DECREASING WEIGHT GAIN IN AFRICAN-AMERICAN PREADOLESCENT GIRLS - FIELD AND
COORDINATING CENTERS

Release Date:  April 17, 1998

RFA:  HL-98-010

P.T.

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  May 18, 1998
Application Receipt Date:  July 30, 1998

PURPOSE

The Division of Epidemiology and Clinical Applications (DECA) invites
cooperative agreement applications for an estimated four Field Centers and one
Coordinating Center to participate, with the assistance of the National Heart,
Lung, and Blood Institute (NHLBI), in a collaborative multicenter project on
decreasing weight gain during adolescence in high-risk African-American
preadolescent girls.

The proposed 3-phase research project is designed to address the problem of
increasing obesity in the United States, a major cardiovascular disease risk
factor that is not showing secular improvement.  Although numerous public
health organizations strongly recommend that obesity be prevented, few
interventions have been tested to implement these recommendations.  Because
the higher prevalence of obesity in African-American women has been
hypothesized to account, in part, for excess cardiovascular disease morbidity
and mortality in this population group, this research project will be directed
at high-risk African-American girls.

The purpose is to develop and test interventions to prevent obesity by
decreasing weight gain during the high-risk transitional period from pre-
puberty to puberty in African-American girls who are at high risk for
developing obesity.  Phase 1 will provide support over 2-3 years for the
development of interventions through needs assessment and formative research
and the pilot-testing of the interventions and the measurement instruments. 
Phase 2 will support single-center randomized controlled trials for a period
of 4-5 years to test the efficacy of the interventions developed in Phase 1. 
Phases 1 and 2 will total no more than 7 years for the Field Centers and 8
years for the Coordinating Center and be funded by the same mechanism.  A
Protocol Review Committee will review the results of Phase 1 and the Phase 2
protocols before Phase 2 recruitment begins.  About four Field Centers will be
supported; two targeting African-American girls with low socioeconomic status
(SES) and two targeting African-American girls with higher SES.  Although the
interventions developed by each Field Center will be unique, the centers will
collaborate to define and standardize participant eligibility criteria and key
measurements across all centers.  A Coordinating Center will be funded to
support the standardization and to analyze results of Phase 2.  A Phase 3 for
dissemination research may be initiated after review of Phase 2 results; open
competition for new awards would be conducted for Phase 3.  This Request for
Applications (RFA) is for Phases 1 and 2 only.

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, Decreasing Weight Gain During
Adolescence in African-American Girls, is related to the priority areas of 
nutrition, physical activity and fitness, educational and community-based
programs, heart disease and stroke, and diabetes.  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

Among the disciplines and expertise that may be appropriate for this research
project are health promotion and health education, obesity and weight
management, body composition measurement, physical activity measurement and
intervention, exercise physiology, nutrition, behavioral and social science,
pediatric medicine, preventive medicine, cardiovascular epidemiology,
educational technology, and instructional design.  Field Center applicants are
expected to propose multi disciplinary teams.

Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and eligible
agencies of the Federal government.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators.

All current policies and requirements that govern the research grant programs
of the National Institutes of Health (NIH) will apply to grants awarded under
this RFA.

Awards for Field Centers and a Coordinating Center will be made under this
RFA.  The same institution may apply for both a Field Center and a
Coordinating Center award, but the applications for each must be separate, and
there must be a different Principal Investigator and staff for each to ensure
that data analysis is done independently of data acquisition and to ensure
blinding of Field Center staff.

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
substantially involved with recipients in conducting a study by facilitating
performance of the effort in a "partner" role.  Details of the
responsibilities, relationships, and governance of a study funded under a
cooperative agreement are discussed later in this document under the section
entitled TERMS AND CONDITIONS OF AWARD.

While multi disciplinary approaches are encouraged, it is not the intent of
this announcement to solicit applications for large studies encompassing a
variety individual subprojects, i.e., program projects.  If collaborative
arrangements through subcontracts with other institutions are planned, consult
the program staff listed under INQUIRIES.

FUNDS AVAILABLE

An estimated four awards for Field Centers and one award for a Coordinating
Center will be made under this RFA.  A maximum of $24.4 million (including
Direct costs and Facilities and Administrative costs) will be awarded for
Field Centers and the Coordinating Center with about 80% apportioned to the
Field Centers.  Approximately $1.2 million will be available for the first
year, $2.2 million for the second year, $2.7 million for the third year, $4.2
million for the fourth year, $4.6 million for the fifth year, $4.7 million for
the sixth year, $4.3 million for the seventh year (final year for Field
Centers), and $0.44 million for the last year (Coordinating Center only). 
Field Center applicants may request up to 7 years of support.  Coordinating
Center applicants may request up to 8 years of support.

Applicants are expected to furnish their own estimates of time required to
achieve the objectives of the proposed research project.  Since a variety of
approaches would represent valid responses to this RFA, it is anticipated that
there will be a range of costs among individual grants awarded.

Awards and level of support are 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.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be submitted and reviewed according to the customary peer
review procedures.  It is anticipated that support for this project will begin
on April 1, 1999.  Administrative adjustments in project period and/or amount
may be required at the time of the award.

RESEARCH OBJECTIVES

Background

The high prevalence of obesity in Black women may be a contributing factor to
their higher mortality from cardiovascular disease and higher prevalence of
diabetes and hypertension compared with White and Hispanic women (Fingerhut
and Warner, 1997).  Although Hispanic women also exhibit high prevalence of
obesity, mortality from heart disease is less than for Black or White women
and mortality from diabetes is less than for Black women (Fingerhut and
Warner, 1997).

The increased prevalence of obesity in Black females is present during
childhood, and the prevalence of obesity is increasing faster in Black girls
than in White girls.  Recent data from the third National Health and Nutrition
Examination Survey (NHANES III) showed that during preadolescence, age 6-11
years, 30.7 % of Black girls, compared with 22.0% of White girls, were
overweight (Troiano et al, 1995).  Furthermore, over the past 30 years the
prevalence of obesity in this preadolescent age group has increased 150% in
Black girls, compared with 40% in White girls (Troiano et al, 1995).  The
prevalence of obesity in the adolescent age of 12-17 years is similarly high,
at 29.9% in Black girls compared with 20.7% in White girls.  The 35% increase 
in obesity over the past 30 years is similar in the preadolescent and
adolescent age groups for White girls, but for Black girls the increase is
greater in the younger age group (150% more prevalent) than in the older age
group (80% increase).

Obese children are at high risk of becoming obese adults.  Risk ratios of 2.0
to 6.5 have been estimated from several studies, indicating the risk of an
obese child becoming an obese adult is up to 6.5 times higher than that of a
non-obese child becoming an obese adult (Serdula et al, 1993).  During puberty
fat accumulation accelerates in girls (Malina and Bouchard, 1991; Foster et
al, 1977), and at age 12, the average age of menarche, greater increases in
adiposity as measured by sum of three skinfolds are observable in Black girls
compared with White girls (Kimm et al, 1994).  As in adults (Liu et al, 1996,
Denke et al, 1993), cardiovascular disease risk factors such as blood
cholesterol and blood pressure are associated with increased weight in
children (Smoak et al, 1987; Williams et al, 1992), and unfavorable changes in
cardiovascular disease risk factors have been associated with increases in
weight in children (Clarke et al, 1986; Freedman et al, 1985).  Because Black
women have a high prevalence of obesity and other conditions that are
ameliorated by weight loss, such as hypertension and diabetes, obesity
prevention efforts directed at Black girls have potential long-term health
benefits.

It is generally agreed that the etiology of obesity is multifactorial.  Excess
energy intake and/or insufficient energy expenditure contribute to energy
imbalance which results in obesity.  Eating and physical activity behaviors,
psychosocial factors, socioeconomic status, and family and environmental
influences are associated with obesity and behaviors related to obesity.  In
addition, data have been accumulating that genetic factors strongly influence
adiposity (Bouchard and Perusse, 1993).  Research on mouse and rat genes and
their mutations as well as on the leptin receptor has propelled the search for
human obesity genes.  Determining the effect of genetic polymorphisms on the
response of weight to intervention is important to help explain individual
variation in responsiveness and to help target future intervention efforts to
individuals at risk for obesity.

Treatment Programs:  Achieving long-term weight loss has long been a difficult
and elusive goal in adults (Kramer et al, 1989), and there is evidence that
adult Black women are less successful in achieving weight loss than White
women (Kumanyika et al, 1991).  Weight loss in children also is difficult to
achieve, and there are potential safety concerns in promoting weight loss in
growing children.  Weight loss efforts may compromise children's nutritional
status, and dieting has been linked to eating disorders, especially in girls
(French et al, 1995).  It was recently reported that by age 9-10 years, 40% of
Black and White girls are trying to lose weight (Schreiber et al, 1996). 
Although successful long-term weight loss in children has been reported in
clinic-based studies (Epstein et al, 1984; 1990; Davis and Christoffel, 1994),
and in shorter term school-based studies of obese children (Resnicow, 1993),
most studies were successful at best in the short term and much of the weight
lost was subsequently regained in the longer term.  Many weight loss studies
have had large drop-out rates, where approximately only half of the original
sample returns for follow-up visits.

Prevention of Obesity: The possibility that healthful behaviors learned in
childhood may be sustained through adulthood makes prevention activities
targeted at children especially appealing and potentially cost-effective. 
Promoting optimal weight and preventing obesity by promotion of healthful
eating and physical activity habits in children has been recommended by
several public health organizations and investigators (USDA, 1995; American
Academy of Pediatrics, 1992; Troiano et al, 1995).  However, few studies have
tested obesity prevention efforts.  Prevention-oriented interventions have
been tried in school-based studies (Donnelly et al, 1996) and have not focused
specifically on obesity prevention but rather have promoted healthful eating
behaviors, primarily reducing dietary fat intake, and/or increasing physical
activity.  In general no effects on weight have been observed (Resnicow, 1993;
Leupker et al, 1996).

Few non-school-based studies aimed at obesity prevention in children have been
conducted.  A 6-week obesity prevention pilot study tested a community-based
tutoring program based on social learning theory in 24 low-income Black girls,
age 8-12 years, and their mothers.  Although favorable effects were found in
fat intake in the girls and their mothers compared to the control group,
assessment of the effectiveness of decreasing weight gain was precluded
because of the short time frame of 6 weeks (Fitzgibbon et al, 1995). 
Subsequently, a 12-week program conducted by the same research group reported
favorable changes in total dietary fat and saturated fat in the mothers and
saturated fat in the daughters, but no differences in weight were reported
between the intervention and control groups at 12 weeks (Stolley and
Fitzgibbon, 1997).

Interventions to improve diet and physical activity behaviors in children have
been successful, although they have not focused on obesity prevention.  For
example, the Dietary Intervention Study in Children (DISC) successfully
decreased dietary fat consumption over 3 years in adolescents (DISC, 1995).
The most extensive and promising research on interventions for promoting
physical activity among young people has been conducted with students in
schools, primarily at the elementary school level (Resnicow, 1997).  There is
limited evidence concerning the effectiveness of community programs,
interventions in health care settings, family programs, and programs for
special populations (USDHHS, 1996).

The NIH convened a Special Emphasis Panel (SEP), "Intervention Studies in
Children and Adolescents to Prevent Cardiovascular Disease," in September
1997.  The SEP reviewed the efficacy and effectiveness of interventions to
prevent and improve known cardiovascular disease risk factors in children and
adolescents and developed recommendations for future research directions for
preventive intervention studies.  This RFA was developed in response to the
SEP's favorable and supportive review of an initiative concept.  Minutes from
the SEP can be found at www.nhlbi.nih.gov/nhlbi/ under "Meetings and Other
Information."

Because very few prevention-oriented interventions for obesity have been
developed, research to support the early phases of intervention development is
urgently needed.  Phase 1 of this program is envisioned to address this need. 
The formative research in Phase 1 will enable centers to develop interventions
and measurement instruments for low- and higher SES African-American girls
that will be tested subsequently in Phase 2.  Finally, Phase 3 (not addressed
by this RFA) is envisioned to study the dissemination of the efficacious
interventions to other populations of African-American girls, as well as to
other ethnic/racial groups after adaptation, and in various settings.

Objectives and Research Scope

The purpose of Phase 1 is to provide each Field Center with the opportunity to
develop its interventions.  Coincident with this, and with the assistance of
the Coordinating Center, will be the identification, development, and
assessment of standardized measurement methodology.  Phase 2 is for the
purpose of implementing four trials, one at each of the four Field Centers,
with the Coordinating Center assuming major responsibility for the
collaborative sections of the protocols and measurement procedures,
measurement training, quality control, data management, and analyses for the
key variables selected for standardization across all Field Centers. The Field
Centers and/or Coordinating Center are expected to carry out the following
activities during Phases 1 and 2:

Phase 1: Development and Pilot Testing

Each Field Center - independently of the other Field Centers:

1.  Conduct needs assessment and formative research including, for example,
focus groups, interviews or surveys, to design an intervention for decreasing
weight gain during puberty in African-American girls. This phase can also
include behavioral theory refinement.

2.  Demonstrate the feasibility of recruitment and retention of the target
population over the short term (e.g., 12 weeks).

3.  Demonstrate the feasibility of delivery of the intervention over the short
term (e.g., 12 weeks).

4.  Demonstrate the ability to take quality measurements for center-specific
and collaborative data that allow for process, adherence, impact, and outcome
evaluations.

5.  Demonstrate the ability of the intervention to modify knowledge,
attitudes, and other factors that affect diet and physical activity behaviors.

Each Field Center and the Coordinating Center:

6.  Work collaboratively with other awardees and the Project Office to agree
on criteria for participant eligibility and key measurement areas (e.g., at a
minimum impact and outcome evaluations and giving consideration to evaluation
of adherence and process evaluation), ways to pilot measurements, and criteria
for assessment of their reliability and/or validity.

7.  Work collaboratively with other awardees and the Project Office to agree
on the content of the collaborative database (which at a minimum contains the
key variables standardized across all sites), rights to access regarding the
collaborative data, and procedures for data analysis, reporting and
publication.

The Coordinating Center:

8.  Assist the Field Centers with standardization of measurement methodology
for the key variables (including data forms, procedures manuals, and
training), quality control of both measurement and intervention, and data
analysis.

9.  Provide administrative support to the project by coordinating meetings,
conference calls, and communications throughout Phases 1 and 2.

Phase 2:  Randomized Controlled Trials

Each Field Center:

1.  Finalize the full-scale study intervention procedures.

2.  Conduct a single-center randomized clinical trial, including recruitment,
randomization, measurement of center-specific variables (e.g., adherence and
process evaluation), and intervention delivery.

3.  Work collaboratively with other awardees, the Coordinating Center, and the
NHLBI Project Office to measure and assure quality control of the key
variables.

Each Field Center and the Coordinating Center - collaboratively with the
Project Office:

4.  Finalize the full-scale study protocols and measurement procedures.

5.  Test the efficacy of a medium-term (2-year) intervention to prevent
obesity by decreasing weight gain in high-risk African-American preadolescent
girls in a randomized clinical trial.

6.  Determine whether and to what extent medium-term reduction in weight gain
in high-risk African-American preadolescent girls results in more favorable
cardiovascular risk factors (e.g., lipids, blood pressure, fasting insulin).

7.  Determine the factors associated with successful decreased weight gain in
high-risk African-American preadolescent girls, including diet, physical
activity, and psychosocial and familial influences.  Genetic influences on
response to intervention should be assessed.

8.  Determine other effects of the intervention on biological and behavioral
parameters, such as sexual maturation, bone mass, and behaviors including
eating disorders and smoking.

The Coordinating Center:

9.  Assist the Field Centers with measurement training, quality control of
both measurement and intervention, and data analyses of the key variables
contained in the collaborative data base.

10.  Maintain a distributed data entry system and a collaborative data base.

Phase 3:  Dissemination Research

The purpose of Phase 3 may be to develop, implement, and evaluate a process
for disseminating the efficacious interventions from Phase 2 that have been
adapted for broader ethnic application, especially Hispanic.  The specific
objectives of Phase 3 would be determined after Phase 2 and would be addressed
in a future RFA.

Scientific Plan

Target Population

Sexual maturation has been found to be strongly related to adiposity (Morrison
et al, 1994).  Significant race-by-sexual maturation interaction observed in
the NHLBI Growth and Health Study suggests that adiposity increases more in
Black girls than in White girls during puberty (Kimm et al, 1997).  At age 9
approximately one-third and by age 10 approximately 70% of Black girls have
entered puberty (NGHS, 1992).  These observations suggest that intervention in
girls who are entering puberty is a promising age to target interventions to
decrease weight gain. Thus it is suggested that African-American girls, aged
8-10, be eligible for this study.  To enrich the population sample for girls
at high risk of obesity, it is suggested that girls be eligible if they have
at least one obese parent (Eck et al, 1992).  Other or alternative criteria
for selection of high-risk participants may be proposed by the applicant.  All
Field Centers will recruit participants based on standardized eligibility
criteria, agreed upon collaboratively.

Phase 1

Because there is little experience with obesity prevention interventions, it
is desirable that distinct and separate interventions be developed by each
Field Center.  Phase 1 research will be supported for 2-3 years to conduct the
evaluative research necessary for each Field Center to develop an
intervention.  The needs assessment and formative research may employ methods
such as interviews, surveys, focus groups, or key informant interviews. 
Information is envisioned to be obtained on factors hypothesized to influence
diet and physical activity behaviors that affect weight gain.  These may
include factors such as knowledge, attitudes, beliefs, self-efficacy, outcome
expectations, body image, perceptions of ideal body weight, cultural norms,
social context, and/or peer, family, social, and environmental influences. 
The rationale for the factors to be studied should be presented. 
Identification of behavioral theory to help define factors to examine is
strongly encouraged.  Field Center applicants should specify the methods to be
employed, the rationale for these methods, and how the results will be used to
develop the intervention.

Based on the evaluative research results, each Field Center will develop an
intervention which it will pilot-test for a 12-week period to demonstrate
feasibility, acceptability, and potential impact of the intervention.  The
intervention to be developed must be appropriate for testing in a randomized
controlled trial in Phase 2.  The Field Centers, along with the Coordinating
Center and Project Office, will work collaboratively to determine measurement
areas to pilot test and approaches to evaluation of the measurements tested. 
Pilot testing should be conducted in an intervention and control group
composed of girls meeting the eligibility criteria for the Phase 2 study, and
include process evaluation and measurement of intermediate factors
hypothesized to be related to diet and physical activity behaviors important
for decreasing weight gain (e.g., knowledge, skills, self-efficacy, outcome
expectations).  Applicants should specify the proposed intermediate factors,
measurement methods, and the rationale for their selection.

The theory development and formative research should be completed in 1-2 years
and pilot testing and data analysis should be completed within the third year
of funding.  It is envisioned that the average time to complete Phase 1 will
be about 2-1/2 years and that the Field Centers will collaborate to follow
similar schedules.

Phase 2

Phase 2, single-center randomized controlled trials conducted at each Field
Center, may cover a 4-5 year period: about half year of final collaborative
planning for measurement and protocol development, about 3 years to complete
the 2-year intervention which includes about a 1-year recruitment period, and
about a half year for closeout and data analysis. The protocols will be
reviewed by a Protocol Review Committee, appointed by the Director of the
NHLBI, prior to implementation of Phase 2 recruitment and intervention.  The
Coordinating Center will prepare the report to the Protocol Review Committee,
and subsequent reports to the future Data and Safety Monitoring Board.  It is
envisioned that review of the protocols would occur no later than the early
half of the third year of funding and that completion of procedures manuals
would occur at about the same time.  Recruitment would begin about midway
through the fourth year and intervention would begin shortly thereafter. 
Completion of the 2-year intervention and follow-up measurement would occur
early in the last year of the 7-year project.  The Coordinating Center will
have an additional half year for analysis.

Phase 2:  Study Design

Phase 2 would provide support for the conduct of separate randomized
controlled trials at each Field Center funded to do Phase 1 research and
having achieved Phase 1 objectives.  Each center would conduct its own
randomized controlled trial with individual assignment to intervention and
control conditions.  (In the absence of compelling reasons not to, individuals
will be the units of randomization and analysis.)  Each Field Center will have
a sample size sufficient to have high power to detect a significant effect
size difference between the intervention and control groups after 2 years of
intervention and should provide the rationale for its choice of significant
effect size difference.

Phase 2:  Eligibility and Measurements

To facilitate comparison of the effects of the interventions tested, the
collaborative effort between centers and the Project Office will include
collaboration in defining the eligibility criteria and in collecting data
using identical measurement procedures and instruments and schedules of
follow-up visits for key impact and outcome variables (at a minimum).  Common
eligibility criteria and data collection procedures may more easily allow
comparison of intervention effects across sites, and may allow for subsequent
meta-analytic approaches.  The Coordinating Center will assist the Field
Centers with standardization of measurement methodology, including data forms,
procedures manuals, training, quality control of both measurement and
intervention, and data analysis.  Field Centers may collect, manage, and
analyze data specific to their center that is in addition to the data
collected for collaborative purposes.

The primary outcome variable for Phase 2 may be body mass index (BMI), which
has been recently recommended as the measure of choice for adolescent
preventive services (Himes and Dietz, 1994).  BMI has been used in this
initiative for purposes of sample size estimation.  Alternative adiposity
outcomes may be proposed, such as skinfolds, percent body fat from
bioelectrical impedance, and/or other measures of body fat or body fat
distribution.

The effect size between the intervention and control group would be a lesser
increase in BMI by 0.75 kg/m2 (e.g., about 2-3 kg), which is similar to the
difference that has been observed previously between Black and White 9-year-
old girls over a 2-year period.  A standard deviation of the change of 1.8 is
assumed.  Thus, each Field Center is estimated to need a sample size of
approximately 120 per treatment arm.  The Coordinating Center and Steering
Committee will redetermine the sample size after all centers agree on the
primary outcome variable.

Intervening factors should be measured, including dietary intake, physical
activity, and psychosocial factors.  Because sexual maturation plays a strong
role in accumulation of body fat in girls during puberty, sexual maturation
should be measured as an explanatory variable.  Measures of candidate genes
for obesity should be included in order to test the effects of the
intervention in individuals with different genetic polymorphisms.

Secondary outcomes may include blood pressure, blood lipoproteins, blood
insulin levels, and/or safety measures such as eating disorders.  Information
collected on parents and data collection from subsamples could also be
proposed.

Phase 2:  Intervention

The goal of the intervention would be to reduce weight gain during
adolescence.  The interventions to be tested should be appropriate for a
controlled trial in which individuals are randomized.  Innovative and theory-
based interventions will be given preference.  Because children age 8-10 are
not independent, interventions that involve the family would be expected.

Interventions could be delivered in various settings, for example, pediatric
clinic, community organization, church, school, or housing development.  A
Field Center could test an intervention based on a specific theory or
behavioral approach, for example:  (1) family-based intervention requiring
attendance of a family member along with the participant and including
behavioral techniques for improving dietary and physical activity patterns in
both child and family member; (2) center-based intervention with supervised
physical activity and dietary instruction; (3) individual-based counseling
intervention which incorporates behavioral techniques; (4) group-based
intervention focusing on changing perceived social norms and including trained
peer leaders and group social support.

Additionally, a Field Center could test an intervention based on various
behavioral goals for the dietary component of the intervention (for example,
controlling total energy intake, decreasing high-fat and energy-dense foods,
and/or promoting general healthful eating habits including increased fruits,
vegetables, and whole grains) and/or for the physical activity component of
the intervention (for example, decreasing time spent in sedentary activities,
increasing moderate-intensity physical activity such as walking, incorporating
more active lifestyle into daily living, and/or increasing vigorous-intensity
exercise).  The applicant should specify the setting, behavioral approach,
behavioral goals, and any other components of the intervention proposed to be
developed.  The rationale for the intervention to be developed should be
given.

Phase 3: Dissemination Research

If the experiences and results of Phase 2 are positive, it is possible that
the most efficacious interventions would be adapted for broader audiences,
especially Hispanic children, and Phase 3 would be an evaluation of
dissemination approaches.  The dissemination process may involve development
of transportable intervention materials, an intervention manual, training
materials, and training procedures.  The investigators could train individuals
in clinical practice or community settings to implement the interventions.  It
is envisioned that evaluation of the dissemination process could be conducted
by comparing the degree of implementation and the outcomes in intervention and
comparison sites.

SPECIAL REQUIREMENTS

Upon initiation of the project, periodic meetings to encourage exchange of
information among investigators and the NHLBI will take place.  In the budget
of the grant application, travel funds for 1-1/2-day meetings 2-4 times a year
in the Washington Metropolitan DC area should be included.  Applicants should
also include a statement in their applications indicating their willingness to
participate in these meetings.  The Coordinating Center will provide the
logistical arrangements for these meetings and will schedule and sponsor
approximately monthly conference calls for telephone meetings of the Steering
Committee, as well as other project subcommittees.

Collaboration in this project for the Field Centers means their willingness to
work with the other Field Centers, the Coordinating Center and the Project
Office.  Applicants should include in their applications a statement of their
intent to share information during the intervention development phase, to
cooperate in identifying and defining key primary and secondary outcomes for
the randomized controlled trials,  to cooperatively develop procedures for
standardized measurement, and to participate in quality control procedures. 
Field Centers should state their flexibility in adapting to a common timeline,
their ability to complete tasks in a timely manner, and their intent to be in
synchrony with other Field Centers for training and data collection periods
during Phase 2.  Field Centers should state their ability to participate in a
distributed data entry system with the Coordinating Center, their approach to
blinding of  primary and secondary outcome measurements, and intent to
cooperate with the other Field Centers, Coordinating Center, and Project
Office in determining the content of the collaborative data base, prioritizing
data analyses by the Coordinating Center, and in collaborative publications. 
All applicants should state their intent to fully participate in the Steering
Committee and subcommittees and the willingness of their investigators to lead
a project committee or subcommittee.  The Field Centers will report regularly
their recruitment progress to the Project Office and Coordinating Center.

In order to ensure the timely sharing of information and materials, applicants
are requested to describe how, when, and in what manner data and materials
will be made available to the scientific community and the NHLBI.  Each plan
will be considered as part of the methodology for carrying out the research. 
As such, the adequacy of the plan, will be evaluated through the peer review
process and by program staff.  If an application is funded, the approved plan
will become a condition of the award, and compliance will be monitored
annually through the non-competitive renewal progress reports, which should
address this issue explicitly.  Upon completion of the project, Field Center
awardees are expected to put their intervention materials and procedure
manuals into the public domain/and or make them available to other
investigators for the conduct of research at no charge other than the costs of
reproduction and distribution.  Field Center applicants should include their
plans within their applications.  The Coordinating Center will describe its
plans to provide all Field Centers, the NHLBI  Project Office, and the
scientific community, with copies of final, cleaned data on electronic media
with accompanying documentation.

STUDY ORGANIZATION

The Steering Committee will be the main governing body of the project and, at
a minimum, will be composed of the Principal Investigators (PIs) of the Field
Centers, the PI of the Coordinating Center, and the NHLBI Project Scientist
(Prevention Scientific Research Group, DECA).  Each center and the NHLBI will
have one vote.  The Committee may meet as often as 3 times in the first 12
months of the project, equally often in the third year of the project (prior
to implementation of Phase 2) and one to two times in other years.  In
addition, it may convene monthly conference calls.  All major scientific
decisions will be determined by majority vote of the Steering Committee.  The
Chairperson, who will be other than an NHLBI staff member, should be selected
in a process assisted by the Project Office 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 Scientist.  Although each Field Center
will be responsible for its own unique protocol, the Steering Committee will
have primary responsibility for the development of the common prototype for
the measurement and data management sections and eligibility criteria.  It
will also have primary responsibility for facilitating the conduct of the
trials and reporting the project's results.  Subcommittees of the Steering
Committee will be established as necessary and may include Measurement and
Quality Control, Project Coordinators, Intervention, and Eligibility and
Recruitment.  The NHLBI may have representatives on each subcommittee.

The collaborative sections of the protocols, as mentioned above, will be
developed by the Steering Committee, assisted by Coordinating Center staff. 
These sections will define rules regarding access to data, which will be
managed through a distributed data entry system, and publications.  A Data and
Safety Monitoring Board (initially a Protocol Review Committee), to be
appointed by the NHLBI, will review progress at least annually and report to
the NHLBI.  The Coordinating Center will be responsible for developing the
reports for the DSMB and for assuming the costs of PRC/DSMB meetings.

It is required that a Data and Safety Monitoring Board (DSMB) be established
to monitor data and oversee patient safety in clinical trials.  The DSMB is an
operational component of National Heart, Lung, and Blood Institute (NHLBI)
trials.  Its charge is to periodically monitor baseline, adverse effects, and
response variable data, and to evaluate clinic and coordinating center
performance.  It has the responsibility to recommend whether the study should
continue, whether the protocol should be modified, or whether there should be
early termination.  Thus, its ethical responsibilities to the participants, as
well as to the integrity of the study, are of paramount importance to the
NHLBI.  Members will be appointed by the Director, NHLBI.  The DSMB will
provide reports to the Institute through an Executive Secretary (usually the
NHLBI Project Officer).  The Chairperson of the Steering Committee of the
study, the Principal Investigator of the Coordinating Center, and the NHLBI
Project Officer (Program Administrator for Grants) will attend meetings of
this Board.  Progressions from protocol development to participant enrollment
is dependent upon the favorable recommendation of a Protocol Review Committee
(a distinct entity from the DSMB but usually with substantially overlapping
membership) and the approval of NHLBI.

TERMS AND CONDITIONS OF AWARD

The cooperative agreement is an award instrument establishing an "assistance"
relationship (in contrast to an "acquisition" relationship) between NHLBI and
a recipient, in which substantial NHLBI scientific and/or programmatic
involvement with the recipient is anticipated during performance of the
activity.  The NHLBI purpose is to support and/or stimulate the recipient's
activity by involvement in and otherwise facilitating the activity in a
"partner" role, but avoiding a dominant role, direction or prime
responsibility.  The terms and conditions, below, elaborate on these actions
and responsibilities, and the awardee agrees to these collaborative actions
with the NHLBI Project Scientist toward achieving the project objectives.  It
is anticipated that these terms and conditions will enhance the relationship
between the NHLBI staff and the Principal Investigator(s), and will facilitate
the successful conduct and completion of the study.  These agreements will be
in addition to, and not in lieu of, the relevant NIH procedures for grants
administration.  The terms and conditions will be as follows (with "trial"
referring to a single-center randomized controlled trial conducted by a Field
Center awardee and "project" referring to the collaborative activities among
awardees called for in the RFA):

1.  The awardee(s) will have lead responsibilities in all aspects of their
trials and the project, including any modification of trial designs, conduct
of the trials, quality control, data analysis and interpretation, preparation
of publications, and collaboration with other investigators, unless otherwise
provided for in these terms or by action of the Steering Committee.

2.  The NHLBI Project Scientist will serve on the Steering Committee; she or
another NHLBI scientist may serve on other project committees, when
appropriate.  The NHLBI Project Scientist (and the other cited NHLBI
scientists) may work with awardees on issues coming before the Steering
Committee and, as appropriate, other committees, e.g., recruitment,
intervention, follow up, quality control, adherence to protocol, assessment of
problems affecting the project and potential changes in the protocols of which
there will be one per Field Center, interim data and safety monitoring, final
data analysis and interpretation, preparation of publications, and development
of solutions to major problems such as insufficient participant enrollment. 
The Project Scientist will have similar responsibilities in working with each
awardee on their trial.

3.  Awardee(s) agree to the governance of the project through a Steering
Committee.  Steering Committee voting membership shall consist of the
Principal Investigators (i.e., cooperative agreement awardees) and the NHLBI
Project Scientist.  Meetings of the Steering Committee will ordinarily be held
by telephone conference call or in the Washington Metropolitan DC area.

4.  A Data and Safety Monitoring Board (DSMB) to provide overall monitoring of
interim data and safety issues will be appointed by the Director, NHLBI.  The
Steering Committee will nominate members for the DSMB.  Meetings of the DSMB
will ordinarily be held in the Washington Metropolitan DC area.  The NHLBI
Project Scientist shall serve as Executive Secretary to the DSMB.

5.  Awardees will retain custody of and have primary rights to their center-
specific and collaborative data developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH
policies.  The protocols and governance policies will call for the continual
submission of data centrally to the Coordinating Center for collaborative
database, which at a minimum will contain the key variables selected by the
Steering Committee for standardization across all Field Centers; the submittal
of copies of the collaborative datasets to each Principal Investigator upon
completion of the project; procedures for data analysis, reporting and
publication; and procedures to protect and ensure the privacy of medical and
genetic data and records of individuals.  The NHLBI Project Scientist, on
behalf of the NHLBI, will have the same access, privileges and
responsibilities regarding the collaborative data as the other members of the
Steering Committee (i.e., cooperative agreement awardees).

6.  Support or other involvement of industry or any other third party in the
trials or the project -- e.g., participation by the third party; involvement
of project resources or citing the name of the project or NHLBI support; or
special access to project results, data, findings or resources -- may be
advantageous and appropriate.  However, except for licensing of patents or
copyrights, support or involvement of any third party will occur only
following notification of and concurrence by NHLBI.

7.  Awardees are encouraged to publish and to publicly release and disseminate
results, data, and other products of the project, concordant with the project
protocols and governance, and the approved plan for making data and materials
available to the scientific community and to the NHLBI.  However, during or
within three years beyond the end date of the project period of NHLBI support,
unpublished data, unpublished results, data sets not previously released, or
other study materials or products are to be made available to any third party
only with the approval of the Steering Committee and in accordance with
paragraph 6.

8.  Upon completion of the project, Field Center awardees are expected to put
their intervention materials and procedure manuals into the public domain
and/or make them available to other investigators, according to the approved
plan for making data and materials available to the scientific community and
the NHLBI, for the conduct of research at no charge other than the costs of
reproduction and distribution.

9.  The NHLBI reserves the right to terminate or curtail the project (or an
individual award) in the event of (a) failure to develop or implement mutually
agreeable collaborative measurement, participant eligibility, and data
management sections of the protocols, (b) substantial shortfall in participant
recruitment, follow up, data reporting, quality control, or other major breech
of protocol, (c) substantive changes in the agreed-upon protocols with which
NHLBI cannot concur, (d) reaching a major project outcome substantially before
schedule with persuasive statistical significance, or (e) human subject
ethical issues that may dictate a premature termination.

10.  Any disagreement that may arise in scientific/programmatic matters
(within the scope of the award) between award recipients and the NHLBI may be
brought to arbitration.  An arbitration panel will be composed of three
members -- one selected by the Steering Committee (with the NHLBI member not
voting) or by the individual awardee in the event of an individual
disagreement, a second member selected by NHLBI, and the third member selected
by the two prior members.  This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CRF part 50, Subpart D
and HHS regulation at 45 CRF part 16 or the rights of NHLBI under applicable
statutes, regulations and terms of the award.

11.  These special terms of award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR part 74, and other HHS, PHS, and NIH grant
administration policy statements.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should follow
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 in the NIH Guide for Grants and Contracts of
March 18, 1994, Volume 23, Number 11.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 18, 1998, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.  Although a
letter of intent is not required, is not binding, and does not enter into the
review of subsequent applications, the information that it contains allows
NHLBI staff to estimate the potential review workload and to avoid conflict of
interest in the review.

The letter of intent is to be faxed or sent to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7216
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541
Email:  [email protected]

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used in
applying for these grants and the modified instructions in this RFA must be
followed.  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 Institute of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20898-7910, telephone 301-710-0267, E-
mail: [email protected].

The RFA label found 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 2 of the face page of the application form and the YES
box must be marked.

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

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be
sent to Dr. C. James Scheirer, at the address listed under LETTER OF INTENT.

Applications must be received by July 30, 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 currently pending initial
review, unless the applicant withdraws the pending application.  The CSR will
not accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

If an application is determined to be unresponsive to the RFA, it will be
returned to the applicant.

REVIEW CONSIDERATIONS

Applications will be reviewed by the CSR for completeness and by the NHLBI for
responsiveness.  Incomplete and/or non-responsive applications will be
returned to the applicant without further review.  Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by a peer review group convened by the NHLBI, in accordance
with NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a review in which
only those applications deemed to have the highest scientific merit of the
applications under review (usually two to three times the number of
applications that the NHLBI anticipates being able to fund under the program)
will be discussed, assigned a priority score, and receive a second level
review by the National Heart, Lung, and Blood Advisory Council.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  The direct costs budget request will be reviewed
for consistency with the proposed methods and specific aims.  The duration of
support will be reviewed to determine if it is appropriate to ensure
successful completion of the recommended scope of the project.

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, which
is to reflect the overall impact of the project on the field, weighing the
criteria appropriately for each application.  An application does not need to
be strong in all categories to be judged likely to have a major scientific
impact and thus deserve a high merit rating.  For example, an investigator may
propose to carry out important work, that by its nature is not innovative, but
is essential to move a field forward.

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 method? 
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
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

The following will be considered in making funding decisions: scientific merit
as determined by peer review, availability of funds, and program priority.

The anticipated date of award is April 1, 1999.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Marguerite Evans, M.S., R.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8126
Bethesda, MD  20892-7936
Telephone:  (301) 435-0380
FAX:  (301) 480-1669/1773
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Marie A. Willett
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0148
FAX:  (301) 480-3310

AUTHORITY AND REGULATIONS

This program 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 Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or a Health
Systems Agency Review.

The Public Health Service (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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