REQUEST FOR ADDITIONAL FIELD SITES TO PARTICIPATE IN A SCHOOL-BASED 
TRIAL OF PREVENTION OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS

RELEASE DATE:  July 22, 2003

NOTICE: NOT-DK-03-006

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)

The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) seeks additional field sites to participate in a multi-center 
school-based trial to prevent the development of type 2 diabetes in 
middle school children. Type 2 diabetes has been traditionally viewed 
as a disease of adults; however, recent epidemiologic data reveal an 
increasing number of cases of type 2 diabetes in the pediatric 
population, especially among adolescents and in certain minority 
populations. The increase of type 2 diabetes in youth is presumed to be 
a consequence of widespread obesity and decreased physical activity.

Controlled, clinical trials in adults have demonstrated that lifestyle 
interventions can be used to prevent the development of type 2 diabetes 
in high risk adults. These interventions may not be directly applicable 
to the high risk pediatric population, which is predominantly in the 
pre-adolescent or adolescent age range. The adolescent period presents 
special challenges when attempting to promote behavior or lifestyle 
changes. In addition, while lifestyle interventions have worked in the 
context of a highly controlled clinical trial directed at individuals, 
more cost-effective population-based primary prevention programs are 
needed to decrease risk factors for type 2 diabetes and lower the 
incidence of the disorder. Children represent a unique "target" 
population, which may be amenable to population-based public health 
interventions delivered in the school setting.

NIDDK is sponsoring a multi-site primary prevention trial to reduce 
risk factors for type 2 diabetes in middle-school aged children. Middle 
schools were chosen as a target for several reasons. Children in the 
6th-8th grades (middle school) are generally 11-14 years old and in early 
adolescence.  This is a time when obesity markedly increases.  This is 
also a time when children assume more responsibility for their own diet 
and physical activity patterns.  By developing a comprehensive 
intervention to alter the diet and physical activity practices of 
middle school children, obesity could be prevented or lessened.  By 
preventing or lessening obesity, insulin resistance should be 
ameliorated and glucose intolerance (prediabetes) and diabetes 
prevented.  

Planning for this trial has begun under a cooperative agreement, 
Studies to Treat or Prevent PediatricType 2 Diabetes (STOPP-T2D), 
funded under RFAs DK-01-010
(https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-010.html)
and DK-01-011 
(https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-011.html) 
which invited applications for field sites and a Coordinating Center. 
The cooperative agreement is funded for 7 years, anticipating three 
phases: 1) planning, 2) recruitment and study, and 3) analysis. 
Currently, a Steering Committee, composed of the Principal 
Investigators from the field sites, the Principal Investigator of the 
Coordinating Center, an NIDDK representative, and several outside 
experts, has begun protocol development for this trial. However, 
additional field sites are needed to assure adequate power, as well as 
geographic and racial/ethnic diversity. It is the intent of the NIDDK 
to add new field sites in a timely manner, so that these new sites can 
participate in the planning process for the trial. Awards to the 
additional field centers will be made through subcontracts to the 
Coordinating Center. The Principal Investigators from the new sites 
will serve on the Steering Committee and be full partners in the 
development of the trial. Funding is available for travel of the 
principal investigator and other key personnel to planning meetings, as 
well as for effort commensurate with the level of participation in 
protocol development. Once the trial begins, the subcontracts will 
provide funds to each center to support personnel, supplies, equipment, 
communication, travel and school/subject costs associated with the 
study. The award of each subcontract will depend on the requirements of 
the protocol ultimately designed by the Steering Committee. It is 
anticipated that several pilot studies will be conducted in the 2004-
2005 school year and that the full trial will begin in August/September 
2005. 

Requests to participate may be submitted by institutions in the United 
States. This geographic constraint is necessary because of the need for 
close communication and meetings among members of the Steering 
Committee and because of the need to work within the school system. 
Requests should be submitted on a PHS 398 
(https://grants.nih.gov/grants/funding/phs398/phs398.html). Each 
request should have a face page, abstract, biographical sketches for 
the principal investigator and other proposed key personnel, 
description of resources including the number, size and demographic 
composition of middle schools to which the investigators will have 
access, and a research plan. The biosketch should include a description 
of all active research support and a description of recently completed 
projects. A budget is not needed, since the budget will be determined 
by the design of the protocol by the Steering Committee. The research 
plan should not exceed 5 pages and should include: 1) a brief proposal 
for the design of the trial, with a discussion of the rationale for 
selecting this trial design, focusing on the choice of interventions 
and the choice of outcome measures; 2) a detailed description of the 
demographics of the proposed trial population at the site, and 3) a 
description of the Principal Investigator's experience in school-based 
interventions, and in multi-center or large clinical trials. The 
investigator should discuss all trials in which he/she played a 
significant role, and include an explanation of that role, as well as a 
description of the numbers (or per cent) of eligible subjects 
successfully recruited to those trials. It is anticipated that each 
site will develop a team with multi-disciplinary expertise. The PI and 
key personnel must have experience in conducting school-based 
interventions, as well as expertise in diabetes and/or obesity and 
related metabolic disorders. Requesters must also document their 
willingness to participate on the Steering Committee and appropriate 
subcommittees, work cooperatively with the other members of the 
Steering Committee, and follow the common protocols established 
cooperatively by the Steering Committee. Details regarding the "Terms 
and Conditions" of this cooperative agreements can be found in the 
original RFA.

Request (2 copies) should be submitted no later than August 27, 2003 
to:

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 699, MSC 5460
Bethesda, MD 20892-5460
(for courier service, use zip code 20817)
Telephone: (301) 594-0021
FAX: (301) 480-3503
E-mail: linderb@extra.niddk.nih.gov

All inquiries should be directed to Dr. Linder.

Requests will be evaluated  by a panel convened by the Coordinating 
Center (the George Washington University), according to the following 
criteria:

o documented ability of the potential site to recruit and retain 
schools and subjects for the trial

o qualifications of the principal investigator and proposed key 
personnel as documented by their biosketches an the proposed research 
plan

o contribution of the potential site to geographic and racial/ethnic 
diversity within the study population

o completeness of the request

It is anticipated that up to four additional sites will be supported.

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