"FAILURE TO THRIVE" SYNDROME AMONG OLDER PERSONS NIH GUIDE, Volume 21, Number 42, November 20, 1992 PA: PA-93-22 P.T. 34 Keywords: Aging/Gerontology Nutrition/Dietetics Depression Immunology Pathophysiology National Institute on Aging National Institute of Mental Health PURPOSE Recently, a geriatric syndrome termed "failure to thrive" has been described, consisting of weight loss, decreased appetite, poor nutrition, and inactivity, often accompanied by dehydration, depressive symptoms, impaired immune function, and low serum cholesterol. Failure to thrive occurs in both acute and chronic forms, leading to impaired functional status, morbidity from infection, pressure sores, and increased mortality. This syndrome has been identified as an aging research priority in the Institute of Medicine's report: Extending Life, Enhancing Life. A National Research Agenda on Aging. (Institute of Medicine; National Academy Press, Washington, 1991.) The relationships between nutritional, metabolic and other pathophysiologic factors in failure to thrive and their effects on clinical outcomes remain to be clarified. While there is evidence that psychiatric conditions (major and subsyndromal depression and cognitive decline) are frequently associated with failure to thrive, the nature of this association needs to be clarified. "Failure to thrive" in older persons may not be a single process. It may be caused by several different pathophysiologic processes. Thus there is a strong need for descriptive information on the progression of failure to thrive in various specific groups of older persons with different chronic diseases and disabilities, to elucidate potential differences and commonalities in pathophysiologic mechanisms and clinical course. The relationship between nutritional, metabolic and other pathophysiologic mechanisms in failure to thrive, and their effects on clinical outcomes, remains to be clarified. Numerous studies have documented the extent of protein-calorie malnutrition among nursing home residents and other specific older populations. In addition, it has been suggested that micronutrient deficiencies may play a larger role in chronic debilitating changes in older persons than is currently appreciated. Alterations in endocrine factors affecting metabolism, inflammatory mediators, and depressive changes in affect have also been suggested to play a major role in failure to thrive. The contribution of specific chronic disease processes and acute conditions to failure to thrive has yet to be explored fully. The effectiveness of interventions against failure to thrive and loss of appetite in older persons has not been rigorously tested. 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), "Failure to Thrive" Syndrome Among Older Persons, is related to the priority area of aging. 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. 017-00473-1) through the superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, unit of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29) or for the Career Awards (K01, K04, K07, K08, K11, K20, K21). MECHANISM OF SUPPORT Awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The National Institute on Aging (NIA) intends to commit $1.8 million in Fiscal Year 1994 for this research area. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications in response to this announcement assigned to the NIA may not request funding over $175,000 (direct and indirect costs) for the first year, and may not request more than four percent per year above $200,000 for subsequent years. Additionally, the National Institute of Mental Health (NIMH) anticipates supporting approximately 4-6 awards under this announcement. The Principal Investigators will meet annually with NIA and NIMH staff in Bethesda, Maryland to review the progress of their studies. Funds for such travel must be requested in applications. The mechanisms for support are: o Research Grant (RO1) o FIRST award (R29) o Career awards, which include: Special Emphasis Research Career Awards (K01) in Nutritional and Metabolic Factors in Aging, Research Career Development Award (K04), Clinical Mental Health Academic Award (K07), Clinical Investigator Award (K08), Physician Scientist Award (K11), Scientist Development Award for Clinicians (K20), and Scientist Development Award (K21) RESEARCH GOALS AND SCOPE The NIA seeks applications for support of research to clarify pathophysiological features of the "failure to thrive" syndrome in older persons and research into its causes, prevention, and treatment. Topics of interest include: o Risk factors, natural history, clinical, and functional features of failure to thrive in various high-risk older subpopulations. Though large scale primary epidemiologic studies are outside the scope of this PA, ancillary studies to existing population studies are appropriate and encouraged. o Primary endocrine, metabolic, cellular and related pathophysiologic mechanisms contributing to failure to thrive in older persons. o Relationship between nutritional deficiencies, or impairments in nutrient disposition or metabolism, as causes or results of the various pathophysiological abnormalities described in "failure to thrive" in older persons. o Interactions and interrelationships among the different components of failure to thrive, e.g. hypocholesterolemia, specific abnormalities in immunologic and inflammatory factors, infection, depression. o Metabolic responses and alterations in nutritional needs of older persons associated with acute conditions that may provoke failure to thrive, e.g., infections, trauma, or surgery. o Factors modulating control of appetite as a cause or consequence of failure to thrive. o Pathophysiologic effects of coexisting chronic diseases and/or comorbid processes of aging contributing to failure to thrive. o The role of psychosocial and cultural factors, (e.g., social supports, social stressors, bereavement, depression, mood and affect, cultural preferences) in failure to thrive syndrome. o Development and use of appropriate animal models for studying failure to thrive in older persons. o Neural interactions with physiological processes underlying failure to thrive syndrome. o Efficacy of interventions in preventing, arresting, or reversing failure to thrive. Applicants may choose to study specific populations and conditions, e.g., post-surgical or trauma patients, infections, or depression. Attention to physiologic factors or comorbid conditions modulating efficacy of interventions in these conditions is particularly encouraged. o Delineation of psychiatric conditions of failure to thrive (including the range of clinically significant affective symptoms) and the elucidation of the interrelationship among psychiatric status, physiological measures, and behavior. For any of the above topics, attention to the heterogeneity and frequent multiple morbidity within the geriatric population is encouraged in the design of research projects. STUDY POPULATIONS It is NIH policy that women and minorities must be included in clinical study populations unless there is a good reason to exclude them. The study design must seek to identify any pertinent gender or minority population differences. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that, as appropriate, applicants for NIH grants, cooperative agreements, and contracts will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the diseases, disorders, or conditions under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males as well as 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 for exception to the policy must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic groups, together with a rationale for its choice. 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 should 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 populations should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH 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 exempt. 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned without review. 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 is inadequate to answer the scientific questions(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 the 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. APPLICATION PROCEDURES Applications are to be submitted on the application form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone 301/496-7441. Applications will be accepted on the standard application receipt dates as indicated in the application kit. The program announcement title and number must be typed on line 2a of the face page. The completed original application and five legible copies must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be reviewed by the NIH Division of Research Grants (DRG). The review criteria are the traditional considerations underlying scientific merit. Applications will be reviewed by standard NIH review procedures in accordance with the usual NIH peer review procedures, based on scientific merit. Following study section review, the applications will be evaluated by the appropriate national advisory council. The review criteria for each mechanism may be obtained from the program contact listed below. AWARD CRITERIA Applications will compete for available funds on the basis of scientific merit with other applications. 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 The opportunity to clarify any issues and questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Pamela Starke-Reed, Ph.D., Geriatrics Program, Suite 3E327 Telephone: (301) 496 6761 Huber Warner, Ph.D., Biology of Aging Program, Suite 2C231 Telephone: (301) 496-6402 Marcia Ory, Ph.D., M.P.H., Behavioral and Social Research Program, Suite 2C234 Telephone: (301) 496-3136 Andrew Monjan, Ph.D., Neuroscience and Neuropsychology of Aging Program, Suite 3C307 Telephone: (301) 496-9350 All are at the NIA with the following address: National Institute on Aging Gateway Building Bethesda, MD 20892 or Rick Martinez, M.D. or Enid Light, Ph.D. Mental Disorders of the Aging Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 7-103 Rockville, MD 20857 Telephone: (301) 443-1185 Direct inquiries regarding fiscal matters to: Barbara Cunningham Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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. .
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