Notice Number: NOT-DK-19-007

Key Dates
Release Date: January 7, 2019

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Behavioral and Social Sciences Research (OBSSR)

Purpose

The purpose of this Notice is to inform potential applicants to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD), and Office of Behavioral and Social Sciences Research (OBSSR) of an area of special interest in understanding factors in infancy and early childhood (birth to 24 months) that influence the development of obesity.

Background:

Overweight and obesity in children and adolescents has increased dramatically over the past three decades. In addition, there are significant disparities in obesity prevalence, with greater increases in prevalence in Hispanic boys and non-Hispanic Black girls, compared with non-Hispanic White boys and girls.

Youth who are obese face myriad short-term and longer-term health consequences including type 2 diabetes, elevated risk for cardiovascular disease, orthopedic conditions, non-alcoholic fatty liver disease, depression, and other psychosocial problems. Obesity during childhood also contributes to disabilities as well as increased health care costs. Unfortunately, once established, obesity and its comorbid medical conditions are difficult to treat and usually persist throughout adulthood. Thus, preventing the development of overweight and obesity as early as possible is critical for efforts to improve public health and to reduce the health care costs associated with obesity-related diseases now and in the future.

Some evidence suggests that infancy and early childhood (birth to 24 months) may be a critical period in the development of overweight/obesity. Moreover, risk for the development of overweight and obesity during this period appears to be increased in children from racial and ethnic minority and low socioeconomic status populations. Factors that contribute to excessive weight gain during infancy and early childhood are diverse and likely bi-directional between the caregiver/family, environment, and young child.

An NIH Workshop on the Prevention of Obesity in Infancy and Early Childhood was held in November 2013 to assess current knowledge and to determine both gaps and opportunities to accelerate progress in this area of research. The purpose was to provide the scientific background to inform the research needed to prevent excessive weight gain in early life with a goal of increasing the number of children who enter school at a healthy weight. Although some interventional clinical trials to prevent obesity or excessive weight gain during infancy and early childhood are ongoing, many knowledge gaps need to be filled in order to better develop successful interventions in this age group. These gaps include understanding factors that contribute to high risk for excessive weight gain during infancy and early childhood and which also may help explain differential response to treatment. Additionally, research is needed to develop and/or validate assessment methodologies that can be used to efficiently and accurately evaluate behavioral, metabolic, and other factors that may influence weight gain trajectories.

Research Objectives:

This Notice invites research applications that seek to fill methodological research gaps and/or characterize infant and early childhood phenotypes that may increase or mitigate risk for obesity. Studies should focus on topics relevant to research in children from birth to 24 months, although any proposed follow-up assessments, if applicable, may continue past this period. Studies that focus on typically as well as atypically developing children (e.g., those with intellectual, developmental, or physical disabilities) are appropriate for this announcement. Applications should seek to fill research gaps and involve expertise across multiple disciplines as relevant to the proposed research question. Applications proposing to conduct randomized interventional clinical trials to prevent or treat obesity are not appropriate for this funding opportunity. Applications proposing to conduct animal research are also inappropriate for this funding opportunity.

Topics identified as high priority for further research include, but are not limited to, the following:

• Behavioral and physiological phenotypes, such as individual differences in appetite, food preference, temperament, self-regulation and other factors related to excessive weight gain that may predict obesity development and/or treatment response
• Infant and early childhood feeding practices, sleep, physical activity or sedentary behaviors that may influence weight gain and risk for obesity.
• Patterns of weight gain and growth trajectories during infancy and early childhood that are associated with risk for development of obesity
• Family and caregiver aspects that may influence weight gain, such as parenting style, responsiveness to infant/child needs, stress, and other psychosocial characteristics
• Impact of food type, composition, or introduction during infancy on weight gain trajectory (e.g. high vs. low protein formula, fat composition of breast milk, timing and sequence or introduction of solid foods)
• Emerging obesity risk factors, including the hormonal milieu, microbiome, and epigenetic modifications.
• Development and/or validation of methods to assess body composition, dietary intake/composition, and physical activity/sedentary behaviors as well as sleep duration and quality in infants and young children.
• Development and/or validation of methods to assess infant/child behavioral factors that contribute to weight gain trajectory and obesity risk, such as appetite, temperament, learning, and other attributes.
• Development and/or validation of methods to assess behavioral factors in caregivers that may influence the child's weight gain trajectory and obesity risk.

Application and Submission Information:

Applications for this Notice must submit an application through NIH Parent Announcement PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) or PA-18-330: Investigator-Initiated Clinical Trials Targeting Diseases within the Mission of NIDDK (R01-Clinical Trial Required). The latter should be used for studies that incorporate mechanistic trials.

All instructions for the Parent Announcement must be followed.

Submissions should indicate that they are in response to NOT-DK-19-007 in Field 4.b on the SF 424 form.

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

Layla Esposito, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6888
Email: espositl@mail.nih.gov

Derrick Tabor, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8950
Email: Derrick.Tabor@nih.gov

Deborah Young-Hyman, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-0724
Email: younghyd@od.nih.gov