Expired PA-13-154: Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R21)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Heart, Lung, and Blood Institute (NHLBI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Office of Behavioral and Social Sciences Research (OBSSR)
Funding Opportunity Title	Home and Family Based Approaches for the Prevention or Management of Overweight or Obesity in Early Childhood (R21)
Activity Code	R21 Research Project Grant
Announcement Type	Reissue of PA-10-128
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-13-154
Companion Funding Opportunity	PA-13-153, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847, 93.837, 93.865
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites exploratory pilot/feasibility study and small clinical trial (R21) applications from institutions/organizations that propose to test novel home or family based interventions for the prevention or management of overweight in infancy and early childhood. Tested interventions can use behavioral (including dietary and physical activity), environmental, or other relevant approaches. Applications should focus on infants and young children (to age 6 years) and emphasize the role of home environment and the influence of family/extended family members and parents (including guardians/substantial care-providers) within the child’s home environment. The direct goal of this initiative is to fund research that will advance knowledge for innovative approaches to the prevention or management of overweight in children less than 6 years of age, with potential for future research clinical trial applications either in the home or linked to a community setting. Research should consider the role of families in the initiation, support, and reinforcement of fundamental food and beverage consumption, physical activity practices, and sedentary behaviors. In addition it is of interest to elucidate various underlying behavioral determinants that are crucial to initiate or sustain changes in behaviors that impact energy balance. Research designs may include linkages with other settings (e.g., daycare, pre-school, or other community venues) or other care providers (e.g., health care providers or teachers) but must include infants or children less than age 6 years as the primary study participant along with parents, and/or other family members residing with the child. The overarching goal is to identify interventions that influence parent and child behaviors that contribute to inappropriate weight gain, and thereby improve subsequent health status in childhood, adolescence, and adulthood for which overweight is a known risk factor.

Key Dates

Posted Date	March 22, 2013
Open Date (Earliest Submission Date)	May 16, 2013
Letter of Intent Due Date(s)	Not Applicable.
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	May 8, 2016
Due Dates for E.O. 12372	Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

This FOA requests innovative applications for exploratory pilot/feasibility study and small clinical trial (R21) applications to test novel approaches for the prevention or management of overweight in infants and children (up to 6 years of age at the time of enrollment) in the context of the home environment, including parental/family involvement. Prevention and management are generally guided by levels of age-appropriate weight status based on the 2000 CDC weight-for-length or BMI-for-age growth charts for boys or girls. Primary prevention is the prevention of inappropriate weight gain in children currently at a healthy weight (BMI or weight-for-length below the eighty-fifth percentile). Secondary prevention is the prevention of inappropriate weight gain in youths currently at risk of overweight (BMI greater than or equal to the eighty-fifth percentile to less than the ninety-fifth percentile). Tertiary prevention in children already overweight (BMI greater than or equal to the ninety-fifth percentile) includes the prevention of further weight gain (i.e., weight maintenance) or the prevention of weight regain among those who have lost weight. Secondary and tertiary prevention are consistent with interventions for the management of overweight. Behavioral intervention approaches that include weight loss in overweight children are considered a part of overweight management and therefore, would be appropriate for this FOA. An Expert Committee has recommended that for primary care practice, in general weight maintenance should be the goal for children ages 2-5 years unless the BMI is greater than 21 kg/m2, in which case weight loss of up to 1 lb/mo may be acceptable; weight goals to improve BMI percentile in children less than 2 years of age were indicated as not applicable (Barlow, 2007). Intervention strategies for prevention or management must be assessed by the child’s weight status as the primary outcome measure, based on the 2000 CDC BMI-for-age or weight-for-length growth charts for boys and girls (percentiles or corresponding z-scores). For this FOA, the home or primary physical residence of the child is the target site for intervention research that focuses on the role and mechanism of the parents, family, and/or the home environment in the initiation, support, and reinforcement of fundamental food and beverage consumption, physical activity practices, and sedentary behaviors, or other behavioral determinants associated with these practices. However, the research intervention (e.g. delivery of information) might occur elsewhere. Parents may be the biological or adoptive parent(s), legal guardian(s), or persons otherwise acting in the role as primary caregiver(s) of the child.

Background Information

The most recent nationally representative survey data for the years 2003-2006 estimate that 12.4% of all children ages 2 through 5 years residing in the United States are overweight (BMI greater than or equal to 95th percentile of the 2000 CDC BMI growth charts) and an additional 16% are at risk of overweight (BMI 85th to less than the 95th percentile). Therefore, approximately one-fourth of all toddler and pre-school children in the United States are estimated to be overweight or at risk of overweight (Ogden et al., 2008). Racial/ethnic disparities have been reported from a nationally representative sample of US children 4 years of age with the highest prevalence among American Indian/Native Alaskan pre-school children for whom obesity is twice as common as in non-Hispanic white or Asian children with an intermediate prevalence among Hispanic and non-Hispanic black children (Anderson and Whitaker, 2009). Harnack et al. (2009) reported a low awareness among parents of overweight status of their pre-school children, concluding this is concerning because parents of overweight children who do not recognize their child’s weight status may be unlikely to engage in obesity prevention efforts. Approximately one-third of children ages 6-11 years (33.3%) and adolescents ages 12-19 years (34.1%) are either at risk of overweight or are overweight. It has been known for some time that weight status tends to track across childhood. By the age of 8 years, most children are in the BMI percentile channel that they will follow until the end of growth in late adolescence (Rolland-Cachera et al., 1988). Taveras et al. (2009) reported that whereas weight-for-length (WFL) at birth was only minimally associated with subsequent overweight, rapid gains in WFL in the first 6 months of life were associated with sharply increased risk of later obesity, suggesting that early interventions to prevent rapid increase in weight status in the first months of life may help reduce children’s risk of obesity later in childhood. In another study, children who were overweight at age 13 years had gained more weight by the age of 2 or 3 years than their normal-weight peers (Lagstrom et al., 2008). Others have shown that BMI tracks over time from childhood through adolescence and into adulthood (Guo et al., 1994; Guo et al., 2002). A prospective study from Australia reported that being overweight at 5 years was associated with BMI and overweight status of young adults at age 21 years (Mamun et al., 2009). The importance of the tracking phenomenon for overweight lies in the well-established knowledge that increased body weight in adulthood is highly associated with increased health risk. A study from Israel (Shibli et al., 2008) indicated evidence of increased health risk in overweight infants and toddlers (less than or equal to age 2 years; weight-for-length greater than or equal to 95th percentile). BMI has been reported to be the strongest childhood predictor of adult metabolic syndrome (Burns et al., 2009). An imbalance between excess dietary energy intake and inadequate energy expenditure are ultimately the determinants of overweight status. At young ages, increases in prevalence of overweight may be influenced by a shift in eating patterns towards larger portion size of energy-dense foods (Lioret et al., 2009). Data from the Feeding Infants and Toddlers Study (FITS) (January 2006 supplement J Am Diet Assoc) indicate that parents may be responsible for feeding patterns and eating habits introduced very early in life that may last a lifetime. Patterns of physical activity and physical inactivity may begin at early ages in the home environment. When combined with a diet of highly energy dense foods, this pattern of inactivity may help explain the increasing prevalence of overweight among young children. In early childhood the home environment may be crucial in establishing the framework for reinforcement of knowledge or practices consistent with energy balance. There is evidence that children who remain home during the preschool years with their parents are less likely to be obese than children cared for by other family, friends, or neighbors (Maher et al., 2008), suggesting there may be need for a larger role for parents in the management of their children when they are away from home. In addition to diet and activity, other factors that may also influence the development of overweight in preschool children need further investigation. For example Taveras et al. (2008) reported that daily sleep duration of less than 12 hours during infancy appears to be a risk factor for overweight and adiposity in preschool-aged children. Parental social stress, time limitations, work responsibilities, and absence, or other factors that may strain parent/child interactions may also be of interest. An evidence/technology assessment report (Whitlock et al., 2008) that examined weight management interventions in clinical and non-clinical community settings found that available research studies primarily enrolled children and adolescents ages 5 to 18 years and no studies targeted those less than 5 years of age suggesting a significant research gap for this age range.

Scientific Knowledge To Be Achieved through Research Supported by This Program

This FOA is designed to encourage research applications that will identify behavioral and environmental interventions appropriate for infants and young children (less than age 6 years) with potential to improve prevention or management of overweight and obesity in childhood and contribute to reduced overweight later in life.

Objectives of this Research Program

This initiative is predicated on the belief that within the home environment, parents of infants and young children can be taught to recognize children’s weight status and can serve as highly influential role models for dietary and physical activity behaviors, as gatekeepers for foods and beverages that are brought into the home environment, and as regulators of portion size, of foods eaten away from home, and of screen time (e.g., television viewing, computer use, video games, etc.), free play time, and other sedentary and physical activity behaviors. Parents have the ability to influence the development of fundamental eating, physical activity, and other influential behaviors at an early age for their children and they have the ability to provide or withhold reinforcement for these behaviors. Additionally it is likely important that the rest of the family follows the principles of a healthy lifestyle so they can serve as capable teachers, facilitators, and role models. This FOA encourages creative ways to explore the potential of parents and other caregivers including in-home day-care providers and older siblings in the home, as conduits to reach children with appropriate energy balance messages and behaviors, modify the physical environment of the home to make it more conducive to energy balance, or otherwise have a positive impact on appropriate weight gain of young children through various mediating behavioral factors.

Research and experimental approaches being sought to achieve this program’s objectives

The types of research and experimental approaches that are being sought are randomized clinical trial study designs. Behavioral interventions (e.g., self-monitoring, reinforcement strategies, motivational interviewing, and skills training) may be included in combination with approaches to change the home environment. Interventions based on well established theory or existing data are encouraged; however, due to the need to explore innovative approaches, novel approaches that are based on clinical experience and are well justified will be considered. Novel or innovative approaches that are accompanied by a convincing rationale for their use are encouraged. Applications targeting groups or populations at high risk for the development of obesity are also encouraged. Observational or descriptive studies designed to examine the correlates of overweight in the absence of an intervention will not be considered appropriate for this FOA.

Projects that include a multi-disciplinary team of investigators with knowledge and experience in working with infants and young children, parents, child care providers and other primary caregivers, as well as experts on overweight and randomized clinical trials are encouraged. Relevant disciplines would include early childhood development and education, in addition to other behavioral and social scientists as appropriate, depending on the nature of the interventions proposed.

In general, applications for interventions should reflect an understanding of the developmental needs, differences, and trajectories of infants and young children during the early childhood period (birth-age 5 years) across cognitive, physical, social and emotional domains and processes.

Examples of research topics include but are not limited to those listed below

Behavioral interventions emphasizing the role of home, parents, family, household microenvironment.
Operational parental support, reward, involvement, commitment, rules, restrictions, and engagement to achieve healthy weight and minimize weight related risk factors in young children.
Structural home changes including: food and beverage pantry content, exposure, and availability of high fat snack foods and sugar-sweetened beverages and confections such as candy or pastry.
Home television, videogame, and computer placement and availability.
Behavioral routines such as nighttime sleep and daytime napping patterns.
Multi-component interventions that incorporate family-based behavioral/lifestyle counseling, physical activity and dietary counseling, and parent modeling and reinforcement.
Interventions in infants beginning in the post-weaning period that focus on regulating the quantity, quality, and timing of complementary foods introduced into the diet.
Multi-site, trans-site interventions bridging the gap in continuity between the home, neighborhood/community, day-care, pre-school and other sites in which young children spend most of their time, encouraging greater linkage of externally-based approaches with the internal home environment (i.e., reciprocal reinforcement with increased parental involvement).
Interventions that influence: intra-family dynamics (including siblings), family relationships (including extended families); joint parent/child goal setting and family rituals to optimize balance of energy intake and expenditure (including family play, recreational sports, and fitness activities); family meals and eating occasions.
Studies attentive to cultural and ethnic influences that impact competing individual/family choices for energy intake and expenditure.
Interventions that capitalize on the role of the child as a consumer, and home, family, and parent approaches designed to utilize teachable moments for meal planning and food and beverage choices, based on family communication and interaction strategies including use of food labels, Internet, games, or other educational tools and modalities.
Interventions that address parental time, economic, and other constraints and barriers that adversely impact the purchase of low energy dense foods, home meal preparation, family meals eaten at home, and family physical activity, sedentary behaviors such as television viewing and other screen time, especially in single parent, low income, or low literacy households.
Interventions designed to reduce or manage environmental/situational social stressors to increase parental time (including work schedules, work-family balance), involvement, and attention to factors associated with energy balance in early childhood.
Interventions that enhance parental skills, parental modeling of anti-obesogenic behaviors, and parental awareness or monitoring of the eating behavior and physical activity of children (including both maternal and paternal involvement in planning children’s meals, and involvement in physical activity).
Interventions that address family coping with adverse external influences on diet, physical activity, and sedentary behaviors, including media, peer, neighbor, and neighborhood influences.
Interventions that address parenting styles (e.g., authoritarian, authoritative, permissive, indulgent) as they relate to parent feeding styles (e.g., pressure to eat, monitoring, restriction) and energy density of the child’s diet.
Interventions focusing on novel aspects of behavior that directly or indirectly influence diet and physical activity, e.g., food as an instrument of reward or punishment, perceptions of physical safety outdoors, sleep/bedtime rules, and other less documented considerations.
Interventions that integrate home and neighborhood resources or utilize human capital resources from the community such as trained Agricultural Extension Service aids, registered dietitians, or fitness trainers to provide guidance to parents and children on practices consistent with energy balance; interventions that include home visits by relevant community service providers; interventions that include anticipatory guidance recommendations provided by health care providers, applied in conjunction with the other aspects of the home/family environment.
Interventions that promote family social support for the adoption and maintenance of dietary and physical activity practices consistent with achieving and maintaining energy balance in early childhood.
Interventions that utilize non-parent child care providers external to the nuclear home/family as behavioral role models, facilitators, or change agents; including enhancing parental monitoring and regulation of activity, screen time, and foods that their young children consume in the setting of non-parent child care providers.
Interventions that focus on the introduction of low-energy dense/high nutrient dense complementary foods (instead of high-energy dense foods) in post-weaning diets.
Interventions that establish television and other screen time guidelines for the home/family shared environment, offset with increased free play time as an example of one component for regulating sedentary behaviors beginning at pre-toddler ages.
Interventions that involve re-engineering the physical home environment (stimulus control removing cues for unhealthy habits; add prompts for healthier alternatives), substitution (counter conditioning learning healthier behaviors that substitute for problem behaviors), or rewards (reinforcement management reward or punishment for taking steps in a particular direction) to achieve behavior modification related to diet or physical activity.
Interventions that focus on sleep habits and sleep habit modifications in early childhood and its impact on weight.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.
Award Project Period	The total project period may not exceed 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

SF424(R&R) Cover