DIET AND CARDIOVASCULAR DISEASE RISK IN CHILDREN AND ADOLESCENTS Release Date: March 25, 1998 PA NUMBER: PA-98-046 P.T. National Institute of Nursing Research National Heart, Lung, and Blood Institute PURPOSE The National Institute of Nursing Research (NINR) and the National Heart, Lung, and Blood Institute (NHLBI) seek research applications for investigator-initiated research relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at increased risk for CVD or for development of CVD risk factors because of genetics, family history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood pressure, or other factors. This program announcement (PA) seeks four different, but related, types of studies: (1) observational studies identifying determinants of nutrient intakes and determinants of dietary effects on levels of CVD risk factors, (2) intervention studies examining the effects on diet and CVD risk factors of approaches to improve dietary behavior to meet current dietary recommendations, (3) intervention studies examining the true magnitude of effects on CVD risk factors of dietary or nutrient changes under conditions of high adherence, and (4) studies directed toward advancing measurement methodologies or behavioral theories which could then be applied to intervention studies. Of particular interest is the examination of effects of dietary interventions on individuals with different genetic profiles. The overall goal of this PA is to identify dietary interventions, alone or in combination with other interventions, that can improve CVD risk factor profiles in children and adolescents. Studying male and female children and adolescents of different socioeconomic, racial, ethnic, and age groups is strongly encouraged. 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 Program Announcement (PA), Diet and Cardiovascular Disease Risk in Children and Adolescents, is related to the priority area of physical activity, nutrition, educational and community-based programs, heart disease and stroke, and children and adolescents. 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 Research applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and 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. MECHANISM OF SUPPORT The primary mechanism of support will be the National Institutes of Health (NIH) research project grant (R01); another possible mechanism is the R18 (Demonstration and Education Research). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Any applicant planning to submit a new investigator-initiated grant application requesting $500,000 or more in direct costs in any one year must contact Institute program staff before submitting the application (see INQUIRIES, below). Furthermore, the applicant must obtain agreement from Institute staff that the Institute will accept the application for consideration for award. Additional information can be found in the NIH Guide Volume 25, Number 14, May 3, 1996. Responses to Program Announcements are subject to this policy. RESEARCH OBJECTIVES Background 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; reviewed the current knowledge about emerging and new risk factors; and developed recommendations for future research directions for preventive intervention studies in children and adolescents. This PA was developed in response to panel recommendations. The minutes of the panel meeting are available at www.nih.gov/ninr and www.nhlbi.nih.gov/nhlbi/. This PA covers a wide range of topics relevant to nutrition and CVD risk factors, with a focus on children and adolescents. Dyslipidemia, obesity, smoking, hypertension, and physical inactivity have been identified as risk factors for CVD. Elevations of total blood cholesterol, body weight, and blood pressure, the onset of smoking, and a physically inactive lifestyle in childhood and adolescence increase the probability that CVD risk factors will develop in adulthood; therefore, risk reduction interventions at an early age could have life-long implications for improved health. Certain sub- populations (e.g., lower socioeconomic groups, African-Americans, those with a family history of CVD) are at increased risk for CVD or for development of CVD risk factors in adulthood. Genetic epidemiologic studies indicate that there is a significant heritability component to CVD risk. Risk reduction in populations at higher risk could contribute substantially to improving the public's cardiovascular health. Diet has been associated with eight of the ten leading causes of death in the United States. High saturated fat and high cholesterol diets increase total and LDL-cholesterol, and high levels of dietary sodium increase blood pressure. Recommendations have been made for the nation to modify and improve dietary intake, specifically to decrease dietary saturated fat, cholesterol, and sodium, and to maintain optimal weight, in order to prevent premature morbidity and mortality from CVD. However, diets of youth of the United States are high in saturated fat and sodium, and unhealthful dietary practices in childhood may contribute to such practices in adulthood. Focusing on dietary change in children and adolescents may provide substantial benefit because some studies suggest that dietary behaviors are established early. Observational studies are needed to define behavioral and social determinants of dietary practices. In addition, environmental factors, including those related to culture and SES, that influence children's and adolescents' diets in the United States need to be identified. The evidence provided by these observational studies can then be applied to development of relevant interventions. Although both population-wide (including environmental) and individual-level interventions have shown promise, additional work is necessary to develop highly effective interventions for long-term adherence to dietary changes. The effectiveness of differing approaches at differing ages and with different population groups, e.g., by SES or race/ethnicity, requires additional research. Two areas of opportunity for additional research are the school and the community because few population-wide and community interventions have been tested that have focused solely on diet. For both population-wide and individual-level interventions, nutritional adequacy of the children and adolescents should be ensured and assessed. For example, interventions that promote increased consumption of processed reduced-fat foods, or other shifts in types of foods, should assess nutritional adequacy (e.g., zinc, calcium, iron, and calories). Studies indicate that increased levels of homocysteine may play a role in the development of coronary artery disease and that elevated levels of blood homocysteine are related to deficient levels of vitamins B6, B12, and folate. The effects of vitamin supplementation and the relationship of diet and nutrition on homocysteine levels in children and adolescents need to be determined. Elevated blood pressure levels of children and adolescents predispose them to hypertension as an adult. Several micronutrients appear to be related to blood pressure levels, including sodium, potassium, calcium, and magnesium. Very little research has been conducted on the effects of macronutrients on blood pressure in children and adolescents, although macronutrients have been implicated as having effects on blood pressure in adults. Additional research needs to be conducted to determine effects on blood pressure of micronutrients obtained in foods and by supplements, of macronutrients, and of whole dietary patterns. Insufficient fetal growth and low birth weight have been hypothesized to be related to a child's later risk factors for CVD. Additional observational and intervention research is needed to define further these associations and to determine if a causal relationship exists. In order to assess the effects of interventions, self-report approaches to measuring dietary intake are often used, yet these may be biased if used in a study where participants are not blinded to their treatment assignment. Further development and validation of self-report methods for dietary assessment for use in intervention studies is needed. Biomarkers of nutrient intake and dietary adherence could be used, e.g., blood or urine measurements, yet there is a paucity of these biomarkers. More research is needed to define long-term markers as well as short-term markers of dietary intake. Short-term markers are particularly useful for intervention studies. Currently used markers include blood cholesterol to assess consumption of saturated fats, and serum carotenoids and red blood cell folate to assess consumption of fruits and vegetables. However, these markers are not precise enough for assessment at the individual level. Development of interventions often require modification of existing behavioral theories or development of new theories. Additional development and testing of new behavioral theories, specifically as applicable to children and adolescents, are needed. Objectives and Scope The applying investigator must identify the research question to be addressed, which must be related to the four types of studies identified under PURPOSE, above, to be considered a response to this PA. The investigator must provide a clear rationale for the importance of the research question and for selection of the target population to be studied. (See also REVIEW CONSIDERATIONS, below). Examples of topics for each type of study that would be responsive to this PA are provided below. Applications can address, but are not limited to, these examples. Children and/or adolescents must be the targeted population. 1. observational studies identifying determinants of nutrient intakes and determinants of dietary effects on CVD risk factors; examples include: o The identification of behavioral, social, economic, cultural, and environmental determinants of children's dietary fat intake in population groups at high risk of developing CVD as adults (e.g., minorities, low SES). o The identification of behavioral, social, economic, cultural, and environmental determinants of dietary sodium intake in African-American adolescents, who are at high risk of developing hypertension. o Identification of genetic factors that may modify the effects of diet on blood cholesterol levels, blood pressure levels, and body fat. o Elucidation of the relationships between maternal nutrition and levels of blood pressure, blood cholesterol, and obesity (or body size and composition) in offspring. 2. intervention studies examining the effects on diet and CVD risk factors of approaches to improve dietary behavior to meet current dietary recommendations; examples include: o The development and testing of behavioral interventions to change high-fat and high-sodium dietary behaviors in high-risk minority populations (for example, African-Americans, Hispanics) and in low SES groups. o The development and testing of unique interventions utilizing modern technology in various settings for reaching children and adolescents (e.g., the Internet, computer-delivered programs). o The development and testing of environmental-change interventions (such as availability of foods in the school setting, modification of fast-food restaurant offerings in the community) on the consumption of dietary fat and sodium. o The effects of fat-modified foods on adherence to lower-fat/sodium diets, including assessment of adequacy of individuals' nutritional status. o The effectiveness of behavioral interventions in individuals with high risk versus those with average risk (e.g., by informing participants of their risk status or genetic predisposition). 3. intervention studies examining the true magnitude of effects on CVD risk factors of dietary or nutrient changes under conditions of high adherence; examples include: o The effect of supplements of vitamins B6, B12, and folate on blood homocysteine levels. o The effects of micronutrient supplements on blood pressure levels. o The effects of dietary macronutrients on blood pressure levels. o The effects of various whole dietary patterns on blood pressure and blood cholesterol levels. o The effects of dietary nutrients or patterns on individuals with different genetic polymorphisms or gene frequencies that are potentially related to blood pressure, lipid profiles, adiposity, obesity, or other risk factors. 4. Studies directed toward advancing measurement methodologies or behavioral theories which could then be applied to intervention studies; examples include: o The refinement of self-report methods for measuring dietary intake and patterns. o The development and testing of biomarkers, e.g., in blood or urine, to provide more objective assessments of dietary intake. o The development or refinement of behavioral theory as relates to prediction of dietary behaviors. 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 read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) 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 Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The complete original application and five legible copies must be sent or delivered 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications will also undergo a process in which only those deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. 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: 1. 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? 2. Approach Is 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? 3. Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. 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)? 5. 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? In addition, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to that Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding scientific and programmatic issues to: Hilary D. Sigmon, PhD, RN Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: hilary_sigmon@nih.gov 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: evansm@gwgate.nhlbi.nih.gov Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12, MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: jeff_carow@nih.gov Marie Willett Grants Management Section National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7156, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0144 FAX: (301) 480-3310 Email: willettm@gwgate.nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361. 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 Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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