BEHAVIORAL STRATEGIES IN CHILDREN AND ADOLESCENTS TO PREVENT OSTEOPOROSIS LATER
IN LIFE

Release Date:  April 28, 1998

RFA:  HD-98-008

P.T.

National Institute of Child Health and Human Development

Application Receipt Date:  August 25, 1998

PURPOSE

The National Institute of Child Health and Human Development (NICHD) invites
studies of behavioral strategies to prevent osteoporosis.  The purpose of this
RFA is to develop behavioral methods to prevent osteoporosis by physical activity
and dietary means in childhood.

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 Request for Applications (RFA),
Behavioral Strategies in Children and Adolescents to Prevent Osteoporosis Later
in Life, is related to the priority areas of nutrition and chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report: Stock No.
017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
units of State and local governments, and eligible agencies of the Federal
government.  Individuals from all racial/ethnic groups, persons with
disabilities, and women are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

The mechanism available for support of applications in response to this RFA will
be through the National Institutes of  Health (NIH) Research Project Grant (R01)
program.  Policies that govern the grants award programs of the PHS will prevail. 
The support of grants pursuant to the RFA is contingent upon receipt of
appropriated funds for this purpose.

This RFA is a one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications.  However,
if the NICHD determines that there is a sufficient continuing program need, the
Institute may announce a request for competitive continuation applications.  The
total project period for an application submitted in response to this RFA may not
exceed five years.  The earliest anticipated award date is April 1, 1999.

FUNDS AVAILABLE

It is anticipated that six to eight new grants will be awarded under this
program, contingent upon receipt of a sufficient number of meritorious
applications and the availability of funds.  The NICHD has set aside $2.5 million
for total costs in the first year.

RESEARCH OBJECTIVES

Background

Osteoporosis afflicts an estimated 25 million Americans and generates annual
medical costs of about $13.8 billion.  Osteoporotic fractures result in
substantial morbidity and mortality, but a significant portion of the economic
and human costs may be averted through efforts at prevention.  Reduced peak bone
mass is a major determinant of fracture risk in later life.  Although genetic
factors control most of skeletal development, it has been estimated that up to
25% of bone mass is regulated by behavioral factors such as nutrition and
exercise.  Since all of the peak bone mass is accumulated during the first two
decades of life, this is an extremely important developmental period in which to
encourage dietary and other behavioral practices that optimize skeletal health.

Although it is known that calcium and other nutrients in dairy products
contribute to the development of a healthy skeleton, results of the USDA
Household Survey and the NHANES III indicate that the average adolescent girl
consumes only about 800 mg of calcium per day, which is 500 mg less than the
current Dietary Reference Intake (DRI) and 700 mg less than the amount
recommended by the NIH Consensus Conference on Optimal Calcium Intake in June
1994.  Moreover, a comparison between NHANES II (1976-80) and NHANES III (1988-
91) indicates a decline of about 100 milligrams in mean daily calcium intake in
male and female children 6-to-11 years old.  This dietary calcium deficiency
reflects a deleterious pattern of food choices and eating behavior during
childhood and adolescence.

Results of the Teen Lifestyle Project showed that two-thirds of adolescent girls
are dieting and that 90% of white girls are dissatisfied with their body image. 
Their concerns about body weight lead them to substitute low-calorie drinks for
dairy products in their diet.  When carried to extremes, dieting among adolescent
girls can lead to anorexia, amenorrhea, and osteopenia, a triad seen in high
performance athletes and ballet dancers.  Although osteoporosis is more common
in women, about one-fifth of osteoporotic fractures occur in men; and,
occasionally, men suffer from severe osteoporosis in middle age.  Therefore,
behavioral studies of the prevention of osteoporosis should not be limited to
females.

Studies of calcium supplementation have indicated that a significant increase in
bone mineral density can be demonstrated in children and adolescents given
supplemental calcium.  However, follow-up studies have shown that these calcium-
induced gains in bone density are not sustained following cessation of calcium
supplementation.  These findings imply a need either for ongoing calcium
supplementation or for a dietary intake of calcium that closely approximates the
DRI of 1300 mg during adolescence.  The prevailing high-sodium diet in the United
States also implies that a perennially high calcium intake is necessary to
maintain any increase in bone density attained during childhood and adolescence
from either high calcium diets or by dietary supplementation with calcium.

Research Scope

The objective of this RFA is to encourage and promote innovative behavioral
strategies during childhood and adolescence to prevent the development of
osteopenia and osteoporosis.  Of particular interest in studying the application
of behavioral intervention strategies to the prevention of osteopenia and
osteoporosis is to identify specific behavioral contingencies and reinforcement
regimens that are optimal at specific developmental stages.  In addressing the
issue of prevention, an important question is which behavioral interventions are
most influential in which individuals at which stages of development during
childhood and adolescence.

There is also a need to contrast different approaches to the problem of how to
induce and maintain behavioral change.  The efficacy of various theoretically
driven models should be compared to each other and to control situations.

Studies of changes in behavior are encouraged as opposed to studies that document
increases in knowledge of diet and exercise.  Such studies require a longitudinal
perspective, and evidence will be needed of behavioral changes in the form of
direct observations, food frequency diaries, and monitored activity, as well as
changes in physical outcome variables such as bone mineral density, body
composition, and aerobic capacity.  Multiple measurement points will be needed
to ascertain maintenance and decay of behavioral changes.  A variety of
statistical methods are available for analysis of longitudinal data, such as
repeated measures analysis.  State-of-the-art statistical methods should be
employed in the analysis of longitudinally acquired data.

Although behavioral interventions have been shown to be effective in modifying
many different types of behaviors in the social, cognitive, and emotional
domains, a major concern is that initial behavioral change may neither persist
nor generalize to settings that are different from those in which the
interventions were applied.  Therefore, studies that focus on identifying
critical programmatic features that increase the probability of long-term
preventive effects and generalization are encouraged.  In this regard, it will
also be important to identify the psychosocial characteristics of children and
adolescents that predispose toward success or failure in maintaining long-term
behavioral change.

The following are examples of research topics that are appropriate for this RFA;
however, they are not to be considered as exclusive or limiting:

o  Behavioral studies focused on encouraging greater calcium and lesser dietary
sodium intake in children and adolescents; education and motivational research,
especially behavioral studies that encourage exercise and discourage sedentary
behavior as strategies to strengthen bones during childhood and adolescence.

o  Studies that test the efficacy of interventions designed to reduce the risk
of osteoporosis by targeting families, schools, communities, industry, the media,
or other institutions.

o  Identifying children at high risk of developing osteoporosis later in life and
designing appropriate behavioral intervention for such vulnerable children. 
Behavioral intervention studies designed to alter calcium, sodium, and vitamin
intake are encouraged that target children and adolescents found to be at high
risk for osteoporosis later in life.

o  Behavioral intervention studies to improve patterns of physical activity in
children and adolescents who are found to be at increased risk.

o  Studies designed to develop and validate robust outcome measures to assess the
efficacy of behavioral interventions in children and adolescents.

o  Studies of the effects of behavioral intervention strategies in populations
of children and adolescents who are at high risk of osteopenia in adolescence and
of osteoporosis later in life.  Such vulnerable individuals may include, but are
not limited to:  (1) adolescent dancers, gymnasts and runners with the female
athletic triad; (2) adolescent girls with primary or secondary amenorrhea or
oligomenorrhea; (3) children and adolescents who diet excessively or who are
overly concerned about their weight or body image; (4) children and adolescents
in the lowest quartile of daily calcium intake; and (5) children and adolescents
who are excessively sedentary, especially adolescent females.  Behavioral
modification in such vulnerable populations should be designed to reverse the
deleterious attitudes and behaviors that increase the risk of osteopenia and
osteoporosis.  The development and use of robust outcome measures in assessing
the success of behavioral modification are encouraged.

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 are 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 have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513), and the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,
1994, Volume 23, Number 11.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used in applying
for these grants.  Application kits are available at most institutional offices
of sponsored research and may be obtained 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:
asknih@od.nih.gov.

The RFA label available in the application form PHS 398 (rev. 5/95) 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
(BEHAVIORAL STRATEGIES IN CHILDREN AND ADOLESCENTS TO PREVENT OSTEOPOROSIS LATER
IN LIFE) and number (HD-98-008) must be typed on line 2 of the face page of the
application and the YES box must be checked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 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 also be
sent to:

Scott Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01 - MSC 7510
Bethesda, MD  20892-7510

Applications prepared in response to this RFA must be received by August 25,
1998.  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
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 must applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NICHD.  Incomplete 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 NICHD in accordance
with the review criteria stated below.

As part of the initial merit review, a process may be used by the initial review
group in which applications will be determined to be competitive or non-
competitive based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be competitive will be
discussed in depth and assigned a priority score.  Applications determined to be
non-competitive will be withdrawn from further consideration.  A summary
statement will be prepared, and the principal investigator and the official
signing for the applicant organization will be notified.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written review, comments on the following aspects of the application will be made
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in the assignment of the overall score.

The review criteria for the evaluation of applications are the following:

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?

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?

Innovation: Does the project employ novel concepts, approaches or methods?  Are
the aims original and innovative?  Does the project challenge existing paradigms
or develop new methodologies or technologies?

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 (if any)?

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 initial review group will also examine: the adequacy of plans to include both
genders and minorities and their subgroups as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

AWARD CRITERIA

Scientific merit and technical proficiency, as determined by peer review, based
on the demonstrated and projected capabilities described in the application, will
be the predominant criteria for determining funding priorities.

Schedule

Application Receipt Date:    August 25, 1998
Review by Advisory Council:  January 1999
Anticipated Date of Award:   April 1, 1999

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is
welcomed.

Direct inquiries regarding programmatic issues to:

Gilman D. Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11 - MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5593
FAX:  (301) 480-9791
Email:  GRAVEG@EXCHANGE.NIH.GOV

Direct inquiries regarding fiscal matters to:

E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17 - MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email: SHAWVERD@EXCHANGE.NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.865, Research for Mothers and Children and Catalog of Federal Domestic
Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Research.  Awards are
made under the authority 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 Part 52 and
45 CFR Part 74.  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 and contract 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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