NIH GUIDE, Volume 23, Number 5, February 4, 1994

PA NUMBER:  PA-94-033

P.T. 34, FC




  Health and Safety Education 

National Cancer Institute


The National Cancer Institute (NCI) invites applications for studies

to develop and evaluate the effectiveness of culturally sensitive

intervention strategies to assist African Americans in adopting

eating patterns consistent with the NCI Dietary Guidelines.


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 PA,

Culturally Sensitive Intervention Strategies for Promoting or

Implementing Compliance with NCI Dietary Guidelines Among African

Americans, is related to the priority area of cancer.  Potential

applicants may obtain a copy of "Healthy People 2000" (Full Report:

Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report:

Stock No. 017-001-00473-1) through the Superintendent of Documents,

Government Printing Office, Washington, DC 20402-9325 (telephone



Applications may be submitted by non-profit and for-profit

organizations and by public and private entities such as

universities, colleges, hospitals, laboratories, units of state or

local governments, and eligible agencies of the federal government.

Applications from minority investigators and women are encouraged.

Foreign organizations are ineligible to apply.


Support mechanisms for this program announcement will be the research

project grants (R01) and First Independent Research Support and

Transition (FIRST) Award (R29).  Because the nature and scope of the

research proposed in response to this PA may vary, it is anticipated

that the size of an award will vary also.


Epidemiological as well as laboratory evidence over the past 20 years

indicates significant correlations between diet and specific cancers,

including breast, colorectal, prostate, oral cavity, stomach,

esophageal, and possibly lung.  It has been estimated that 35 percent

(10 to 70 percent) of all cancer deaths may be attributed to diet.

The NCI dietary guidelines suggest dietary changes that may decrease

an individual's risk for cancer.  This concept addresses three of the

NCI dietary guidelines:  (a) Reduce fat intake to 30 percent or less

of calories; (b) Increase fiber intake to 20 to 30 grams daily, with

an upper limit of 35 grams; and (c) Include a variety of vegetables

and fruits in the daily diet.  The NCI dietary guidelines for cancer

prevention are relevant to several of the national health promotion

and disease prevention objectives for nutrition and cancer reduction

outlined in the Healthy People 2000 report (1990).

Comparison of African Americans' dietary intake patterns to the NCI

guidelines indicate deficiencies.  For example, the daily fat intake

among African Americans in two studies was 36.0 percent of

kilocalories.  The mean daily intake of fiber was 8.0 grams for

African American females.  They were eating less than three servings

of vegetables daily.  In addition, they were consuming less than two

servings of fruits and juices.

Conventional dietary and weight change programs are not well suited

to the special needs of African Americans because they neglect to

incorporate relevant cultural features.  Cultural variables are

seldom considered in behavioral change program design and

implementation.  However, culture influences various aspects of life,

including food preferences and ideas about disease causation.  But,

few conventional weight loss and dietary change programs have

considered African Americans' special needs.

This program announcement has four major research objectives:  (1) To

identify barriers and motivators of dietary change among African

Americans; (2) To develop culturally sensitive intervention

strategies to increase knowledge and promote attitude and

dietary/behavior change among African Americans; (3) To evaluate the

effectiveness of these culturally sensitive dietary/behavior

intervention strategies on achievement and adherence to the NCI

dietary guidelines; and (4) To examine the effect of dietary changes

on selective biochemical and anthropometric parameters, such as serum

lipids, estradiol, body mass index, and waist to hip ratio.

Investigators will be encouraged to summarize and publish process and

outcome results from these studies for use by community-level

organizations that serve African Americans.  Intervention sites may

include, but are not limited to, various African American religious,

professional, medical/nursing, social, public housing organizations,

and community health centers as well as worksites, and businesses.

Interventions may target individuals, households, groups, and/or

organizations.  Two types of evaluation should take place under this

PA:  (1) process evaluation to identify ways of improving the program

and determine how much of the program is being implemented as

planned; and (2) outcome evaluation to judge how effectively the

intervention strategies have worked.  Investigators will be required

to provide full details of how they intend to accomplish these types

of evaluation, and how they will recruit and retain study subjects.

A variety of culturally sensitive intervention strategies rather than

a single approach should be used and should be adapted to the special

needs of African Americans to provide them with the skills they need

to make dietary change.  Multidisciplinary teams are encouraged to






NIH policy is that applicants for NIH clinical research and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder, or condition under

study; special emphasis must be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information must be included in the form PHS 398

(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in

Section 5, Human Subjects.  Applicants are urged to assess carefully

the feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans (including American Indians or Alaskan

Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale

for studies on single minority population groups must be provided.

For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies or etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.  The usual policies concerning research on human

subjects also apply.  Basic research or clinical studies in which

human tissues cannot be identified or linked to individuals are

excluded.  However, every effort should be made to include human

tissues from women and racial/ethnic minorities when it is important

to apply the results of the study broadly, and this should be

addressed by applicants.

If the required information is not contained within the application,

the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning a priority score to the application.

All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  Application kits are

available at most institutional offices of sponsored research and may

be obtained from the Office of Grants Information, Division of

Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301/435-0714.  The title and

number of this announcement must be typed in Section 2a on the face

page of the application.

Applications for the FIRST Award (R29) must include at least three

sealed letters of reference attached to the face page of the original

application.  FIRST Award (R29) applications submitted without the

required number of reference letters will be considered incomplete

and will be returned without review.

The completed original application and five legible copies must be

sent or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be assigned on the basis of established Public

Health Service referral guidelines.  Applications will be reviewed

for scientific and technical merit by study sections of the Division

of Research Grants, NIH, in accordance with the standard NIH peer

review procedures.  Following study section review, the applications

will receive a second-level review by an appropriate national

advisory council.


Applications will compete for available funds with all other

applications assigned to that ICD and recommended for further

consideration.  The following will be considered in making funding


o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement


Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jacqueline Whittted, Ph.D.

Division of Cancer Prevention and Control

National Cancer Institute

Executive Plaza North, Room 232

Bethesda, MD  20892-4200

Telephone:  (301) 496-8584

Direct inquiries regarding fiscal matters to:

Kathleen Shino

Division of Grants Administration

National Cancer Institute

Executive Plaza South, Room 243

Bethesda, MD  20892-4200

Telephone:  (301) 496-7800  ext. 48


This program is described in the Catalog of Federal Domestic

Assistance No. 93.399, Cancer Control.   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 and 92.  This program is not

subject to the intergovernmental review requirements of Executive

Order 12372 or Health Systems Agency review.


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