Subject: RFAHl-90-11-P.070690
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 05 Jul 90 09:18 EST

Hello Paul!
This is the RFA for the July 6 NIH Guide.
Please post to the listserver as: RFAHl-90-11-P.070690.
Thanks,
Dottie
 ---------------------------- Text of forwarded message -----------------------
     
REQUEST FOR RESEARCH GRANT APPLICATIONS:  HL-90-11-P
     
CVD NUTRITION EDUCATION FOR LOW LITERACY SKILLS
     
P.T. 34; K.W. 0710095, 0502028, 0715040, 0411005
     
National Heart, Lung, and Blood Institute
     
Letter of Intent Receipt Date:  August 15, 1990
Application Receipt Date:  October 16, 1990
     
PURPOSE
     
The immediate objective is to develop and validate a
nutrition education program designed to reduce cardiovascular
disease (CVD) risk factors related to nutrition (elevated
blood cholesterol, moderately elevated blood pressure, and
obesity) in at-risk adults with low literacy skills.  The
long-term objective is to provide health professionals with
nutrition intervention programs for this underserved
population.
     
DISCIPLINES AND EXPERTISE
     
Participation from various members of the health care team
(such as physicians, nutritionists, nurses, educators,
behavioral scientists, including cognitive, social, and
clinical psychologists) as well as specialists in
communication, educational technology, and instructional
design is sought.  The initiative is limited to education in
the English language.  Ultimately, results of this research
would provide information so that similar research
initiatives for persons who speak other languages could be
developed.
     
BACKGROUND
     
Cardiovascular diseases cause almost one million deaths each
year; 73.1% are due to atherosclerosis.  Heart disease is the
leading cause of death; the main form is coronary heart
disease (CAD), which caused 524,000 deaths in 1986 (NHLBI
Fact Book, 1987).  Hypercholesterolemia, hypertension and
smoking are established risk factors for CAD, and often these
risk factors are found in combination in the same individual.
Persons with only one of these risk factors show a two to
four times increase in the incidence of CAD; the combination
of two of these risk factors has been found to increase the
incidence of CAD by as much as nine times, and by as much as
16 times when all three of these risk factors are present.
The necessity of both prevention and treatment of the risk
factors of CAD is apparent.
     
The estimates of the level of "illiteracy" in the United
States varies with the definition used.  Based on the 1982
United States Bureau of Census English Language Proficiency
Survey about 13% (17-21 million) of Americans aged 20 years
and older are "functionally illiterate" (4th grade readers or
less) and another 70 million are "marginally illiterate"
(5th-8th grade readers).  The population of functionally
illiterate grows by an estimated 2.3 million persons each
year.
     
Although low-level readers are found in all socioeconomic and
racial groups (more whites than minorities are functionally
illiterate), a greater proportion of minority populations are
classified as functionally illiterate (44% blacks, 56%
Hispanics).  Minorities also manifest a high prevalence of
cardiovascular risk factors.  Disparity in the death rate
between non-minority and minority populations was highlighted
by the 1985 Report of the Secretary's Task Force on Black and
Minority Health [Department of Health and Human Services
(DHHS)].  It noted that many of the identified behavioral
and environmental risk factors associated with the causes of
excess deaths among minorities can be controlled; more work
is needed to educate minority populations about the risk
factors having the greatest impact on minority health.  One
of those areas is cardiovascular disease.  The report
stressed that the DHHS should ensure that patient education
materials and programs should be suitable for specific
groups.  The report also stated that programs should prepare
and test health education materials that are sensitive to
various minority cultures and appropriate to their language
and reading level.
     
Current recommendations for reduction of several CVD risk
factors -- elevated blood cholesterol, elevated blood
pressure and obesity -- stress dietary treatment.  The Adult
Treatment Panel Guidelines for the Detection and Evaluation
and Treatment of High Blood Cholesterol includes weight
reduction and dietary fat modification for reducing blood
cholesterol.  The Joint National Committee for the Control of
High Blood Pressure advises diet modification for weight loss
and sodium restriction among the treatments for
hypertension.  If drug management is undertaken, dietary
treatment is still to be included.  To implement these
recommendations most effectively, the education programs and
materials must be appropriate for the target audiences.  The
NHLBI has supported numerous nutrition education programs in
which dietary changes for risk factor reduction have been
achieved, such as the National Diet Heart Study, the Multiple
Risk Factor Intervention Trial, the Hypertension Control
Program, and the Dietary Intervention Study in Hypertension.
However, these programs were developed for highly literate
populations and are not appropriate for all persons in the
general population.  Methods and materials used in individual
and group counselling in these and other projects rely
heavily on printed materials for initial counselling and for
reinforcement.
     
Results of the National High Blood Pressure Education Program
telephone survey of 4,000 adult respondents in 1982 revealed
that 12% (458) of the respondents reported they had been
advised to go on a low-salt or low-sodium diet.  (This advice
was received by a higher proportion of persons with
hypertension, females and persons 50 years of age and older.)
It indicated that health professionals provided written
instructions or diet plans to almost one-half (46%) of the
patients advised to restrict their salt intake.  As for
educational attainment, 52% of the group receiving written
material were not high school graduates.  Blacks reported
receiving advice more frequently from their health
professionals on ways to shop or cook to reduce sodium than
did whites (57% vs. 30%).  Overall, however, respondents
reported receiving advice on shopping and cooking less
frequently than diet plans.  It appears that health
professionals may be tailoring their advice concerning
reading food labels to the educational level of the patient.
Of the one-fifth reported receiving such advice, those with
high school and college education were given sodium labeling
advice almost twice as frequently (23%) as were those with
less than a high school education (13%).  Therefore, it would
appear that the latter group may be at a disadvantage in
buying appropriate food to decrease sodium intake.
     
Limited reading skills hamper the ability of a large number
of adults to understand written nutrition information; yet
this is the traditional means by which this information is
conveyed.  Patients with limited reading skills are found in
public health settings and ambulatory care facilities as
well as in hospitals.  The extent to which patient health
educators assess reading levels accurately before delivering
nutrition information, and the methods they use to accomplish
this, is unknown.
     
A 1979 study by Doak and Doak at the USPHS Hospital in
Norfolk, Virginia, assessed the match between the literacy
requirements of the health instructions used with the
literacy skills of patients.  They collected 100
instructional items and found that the mean reading level
required to understand them was at the 10th grade level.  The
patients tested had mean word-recognition skills at the
seventh grade level, indicating a gross mismatch between the
level of difficulty of the materials and the word-
recognition ability of the patients.  The results of the
Diabetes Control Project of the South Carolina Department of
Health and Environmental Control, l980-8l, which replicated
the Doak study, were similar.
     
In the broader area of consumer economics and health, 20 to
30% of the adults in the U.S. are severely limited by low
literacy skills.  According to material prepared by the
College of Agricultural and Life Sciences, University of
Wisconsin, 58 million Americans do not have skills adequate
to perform basic tasks such as reading food labels.
Comprehension may be limited due to limited vocabulary or
perception and/or differences in ability to organize
thoughts.  The situation is aggravated by the rapid advances
being made in many industries.  As new technology and new
products raise the basic language skills necessary for
survival, more and more people fall behind by not being able
to keep up with the increased demands of our culture.  Under
present conditions, which include a high rate of children
dropping out of school, the number of people with limited
reading skills is growing.
     
Needs for research in this area include:
     
l.  Adaptation of known methods to identify and classify
adults with low literacy skills so that nutrition educators
can use appropriate strategies.
     
2.  Identification or development of innovative nutrition
education methods and materials for adults with low literacy
and CVD risk and evaluation of these materials for
comprehension and applicability in varied health care
settings.
     
3.  Studies to test the efficacy of programs using these
approaches.  These should include identification of
environmental factors which may have a negative or positive
impact on learning and dietary compliance, and the assessment
of the influence of individual differences (e.g., age,
socioeconomic factors, literacy, attitude, social support) on
behavior change.
     
OBJECTIVES AND SCOPE
     
This solicitation is intended to simulate research that will
result in the development of innovative methods and materials
to modify cardiovascular risk factors related to nutrition
(elevated blood cholesterol, moderately elevated blood
pressure, and obesity) in adults with low literacy skills.
The scope of these research projects should include all of
the following:
     
l.  Development or adaptation of nutrition education modules in
the English language for adults with low literacy skills,
including materials that can be tested for their ability to
effect change in food habits.
     
2.  Clear definition of measurable outcomes, behavior changes
(e.g. assessment of food and nutrient intake, urinary
sodium), knowledge change and physiological changes (e.g.
blood cholesterol, blood pressure, weight change).
     
3.  Depending upon the risk factors selected, modules should be
tested for independent (i.e. sodium reduction or fat
modification) or combined (sodium and weight reduction or fat
modification and weight reduction) effects.
     
4.  Reliable and valid assessments of literacy levels.
     
5.  Attention to sample-size estimations which will allow for
characterization of the population examined and the ability
to test the proposed educational modules.
     
6.  Randomization of patients into study groups such as "Usual
Care" (e.g. verbal instructions or handouts of already
available printed educational materials) and "improved" or
"innovative care" representing different levels of
intervention and educational methods (e.g. food or product
demonstrations, food selection, interactive computer programs
or other audiovisual techniques).
     
7.  Programs and materials for effecting change in blood
cholesterol, blood pressure and obesity that are consistent
with recommendations of the National Cholesterol Education
Program's Expert Panel on Detection, Evaluation and Treatment
of High Blood Cholesterol in Adults and with the report and
recommendations of the Joint National Committee on Detection,
Evaluation, and Treatment of High Blood Pressure (IV).
     
8.  Formative evaluation of the programs or materials as they
are developed to determine their applicability to the target
population.
     
9.  Summative evaluation of developed programs or materials
to assess their ability to reduce
cardiovascular risk factors in the target populations.
     
10.  Successfully tested programs and materials that are in a
form suitable for widespread dissemination to other health
professionals and health care settings.  Preliminary plans
for how materials would be disseminated should be included.
     
11.  Grantees will be expected to participate in annual
meetings in Bethesda, Maryland, to collaborate on
standardization of  assessment instruments and formative and
summative evaluations.
     
Additionally, projects could include the following:
     
1.  Assessment of costs to implement the nutrition education
program.
     
2.  Identification and assessment of individual and
environmental factors related to learning and compliance to
dietary change.
     
EXCLUSIONS
     
Awards to foreign institutions will be made only in cases of
exceptional merit or promise, or where unique capabilities
are evident, and in accordance with relevant PHS policies.
     
INCLUSION OF WOMEN AND MINORITIES
     
The NIH urges applicants for grants and cooperative
agreements to give added attention (where feasible and
appropriate) to the inclusion of women and minorities in
study populations for research into the etiology of diseases,
research in behavioral and social sciences, clinical studies
of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate
interventions for disease and disease prevention and health
promotion. If minorities and women are not included in a
given study falling into one of these areas, a clear rationale
for their exclusion should be provided.
Investigators are
reminded that merely including arbitrary numbers of women
and/or minority group participants in a given study is not
sufficient to guarantee generalization of the results.
     
MECHANISM OF SUPPORT
     
The mechanism for this program will be the traditional,
individual, research-project grant.  Although the financial
plans for fiscal year 1991 include approximately $1,000,000
for the total costs (direct and indirect) of this program,
support of grants pursuant to this Request for Applications
(RFA) is contingent upon
receipt of funds for this purpose.  It is anticipated that
approximately three or four grants will be awarded under this
one-time solicitation.  The specific number to be funded
will, however, also depend on the merit and scope of the
applications received and their relevance to the program
objectives.  Since a variety of valid approaches are
appropriate in response to this announcement, it is
anticipated that there will be a range of costs among the
individual grants awarded.
     
Upon initiation of the program, the Prevention and
Demonstration Research Branch will sponsor periodic meetings
to encourage exchange of information among investigators and
collaboration on standardization of assessment instruments
and formative and summative evaluations.  In the preparation
of the budget for the grant application, applicants should
request travel funds for a two-day meeting each year, most
likely to be held in Bethesda, Maryland.  Applicants should
also include a statement in their application indicating
their willingness to participate in such meetings.
     
Applicants are requested to furnish their own estimates of
the time required to achieve the objectives of the proposed
research project; however, the award period for this activity
must not exceed five years.  At the end of the initial award
period, renewal applications may be submitted for further
competitive review through the regular grant program of the
NIH.  It is anticipated that support for this program will
begin in August 1991.
     
The current policies and requirements that govern the
research grant programs of the PHS will prevail, including
the institutional requirements for safeguarding the welfare
of animals and the rights of human subjects who participate
in the proposed studies.
     
REVIEW PROCEDURES AND CRITERIA
     
Review Method.  All applications responding to this RFA will
be reviewed for scientific and technical merit by an initial
review group, which will be convened by the Division of
Extramural Affairs, NHLBI, solely for this purpose.  Upon
receipt, applications will be reviewed for their
responsiveness to the objectives of this RFA.  If an
application is judged unresponsive at this stage, the
applicant will be contacted and given an opportunity to
withdraw the application  or to have it considered for the
regular research grant program of the NIH.
     
If the proposal submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but which has not yet been
reviewed, the applicant will be asked
to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be
allowed nor will essentially identical applications be reviewed
by different review committees.  This does not preclude the submission
of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.
     
Review Criteria.  The factors to be considered in the
evaluation of scientific merit of each application will be
similar to those used in the review of traditional research
project applications, including: the scientific merit of the
proposed project, including the novelty, originality, and the
feasibility of the approach and adequacy of the experimental
design; the competence and commitment of the investigator(s);
the adequacy of the laboratory, clinical facilities,
instrumentation and data management systems to carry out the
proposed design; the institutional commitment; and the
appropriateness of the budget.
     
METHOD OF APPLYING
     
Letter of Intent
     
Prospective applicants are asked to submit a one-page, non-
binding letter of intent that includes identification of
other participating institutions or investigators.  The
Institute requests such letters only for the purpose of
providing a indication of the number and scope of the
applications to be received and, therefore, usually does not
acknowledge their receipt.  A letter of intent will not enter
into the review of any application subsequently submitted,
nor is it a necessary requirement for application.
     
This letter should be received no later than August 15, 1990,
and sent to:
     
Dr. James C. Scheirer
Review Branch, Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
Westwood Building, Room 548
Bethesda, MD  20892
     
Format for Applications
     
Submit applications on form PHS 398 (rev. 10/88), the application for the
traditional research-project grant.  This form is available
in an applicant institution's office of sponsored research or
business office or from the Division of Research Grants,
NIH.  Use the conventional format for research-project grant
applications and ensure that the points identified in the
section of "Review Procedures and Criteria" are fulfilled.
     
To identify the application as a response to this RFA, check
"yes" on Item 2 of page 1 of the application form and enter
the title "CVD Nutrition for Low Literacy Skills", and the
RFA number HL-90-11-P.
     
The RFA label available in the PHS Form 398 (rev. 10/88) must
be affixed to the bottom of the application face page.  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.
     
Application Procedure
     
Send or deliver the completed application and four (4)
signed, exact copies to:
     
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892**
     
Send an additional two (2) copies of the application to Dr.
James C. Scheirer at the address listed under Letter of
Intent.
     
Applications must be received by October 16, 1990.
     
Timetable
     
Letter of Intent:                  August 15, 1990
     
Application receipt date:          October 16, 1990
     
Review by the National Heart,
Lung, and Blood Advisory Council:  August 1991
     
Anticipated Award Date:            June 1, 1991
     
Inquiries
     
Inquiries regarding this announcement may be directed to:
     
Dr. Nancy C. Santanello
Prevention and Demonstration Research Branch
National, Heart, Lung and Blood Institute
Federal Building, Room 604
Bethesda, MD  20892
Telephone:  (301) 496-2465
     
The programs of the Division of Epidemiology and Clinical
Applications, National Heart, Lung, and Blood Institute, are
identified in the Catalog of Federal Domestic Assistance,
Numbers 13.837-13.839.  Awards will be made under the
authority of the Public Health Service Act, Section 301 (42
USC 241) and administered under PHS grant policies and
Federal regulations, most specifically 42 CFR Part 52 and 45
CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review.