CULTURALLY SENSITIVE INTERVENTION STRATEGIES FOR PROMOTING ORIMPLEMENTING COMPLIANCE WITH NCI DIETARY GUIDELINES AMONG AFRICAN AMERICANS NIH GUIDE, Volume 23, Number 5, February 4, 1994 PA NUMBER: PA-94-033 P.T. 34, FC Keywords: Nutrition/Dietetics Cancer/Carcinogenesis Health and Safety Education National Cancer Institute PURPOSE 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. 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 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 202-783-3238). ELIGIBILITY REQUIREMENTS 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. MECHANISM OF SUPPORT 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. RESEARCH OBJECTIVES 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 apply. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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 policies. APPLICATIONS PROCEDURES 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 301/710-0267. 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** REVIEW CONSIDERATIONS 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. AWARD CRITERIA 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 decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES 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 AUTHORITY AND REGULATIONS 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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