennia of feast-famine cycles (Neel 1962).  Since obesity may have
multiple possible determinants, it is unclear whether the primary
defect is genetic, environmental, or an interaction between the two
(Howard et al. 1991).

Sociodemographic and lifestyle determinants of obesity identified in
some Native American groups are compatible with findings from surveys
in other populations.  Age, sex, marital status, smoking, alcohol use,
employment, income, and education were significant predictors of BMI.
The observations that there is more obesity/overweight in younger
Native Americans suggest that the older adults have had less exposure
to factors leading to obesity than have the younger adults (Knowler
1991).  Also, not all tribes share the general American cultural ideal
for slimness.  Some believe that being somewhat heavy is advantageous
and a sign that one is not suffering from a disease or subject to
sorcery (Jackson, Broussard 1987; Joos 1980).  On the other hand, the
mainstream social ideals of thinness appear to have been internalized
by Native American youths (The State of Native American Youth Health
1992); for example, about 44 percent of female adolescents worry a
great deal about being overweight and about 28 percent are very
dissatisfied with their weight.  Stress due to acculturation may also
influence eating behavior in Native Americans (Pine 1984, 1985).

Racial differences among young non-Indians are currently being
investigated in the NHLBI's National Growth and Health Study.  Over
five years, this study will estimate the occurrence of obesity among
black and white girls age nine to ten at baseline and assess the
predictors of transition to the obese state, the correlates of this
transition, and the relationship of this transition to other CHD risk
factors.  Baseline data revealed that black girls had higher BMI and
greater skinfolds than white girls.  They also reported consuming more
calories and more grams of fat and watching considerably more
television than white girls.  Results from the psychosocial
questionnaires showed that compared to white girls, black girls were
more content with their present weight, more satisfied with their
appearance, and more satisfied with their separate body parts.

Although the exact mechanisms leading to obesity are unclear, the fact
remains that for an individual to add fat to body stores requires
taking in more energy than is expended.  The increasing rate of obesity
may be related to fairly recent changes in lifestyle among many Native
American tribes (Jackson 1986; Jackson, Broussard 1987).  As late as
1967 malnutrition was a serious health problem in a small Navajo
community (Welty 1991).  However, in the late 1960s feeding programs,
which included commodity foods high in fat and calories, were made
available to reach malnourished people.  A variety of Federal food
assistance programs are currently available.  Not all programs are
operating at each community, and no programs are operating in some
communities.  In addition to Federal assistance, many non-Federal
organizations provide food to Native Americans (GAO 1989).  However,
the Family Food Distribution Program, USDA, and the Food Stamp Program
contribute significantly to Native American diets.  Food may also be
purchased with vouchers distributed through the Special Supplemental
Food Program for Women, Infants, and Children (WIC) program.
Participation in particular programs varies with the economic
restrictions and frequently involves periodic switching to meet family
needs (USDA 1990).  In the Pimas, 33 percent of the women participate
in the commodity food distribution program, 13 percent in the Food
Stamp Program, and 39 percent in the WIC program (Smith et al.
unpublished).  Commodity foods contributed 40 to 50 percent of the
intake of most nutrients in Navajo diets surveyed.  Hunting, gathering,
and on-reservation farming contribute less to the total energy intake
than commodity distribution programs, foods purchased on or off
reservation, and/or restaurants.  For example, 16 percent of Pima
Indians indicated the use of desert animals or fish for food (Smith et
al. unpublished).

Native diets have changed from high fiber and low fat to diets high in
refined and simple carbohydrates and fat, and low in fiber (Jackson,
Broussard 1987).  There is limited published research regarding food
patterns of Native Americans; however, a number of investigators
(Teufel et al. 1990; Simons-Morton et al. 1990; Owen et al. 1981; Toma
and Curry 1980; Koehler et al. 1989; Smith et al. 1991) have identified
dietary practices which may contribute to obesity including the wide
use of butter, lard, whole milk, fry breads, and fried meats and
vegetables, as well as the generous use of fats in the preparation of
beans.  Sweets and snacks, including alcoholic and non-alcoholic
beverages, account for high caloric intakes in some groups.  The diet
of Alaska Native adults is higher in energy and fat than the general
U.S. adult population with the major contributors of fat being fish,
agutuk, beef, seal oil, whale blubber, chicken, butter, and margarine
(Nobmann et al. 1992).  At the same time, physical activity markedly
decreased.  Most Native American populations developed obesity in less
than a generation.  So it can be said that the cause of obesity in
Native Americans is related to the relative abundance of high-fat foods
accompanied by rapid changes from an active to a sedentary lifestyle.

Obesity intervention programs:  The diversity of the population, in
addition to cultural and social differences, provide challenges for
effective health programming.  Many health professionals and
researchers have advocated culturally sensitive and population- or
community-based approaches to nutrition and cardiovascular health
education with increased involvement by Native Americans to achieve a
significant impact.  Intervention trials are needed urgently in Native
American communities to develop and test effective education, diet, and
exercise strategies for weight reduction in overweight individuals, but
the history of such efforts in the general population suggests that
obesity prevention may have a greater impact.  Because of the concern
regarding the consequences later in life of overweight among Native
American youths, effective intervention programs to encourage increased
physical activity and healthful eating habits need to be developed.

Weight-reduction programs in obese adults have been conducted and are
ongoing, but the literature documents only a few Native American
population-based programs specific to obesity.  The Zuni Diabetes
Project is a community-based exercise and weight-control program
initiated in July 1983 to reduce rates of obesity and provide primary
and secondary prevention of non-insulin-dependent diabetes mellitus
(NIDDM).  Two studies of the project's activities demonstrated that (1)
participation in a community-based exercise program can produce
significant weight loss and improvement in glycemic control in obese
adult Zuni Indians with NIDDM, and (2) weight-loss competitions appear
to be an important public health model for health-behavior change in
communities similar to that of Zuni, New Mexico (Heath et al. 1991).
Other projects (personal communications) for primary and secondary
prevention of obesity in various stages of development and
implementation include a point-of-purchase education program in a
grocery chain and a school-based program targeting normal and
overweight adolescents on the Navajo Reservation.

A number of school-based weight control programs for obese children
have met with successful results (Brownell, Kaye 1982; Epstein, Masek,
Marshall 1978; Seltzer, Mayer 1970; Wolf, Cohen and Rosenfeld 1985).
Their results indicate that an effective program consisting of
increased physical activity, dietary education, and psychological
support can be introduced in a school system.  Much of the success is
dependent on the degree of cooperation of the community, the school
board, the staff of the school system and available facilities.  These
studies also indicate that the lower grade levels at which the weight
control program is instituted, the better for the obese, and they must
be continuously available for the students throughout their academic
careers.  D'Arca et al. (1986) proved the efficacy of an obesity
prevention program in elementary and nursery schoolchildren.

Obesity is a family matter whether it afflicts children or adult
members. The family as a culture transmitter plays a role in the
development of health maintenance practices and plays a pivotal role in
the creation and control of obesity among both children and adults.
Epstein et al. (1981) noted that similarities between parent and child
behavior during treatment for obesity, but not the follow-up period
suggest that different mechanisms are at work during acquisition and
maintenance of eating and exercise for the parents and children.
Whereas a parent may lose self-control and act as an inappropriate
model, child behavior can be maintained by consistent parental support
or child self regulation.  Epstein et al. (1990) and Stunkard and
Berkowitz (1990) state that treatment of obesity in childhood can
produce effects that persist into young adulthood, especially if
behavioral, family-based treatment is initiated when the child is
between the ages of 6 and 12 years (Epstein et al. 1990).

More general school curricula have been adopted in a number of Native
American communities in the last few years that incorporate a component
of obesity control in the context of overall health.  Various schools
serving the Oglala Sioux in South Dakota and the Pima in Arizona have
modified the Growing Healthy curriculum produced by the National Center
for Health Education to improve the health of their school-age
population.  In New Mexico the Navajo people have received instruction
in weight control as part of a program to prevent the development of
diabetes.  While each of these includes obesity control in the message,
none provides a focus on obesity prevention.

Related NHLBI Studies:  The NHLBI is sponsoring a five-year project,
the Southwestern Cardiovascular Curriculum Project, in predominantly
Pueblo and Navaho elementary schools.  This project is testing a
cardiovascular curriculum developed from existing curricula during a
feasibility study. The revised obesity unit changes the focus from
obesity to nutrition.  In addition to the curriculum content, the
project employs outreach activities including family participation and
involvement, community health days, and peer and inter-generational
involvement and modeling.  These supplemental activities are designed
to reinforce the curriculum, to encourage diffusion of the project
materials to families and community, and to maintain cultural relevance
of the project.  Preliminary results from the first two years show a
change in knowledge and practices.  For example, the intervention
schools show a greater increase in knowledge of cardiovascular biology
and disease risk factors and an increase in physical activity (self
report) compared to the controls.  The intervention schools also show
a decrease in the percent using butter at the table.

Another NHLBI-sponsored study directed to Native Americans is the
Strong Heart Study which is a longitudinal observational study of
cardiovascular disease in American Indian men and women ages 45-74 (Lee
et al. 1990).  It is designed to estimate CVD mortality and morbidity
rates and the prevalence of known and suspected CVD risk factors in
American Indians.  The study population consists of 12 tribes in three
geographic areas: an area near Phoenix, Arizona, the southwestern area
of Oklahoma, and the Aberdeen area of North and South Dakota.

The envisioned study design described in this RFA is similar to the
NHLBI-sponsored study, Child and Adolescent Trial for Cardiovascular
Health (CATCH) (Perry et al. 1990).  CATCH is a multisite intervention
targeting third-fifth grade students and focuses on multiple
cardiovascular health behaviors.  The study has three phases:  Phase I
deals with study design, intervention, and measurement development,
Phase II involves the main trial in 96 schools in four states, and
Phase III focuses on analysis.

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