Notice Number: NOT-HL-19-695

Key Dates
Release Date: May 21, 2019

PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-19-055: NIH Research Project Grant (Parent R01 Clinical Trial Required)
NOT-HL-19-690: NHLBI Limitations on Clinical Trial Applications Submitted to the NIH Parent (R01 Clinical Trial Required) Funding Opportunity Announcement (FOA)

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform potential applicants to the National Heart, Lung, and Blood Institute (NHLBI) 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 with obesity rates highest among Latino and African American children.

Youth who have obesity face myriad short-term and long-term health consequences including elevated risk for cardiovascular disease, type 2 diabetes, 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.

Evidence indicates that infancy and childhood (birth to 24 months) are critical periods in the development of overweight/obesity, particularly in children from racial and ethnic minority and low socioeconomic status populations. The behavioral, biological, psychosocial, and environmental factors contributing to early obesity onset and trajectory need to be delineated in order to identify children most at risk for obesity, and to optimize prevention and treatment strategies beginning at an early age.

An NIH Workshop on the Prevention of Obesity in Infancy and Early Childhood was convened in November 2013 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 that explain differential response to treatment. Additionally, research is needed to develop and/or validate assessment methodologies to efficiently and accurately evaluate behavioral, metabolic, and other factors that influence weight gain trajectories.

Research Objectives

NHLBI encourages research applications that aim to delineate behavioral, biological, psychosocial, and/or environmental factors and their potential interactions that increase or mitigate the risk of obesity from birth to 24 months. Bi-directional influences between the child, caregivers/parents, and environment are of interest. Research to address methodological research gaps in the study of obesity and obesity-related factors in infants and young children is strongly encouraged. Proposed studies should focus on topics relevant to children from birth to 24 months, although 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.

NHLBI is interested in supporting mechanistic trials related to the development of obesity in children aged 0-24 months under this funding opportunity. Multi-disciplinary research that incorporates a systems science perspective and targets at risk groups (e.g., low-income individuals, ethnic/racial minorities) is encouraged. Research topics include, but are not limited, to the following:

• Investigate patterns of weight gain and growth trajectories during infancy and early childhood that are associated with risk of development of obesity and cardiovascular disease risk factors.
• Examine mechanisms by which early weight gain may be related to blood pressure during infancy and early childhood.
• Elucidate the contribution of sleep deficiency (irregular sleep-wake patterns, insufficient sleep time, and poor sleep quality) during 0-24 months in infants and/or parents to the risk of obesity and obesity related pathophysiology in infants/children.
• Assess the relationship between parental cardiovascular risk and obesity and cardiovascular risk in infancy and early childhood.
• Examine the prevalence and impact of obesity, cardiovascular risk factors and non-cardiac morbidities in children with congenital heart disease.
• Examine infant and early childhood feeding practices, sleep, physical activity or sedentary behaviors that may influence weight gain and risk for obesity.
• Investigate emerging obesity risk factors, including the hormonal milieu, microbiome, and epigenetic modifications in infancy and early childhood.
• Develop and/or validate methods to assess body composition, dietary intake/ composition, physical activity/sedentary behaviors, and sleep duration/quality/timing in infancy and early childhood.
• Assess family and caregiver aspects that may influence weight gain, such as parenting style, responsiveness to infant/child needs, stress, and other psychosocial characteristics.
• Examine 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 in infancy and early childhood.
• Assess the 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).
• Develop and/or validate methods to assess infant/child behavioral factors that contribute to weight gain trajectory and obesity risk, such as appetite, temperament, learning, and other attributes.
• Assess how environmental factors such as food insecurity and media exposure (e.g., television) may exert social influence to shape eating behavior during infancy and early childhood.
• Examine the relationship between respiratory disease/disorders (e.g., asthma, sleep apnea) in the etiology and trajectory of obesity in infancy and early childhood.
• Examine the role of the immune system in the development of obesity in infancy and early childhood.

Applications proposing to conduct animal research are not appropriate for this funding opportunity.

Application and Submission Information:

This notice applies to due dates on or after July 6, 2019.The following funding opportunity announcements (FOAs) or their reissued equivalents must be used for submissions for this initiative:

• PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-055 NIH Research Project Grant (Parent R01 Clinical Trial Required)*

All instructions for the selected FOA must be followed. *Note that NHLBI has limited the type of clinical trial that will be accepted under PA-19-055 and applicants submitting to PA-19-055 must consult NOT-HL-19-690 "NHLBI Limitations on Clinical Trial Applications submitted to the NIH Parent (R01 Clinical Trial Required) Funding Opportunity Announcement (FOA)."

For funding consideration, applicants must include NOT-HL-19-695 in the Agency Routing Identifier field (Box 4.b) of the SF 424 (R&R) Form. Applications without this information in Box 4.b will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NHLBI program officer listed on this NOSI well in advance of the grant receipt date.

Inquiries

Please direct all inquiries to:

Division of Cardiovascular Sciences
Charlotte Pratt, Ph.D.
National Heart, Lung, and Blood Institute
Email: prattc@nhlbi.nih.gov
Telephone: 301 435-0382

Division of Lung Diseases

Aaron Laposky, Ph.D.
National Heart, Lung, and Blood Institute
Email: [email protected]
Telephone: 301 827-7837

Division of Blood Diseases and Resources
Iman K. Martin, Ph.D., M.P.H, M.Sc.
National Heart, Lung, and Blood Institute
Email: [email protected]
Telephone: 301 827-5814