Key Dates

Related Announcements

PA-19-270 - PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-19-272 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of an area of special interest in research to improve methods to assess body composition in infants and young children ages birth through 5 years.

Background

Obesity in children continues to increase and remains a major public health problem with the prevalence among youth ages 2-19 years estimated to be 18%. Racial/ethnic disparities in prevalence remain significant with non- Hispanic Black and Hispanic youth having higher rates of obesity than non-Hispanic White children. Accelerated growth patterns and the development of obesity during infancy and early childhood are associated with a higher risk of overweight or obesity in adolescence and adulthood as well as greater risk for developing various health complications, such as insulin resistance, type 2 diabetes, high blood pressure, abnormal blood lipids, and non-alcoholic fatty liver disease.

The amount of fat mass and its distribution in the body, notably abdominal fat, are strongly associated with the development of cardiometabolic co-morbidities. Yet, due to limitations in available methods, most studies in infants and young children use anthropometric indices of weight for length or weight for stature (BMI) to track growth and characterize obesity. These measures do not accurately reflect adiposity because weight-based measures do not distinguish fat mass from fat-free mass. Furthermore, racial and ethnic minority populations may have differences in both the amount and distribution of body fat that could confer differential health risk even in the absence of elevated BMI. Skinfolds and waist circumference are similarly anthropometric indirect measures of fat mass that can also be technically difficult, limiting accuracy and reproducibility. Among the available methods that can distinguish fat mass from fat-free mass, several factors can limit their accuracy and/or feasibility in this age group including incorrect assumptions about fat free mass hydration (deuterium dilution), the need for highly specific prediction equations (bioimpedance analysis), the need to remain motionless during testing (Magnetic Resonance Imaging and Dual-energy X-ray absorptiometry), or lack of equipment designed for this age range (air-displacement plethysmography).

An NIDDK workshop, Body Composition Measurements from Birth through 5 Years: Challenges, Gaps, and Existing & Emerging Technologies was held in May 2019 to assess current knowledge and provide feedback on gaps and opportunities to accelerate progress in this area of research (https://www.niddk.nih.gov/news/meetings-workshops/2019/body-composition-2019). From this workshop and current literature in the field, it is evident that methods to assess body composition that are accurate, reliable, and feasible during infancy and early childhood are lacking, especially those that can be used to track adiposity longitudinally. Research to more accurately assess body composition and its distribution in infants and young children is needed to improve our ability to 1) accurately characterize infants and children with obesity, 2) identify those at risk for developing high adiposity and adverse health conditions, and 3) assess the impact of obesity prevention and treatment interventions on body composition and health outcomes from infancy to mid-childhood.

Research Objectives:

This Notice invites SBIR and STTR applications that seek to fill technological gaps in assessment of body composition and its distribution in infants and/or young children from birth through 5 years. Research proposing to conduct interventions designed to alter body composition in children or proposing the development of norms for lean body mass and adiposity in young children using existing technologies would not be appropriate for this Notice. Applications proposing to conduct animal research are also not appropriate.

Topics identified as high priority for further development of reproducible technologies include, but are not limited to, the following:

• Development and validation of new technologies and the adaptation of existing modalities to the unique size and behavioral needs of children ages birth through 5 years.
• Development and validation of imaging approaches that are not limited by protocol comprehension, cooperation, movement or body position of the child
• Development and validation of portable or point-of-care technologies, or methods that are quick, simple to administer, affordable, and practical for field use as well as feasible in clinical settings.

National Institute of Biomedical Imaging and Bioengineering (NIBIB):

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies in assessment of body composition and its distribution in infants and/or young children from birth through 5 years. NIBIB scientific program areas that are appropriate for this funding opportunity can be found at NIBIB website (https://www.nibib.nih.gov/research-funding). For additional guidance, potential applicants are encouraged to contact the NIBIB Scientific/Research Contact.

NIBIB and NIDDK will not accept primary assignment of any applications only focusing on validation or assessing effectiveness of existing methods and/or biomarkers through this Notice of Special Interest.

Application and Submission Information

This notice applies to due dates on or after September 5, 2020 and subsequent receipt dates through September 5, 2022.

Submit applications for this initiative using the reissueof the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DK-20-036 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to:

Voula Osganian, M.D., Sc.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-6939
Email:voula.osganian@nih.gov

Qi Duan, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-827-4674
Email: Qi.Duan@nih.gov

Ilana Goldberg, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-402-3565
Email: NIBIB-SBIR@mail.nih.gov