Full Text PA-96-064
 
MENTAL HEALTH RESEARCH IN EATING DISORDERS
 
NIH GUIDE, Volume 25, Number 23, July 12, 1996
 
PA NUMBER:  PA-96-064
 
P.T. 34

Keywords: 
  Emotional/Mental Health 
  0715091 
  Etiology 
  Epidemiology 
  Neuroscience 

 
National Institute of Mental Health
National Institute of Dental Research
National Institute of Diabetes and Digestive and Kidney Diseases
Office of Research on Women's Health
 
PURPOSE
 
The National Institute of Mental Health (NIMH), National Institute of
Dental Research (NIDR), National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) and Office of Research on Women's Health
(ORWH) invite applications for studies relevant to the neuroscience,
epidemiology, etiology, treatment, services research, and prevention
of eating disorders (anorexia nervosa, bulimia nervosa, and binge
eating disorder), and their comorbidity with other medical,
dental/craniofacial, and psychiatric disorders.  The purpose of this
program announcement is to promote additional mental health research
emphasis on the broad array of influences, including gender, on
eating disorders and ingestive behaviors.
 
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,
Mental Health Research in Eating Disorders is related to the priority
area of mental health and mental disorders.  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
 
A variety of funding mechanisms are encouraged within this
announcement, and eligibility and requirements for these funding
mechanisms vary.  Applicants are advised to contact NIMH, NIDR, or
NIDDK program staff listed under INQUIRIES for additional information
and specific application procedures.
 
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 or
local governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for Small Grants (R03),
Education projects (R25), or First Independent Research Support and
Transition (FIRST) (R29) awards,  Racial/ethnic minority individuals
women, and persons with disabilities are encouraged to apply as
principal investigators.
 
MECHANISM OF SUPPORT
 
Applications are requested under the following mechanisms: research
project grant (R01), small grant (R03), and FIRST award (R29).
Applications to NIMH are also requested under the education projects
(R25) mechanism. For additional information concerning Mental Health
Education Projects, see the NIH Guide, Vol. 25, No. 14 (May 3, 1996).
For research in method development, the small grant (R03) is a
particularly appropriate mechanism; investigators may also choose to
include method development as one component within research project
grant (R01) applications.
 
Support may be requested for a period of up to five years, except for
small grants (R03), which are limited to two years.  FIRST awards
must be requested for five years. Annual noncompeting awards will be
made subject to continued availability of funds and progress
achieved.  Because Education Projects, and FIRST awards have special
eligibility requirements, dollar ceilings, application formats, and
review criteria, applicants are strongly encouraged to consult with
program staff (listed under INQUIRIES, below) and to obtain the
appropriate additional announcements for those grant mechanisms.
 
An applicant planning to submit a new (Type 1) investigator-
initiated grant application requesting $500,000 or more in direct
costs for any year is advised that he or she must contact Institute
program staff before submitting the application, i.e, as plans for
the study are being developed.  Furthermore, the applicant must
obtain agreement from the staff that the Institute will accept the
application for consideration for award.  Finally, the applicant must
identify, in the cover letter that is sent with the application, the
staff member and Institute who agreed to accept assignment of the
application.  Any application subject to this policy that does not
contain the required information in the cover letter sent with the
application will be returned to the applicant without review.  For
additional information concerning large grant applications, see the
NIH Guide, Vol. 25, No. 14 (May 3, 1996).
 
RESEARCH OBJECTIVES
 
Summary
 
Mental health disorders encompassing eating disorders and ingestive
behaviors are an area of increasing public concern in the United
States.  Anorexia nervosa is a syndrome characterized by body weight
severely below normal, body- image disturbance, and an intense fear
of, and resistance to, weight gain.  Bulimia nervosa is a syndrome
characterized by repeated episodes of binge-eating followed by a
variety of purging or other compensatory behaviors such as vomiting,
laxative or diuretic use, excessive exercise, and/or fasting.  Body
weight, however, may remain in the normal range.  Binge eating
disorder is a recently identified syndrome in which there are
repeated episodes of binge eating without subsequent regular purging
behavior, typically resulting in body weight above normal limits.
 
It is estimated that anorexia affects from .5 to 1 percent of teenage
and young women, and bulimia from one to three percent.  Women are 8
to 10 times more likely to suffer from anorexia or bulimia than men.
Estimates of binge eating disorder range from about one to four
percent of the population with women being about 1.5 times more
likely to have this disorder than men.  It has been estimated, on
average, that 30 percent of enrollees in weight reduction programs
suffer from binge eating disorder.
 
Eating disorders, which may become chronic, frequently have serious
psychological and medical consequences.  Virtually all bodily systems
are affected by starvation, and cardiac, gastrointestinal, and
electrolyte disturbances are most common. Clinical depression and
anxiety disorders commonly co-occur with eating disorders.  Morbidity
and mortality in anorexia nervosa are among the highest of any mental
disorder. It has been estimated that some 10 percent of patients with
anorexia nervosa will die from complications of the disorder.
 
Eating disorders have a high degree of comorbidity with other
psychiatric disorders, as well as with some medical disorders.  In
anorexia nervosa, affective disorders are most common, followed by
anxiety disorders with obsessive compulsive disorder most prevalent.
Among patients suffering from bulimia nervosa, high rates of
affective disorder and anxiety disorders have been reported, as well
as personality disorders and substance abuse.  Binge eating disorder
is associated with a higher degree of psychiatric comorbidity than is
found in obese people who do not binge eat.  Also, a "failure to
thrive" syndrome, characterized by malnutrition, depression, and
physical illness has been described in geriatric populations.
Despite their high degree of comorbidity, eating disorders are
distinct disorders; they do not transmute into other illnesses.
 
Research Scope and Goals
 
New research on the psychosocial and biological factors underlying
eating disorders is needed to clarify issues of etiology and
treatment.  While a broad array of epidemiological, familial,
biological, and treatment studies have identified promising leads,
major questions in these areas remain unanswered.
 
This program announcement emphasizes the need for research on eating
disorders at all levels from fundamental studies of brain and
behavior which identify basic  mechanisms, to examinations of risk
factors, to epidemiological and clinical investigations which help to
successfully diagnose and treat the disorders.  The overall goal is
to establish a clearer understanding of the etiology, and treatment
of these complex disorders, and ultimately, to prevent them.
 
Eating Disorders research applications are welcome in the following
broad areas:
 
o  Neuroscience and Behavioral Science
 
o  Epidemiology, including Comorbidity with Other Medical and
Psychiatric Disorders and Genetic Studies
 
o  Behavioral Medicine
 
o  Treatment Studies
 
o  Services Research (NIMH only)
 
1. Neuroscience and Behavioral Science
 
The regulation of energy and nutrient balance involves multiple
complex systems in the brain and body.  Integrative and
interdisciplinary approaches will help us understand the genetic,
immune, endocrine, neural, and behavioral determinants of energy
balance, storage and body weight. Neural circuitry and
neurophysiological research in animal models of ingestion have now
advanced to where the important role of genetic and other molecular
factors are rapidly being discovered.  There is a pressing need to
apply this knowledge to non-human primates and humans, and for the
basic research approaches to be integrated with the development of
new drugs in the clinical setting. Research in the following areas is
encouraged:
 
o  Individual, family and community studies to clarify the
contributions of personality, attitudes, and social dynamics to
patterns of feeding, nutrition and body weight.
 
o  Basic studies of biochemical, neural, and psychological mechanisms
of eating behavior, including taste and satiety.
 
o  The role of cognition and perception in eating behavior and eating
disorders, and their interaction with social influences on the
development of the body image.
 
o  Development of animal models of diagnostic or biological features
of anorexia nervosa and bulimia nervosa.
 
o  Animal studies of metabolic efficiency, motivation, and behavior
following changes in nutritive intake produced by peripheral,
central, or environmental manipulations.
 
o  The influence of sex steroid hormones on changes in feeding
patterns, their relation to gender differences in behavior and brain
activity.
 
o  The interaction of feeding patterns with other major homeostatic
systems including reproductive-cycle, circadian rhythms, sleep and
wakefulness, and the regulation of stress.
 
o  The application of new molecular methods such as gene knockout
technologies to specify the role of brain peptides, hormones, and
cytokines, in disordered patterns of eating; and to identify genetic
vulnerabilities and potential pharmacological interventions for
weight gain or loss.
 
o Studies of peripheral autonomic function in the development and
maintenance of appetitive dysfunction or purging behaviors
 
2.  Epidemiology and Comorbidity
 
Research is needed to provide more accurate epidemiological data on
anorexia nervosa and bulimia nervosa.  Research in the following
areas is encouraged:
 
o  Community-based epidemiologic surveys to identify prevalence and
incidence of eating disorders and their comorbidity with medical
(including diabetes mellitus), psychiatric, and substance abuse
disorders.
 
o  Prospective epidemiological studies to identify biological
(including genetic), psychological, and social factors contributing
to the development and maintenance of eating disorders and their
impact on the onset and course of these illnesses in both women and
men.
 
o  Epidemiological study of high-risk populations, such as adolescent
dieters and athletes, and children of eating- disordered parents.
 
o  Studies evaluating the epidemiology, clinical course, and response
to treatment of subclasses of individuals currently identified as
Eating Disorders Not Otherwise Specified (EDNOS)
 
o  Longitudinal studies for the early identification of infants and
children at risk for developing eating disorders as well as follow up
studies of individuals with eating disorders to identify the
long-term course and outcome of these disorders and the impact of
various types of treatment.
 
o  Epidemiological studies of high-risk families to examine the
contribution and relationship of genetic traits, familial dynamics,
individual personalities, and incidence of other mental disorders.
 
o  Studies evaluating understudied populations with eating disorders,
including men and racial and ethnic minorities.
 
o  Refining dental indicators for early identification and referral.
(Particular patterns of tooth erosion are, for example,
characteristically seen in bulimia, although many dental
practitioners may not be aware of this).
 
o  Effects of malnutrition from eating disorders on dental/oral
conditions (e.g., periodontal diseases, aphthous ulcers, caries).
 
3.  Behavioral Medicine
 
Little is known about the prevention of eating disorders and studies
are needed that increase understanding of the behavioral aspects of
eating disorders.  Such studies include the:
 
o  Examination of the link between behavioral and physiological
processes underlying normal and abnormal eating.
 
o  Characterizations of normal and abnormal eating patterns under
various cultural and occupational conditions, and as influenced by
gender-specific attitudes and behaviors.
 
o  Study of comorbidity of eating disorders with physical illness.
 
o  Health promotion campaigns through dental offices to alert
families/patients to dental consequences
 
4.  Treatment Studies
 
Treatment studies have suggested the efficacy of specific
pharmacological and psychosocial interventions for some patients with
eating disorders.  While there is general agreement that a
multidimensional treatment approach, including individual, group
and/or family psychotherapy, psychopharmacotherapy, and behavioral
interventions is necessary to treat most patients with eating
disorders, few controlled clinical trials have been undertaken to
evaluate these treatment modalities.  Integrated treatment studies
are particularly important to determine the efficacy of combined
psychosocial and pharmacologic therapies and the active components of
each of these treatments.
 
Because of the serious physical health and mental health consequences
of anorexia nervosa, bulimia nervosa, and binge-eating disorder,
treatments for these disorders and intervention strategies to prevent
their recurrence need to be developed and tested.  Such treatments
need to be studied across various stages of the life cycle and of the
disorder. With the growing database of efficacious short-term
treatments for some eating disordered patients, emphasis should be
placed on longer-term trials aimed at maintaining or building upon
the improvement obtained during acute treatment.  Treatment studies
should acknowledge the chronic nature of most eating disorders and
assess outcome accordingly, including, but not limited to, a studied
intervention's success and safety in maintaining healthy eating and
activity habits, preventing relapse, and ameliorating other comorbid
mental or physical health disorders.  Controlled treatment studies
are needed to:
 
o  Assess the efficacy of psychosocial treatments for eating
disorders in a variety of treatment settings, to identify the active
components of standardized individual, group, and family/couples
therapies (using, for example, manualized cognitive-behavioral or
behavioral, interpersonal, or psychodynamic approaches),  and to
explore new therapeutic techniques.
 
o  Determine the efficacy of pharmacological treatments for eating
disorders.  As with psychosocial interventions, this would include
both short-term trials and longer-term continuation medication
studies aimed at maintaining or building upon the gains of acute
treatment, e.g. weight restoration in anorexia nervosa.
 
o  Determine the effects and contributions of integrated combination
treatments, including the range of psychotherapies noted above and
concurrent medication.
 
o  Aid in predicting and preventing relapse, long-term follow up
studies to determine which factors contribute to maintenance of
improvement/remission and to relapse or recurrence.
 
o  Evaluate the optimal interdigitation of treatment of eating
disorders per se with the preceding, concurrent, or subsequent
treatment of comorbid physical health or mental disorders.  Examples
of commonly occurring comorbidities include the medical consequences
of starvation in anorexia nervosa and obesity in binge-eating
disorder.
 
o  Determine the mechanisms involved in abnormal weight gain or loss
side effects of commonly used treatments for major mental disorders.
 
o  Encourage dental participation in multi-disciplinary treatment for
the eating disorder
 
o  Develop and test methods to reduce damage to teeth resulting from
these disorders.
 
5.  Services Research (NIMH only)
 
Previous research suggests that while efficacious treatments exist
for some forms of eating disorders, little is known about their
effectiveness -- how they work in real world settings.  Furthermore,
little is known about improving the identification of affected
individuals, including the development of valid screening tools and
effective programs targeting high risk populations; access and
pathways to treatment; and the cost-effectiveness of various forms of
treatment.  The following are examples of research issues that are
covered under this announcement:
 
o  Assessment of effectiveness of proven treatments and
interventions, including long-term follow-up and measurement of
multiple outcome domains.
 
o  Development of valid, reliable screening instruments.
 
o  Studies of prevention interventions targeting care-givers of the
at-risk population (i.e., teachers, coaches, parents)
 
o  Studies of screening and education programs to promote earlier
identification and treatment of individuals with eating disorders as
well as research on the implementation and cost-effectiveness of such
programs targeting high risk populations.
 
o  Studies of the cost-effectiveness of various treatments including
treatment combinations.
 
o  Studies of mechanisms for the effective transmission of knowledge
and skills in the provision of psychotherapeutic modalities with
established efficacy in the treatment of eating disorders to mental
health practitioners and primary care providers.
 
o  Long-term follow-up studies to assess maintenance and relapse
prevention strategies.
 
o  Assessment of treatment effectiveness in special populations,
including racial/ethnic minorities, rural populations and difference
age groups, in combination with gender-specific analysis.
 
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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
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 reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also 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 the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Please note that R25
applications are received only once a year, on October 1. Application
kits are available at most institutional offices of sponsored
research and may be obtained from the Office of Extramural Outreach &
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 710-0267;
Email [email protected].  The title and number of the
program announcement must be typed in Section 2 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
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight mail 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 and undergo a process in which only
those applications 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.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
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 approved
applications.  The quality of the proposed project (as determined by
peer review), the availability of funds, and program priority will
all be considered in making funding decisions.
 
INQUIRIES
 
Inquiries are encouraged.  Institute staff welcome the
opportunity to clarify any issues or questions from
potential applicants.
 
Please direct inquiries regarding programmatic issues to:
 
Harold Goldstein, Ph.D.
Clinical Director, Eating Disorders Program
National Institute of Mental Health
Parklawn Building, Room 10-85
Rockville, MD  20857
Telephone:  (301) 443-4140
FAX:  (301) 443-4045
Email:  [email protected]
 
Susan Z. Yanovski, M.D.
Division of Digestive Disease and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AN-18
Bethesda, MD  20892-660
Telephone:  (301) 594-8882
FAX: (301) 480-8300
Email:  [email protected]
 
Dr. Patricia S. Bryant
Behavior, Pain, Oral Function, and Epidemiology Program
National Institute of Dental Research
Building 45, Room 4AN-24K
Bethesda, MD  20892
Telephone:  (301) 594-2095
FAX:  (301) 480-8318
Email:  [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  [email protected]
 
Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AS-49H
Bethesda MD  20892-6600
Telephone:  (301) 594-8846
Email:  [email protected]
 
Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX: (301) 480-8301
Email:  [email protected]
 
The National Institute of Nursing Research (NINR) is not a co-sponsor
of this program announcement, but it is interested in related
research on eating disorders.  For information concerning related
research interests, contact:
 
J. Taylor Harden, Ph.D., RN
Division of Extramural Programs
National Institute of Nursing Research
Natcher Building 45, Room 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5976
FAX:  (301) 480-8260
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.242 (NIMH), 93.121 (NIDR) and 93.848 (NIDDK).
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 66, and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.  Awards
will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement (April 1, 1994).
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the nonuse 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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