Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See PA-20-272

Issued by

National Cancer Institute (NCI)

Purpose

• The Division of Cancer Control and Population Sciences (DCCPS) at the National Cancer Institute (NCI) announces this Notice of Special Interest (NOSI) to encourage NCI-funded investigators to apply for administrative supplement funds to support research addressing obesity for cancer prevention and control.  Ongoing developments in obesity prevention indicate that using multiple policy, systems, and environmental (PSE) approaches across the diverse sectors that influence obesity offer considerable promise, but few efforts have been made to carefully evaluate such whole of systems, or PSE, approaches. Foundational work is needed to help set the stage for investigators from academic institutions, cancer centers, other research organizations, and community partners to lead collaborative groups to organize, implement, and evaluate such approaches. Furthermore, determining which specific combination of PSE approaches are most appropriate for a specific community requires significant preparatory work.  These supplements will help prepare for the next generation of obesity research oriented towards cancer prevention.

Definitions

Whole of Systems Approaches (WSA) - A WSA draws on complexity science and complex adaptive systems which explain the ways in which factors and relationships interact and create sets of outcomes. WSA have been defined to include features such as: 1) Identification of a system and its boundaries; 2) Capacity building; 3) Creativity and innovation; 4) Establishing relationships; 5) Engagement; 6) Establishing strong methods for communication across the system; 7) Embedding action and policies within organizations; 8) Developing leadership throughout the system; 9) Robustness and sustainability; and 10) Monitoring and evaluation.

Policy, Systems, and Environment Approaches (PSE) - PSE approaches work at a macro level and aim to improve health by changing factors such as rules or laws (policy); organizational procedures or protocols (systems); or physical, social, and economic environments.

Background

There is consistent evidence that obesity, often defined based on elevated body mass index (BMI), is associated with increased risk of 13 cancers.  In 2020 ~42% of US adults aged 18 years and older had BMIs above 30, and an analysis of data from 2019 indicated that excess body weight was responsible for 4% to 6% of incident cancer cases among men and from 7% to 11% among women. Obesity also exhibits significant disparities, with higher rates of obesity in Non-Hispanic Black Americans (50%) and Hispanic Americans (45.6%). Behavioral interventions for obesity can contribute to weight loss, but these have not been implemented at the population level and weight regain is common upon intervention completion. More recently, the approval of glucagon-like peptide 1 (GLP-1) agonists for treatment of obesity suggests that pharmacotherapies could have a significant effect on the prevalence of obesity.  However, recent data indicate that more than half of people stop taking such drugs within a year for several reasons, including cost, experiences of a weight loss plateau, side effects, and shortages in supply.  Moreover, the expected off-label costs of GLP-1 and other drugs suggest that other approaches remain necessary.

Additionally, weight loss alone is not a complete solution to population health and cancer prevention related to energy balance, diet and alcohol intake, and physical activity.  For example, unhealthy dietary patterns, unhealthy alcohol consumption, lack of physical activity, and reduced weight but low fitness, are associated with obesity and contribute to cancer risk.  Focusing on individual pharmacological or behavioral interventions alone will not fulfill the goals of cancer prevention.

Substantial public health evidence on how to address diverse public health challenges suggests that multilevel and multisectoral approaches can maximize the success of efforts to address key modifiable risk factors.  The classic example of this approach is in tobacco control where it is well established that a combination of environmental and policy approaches (e.g., regulating sales, smoke free laws, increased taxes, and changing social norms about tobacco use), pharmacotherapy, and effective behavioral interventions (e.g., promotion of cessation counseling and web-based resources such as smokefree.gov), have resulted in a reduced prevalence of tobacco use in the US from >50% in men (1955) and >30% in women (1965) to 13% of men and 10% of women who smoked cigarettes in 2021. This reduction in smoking has in turn been a major factor in the large decreases in cancers, especially lung cancer, that have occurred in recent years.

Based on the arguments briefly mentioned above, a whole of systems approach to obesity prevention and control would include the best possible access to individual level behavioral and pharmacological approaches to obesity, and a set of PSE approaches to obesity targeted to the particular needs of communities at the municipal, county, or state level.  Examples of PSE approaches to obesity prevention include the introduction of sugar sweetened beverage taxes, point of sale nutrition labelling, investment in the built and natural environment to reduce sedentary time, promotion of active transportation, modification of school system policies to improve food quality, changes in policies and programs to address nutrition security and housing security, support for efforts to improve healthy food access in underserved areas, and many others.  Exactly which combination of PSE approaches to select depends on geographic and political circumstances, community engagement, and other factors.  These approaches will require engaging the community, local government, non-profits, and elements of the commercial sector along with the cancer and health care delivery communities.

One critical issue involves the possibility of unintended consequences and differential effects on communities and demographic groups.  For example, improvements to the built, green, and transportation environments can result in gentrification and displacement. Thus, it is critically important for teams attempting to address obesity at the whole of system level to consider equity and the history of PSE efforts in their communities of interest.

The short-term goal of the supplemental funding is to support foundational efforts that will help set the stage for greater efforts to address obesity, one of the major modifiable risk factors for cancer, as well as additional obesity risk factors that contribute to cancer such as unhealthy dietary patterns, unhealthy alcohol consumption, and lack of physical activity.

Eligibility

• Only current awardees of an active NCI-funded R01, R37, R00, P01, P30, P50, U01, UM1, UH3, U19, and/or U54 are eligible to apply.
• PDs/PIs must hold an active award supported through NCI with sufficient time (minimum 1 year) left to complete the proposed project after the supplement has been awarded within the existing project period.
• The parent award should have a clear relationship to addressing obesity for cancer prevention and control.  
• Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• If an applicant anticipates a balance of 25% or more of the current total costs for the parent grant, please contact the scientific research contact prior to applying.
• Only one supplement application per parent award will be accepted for consideration. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Research Objectives

The research objectives of this supplement notice are to: 1) Examine the prevalence of obesity in cancer center catchment areas or relevant administrative units such as cities, counties, or states, 2) Carry out an environmental scan of key collaborators and the policy landscape in these areas that are related to or addressing obesity and its determinants, and 3) Convene representatives of these groups to discuss and report out on the community and organizational readiness to develop and evaluate a whole of systems approach to obesity including both enhanced obesity care, prevention, and PSE approaches to both these aspects of obesity.

Investigators should request supplement support to do the following:

• Describe the prevalence of obesity and its behavioral determinants such as diet, alcohol, and physical activity patterns over the life course and by demographic groupings over the relevant geographic areas of interest to the applicant. Existing data describing cancer center catchment areas could contribute to this goal.
• Conduct an environmental scan to: 1) identify, contact, and convene key collaborators in areas relevant to obesity prevention and treatment, including community leaders, neighborhood partners, local health and transportation departments, health care delivery systems, collaborators from academic centers with related expertise (e.g., Schools of Public Health) and non-governmental organizations addressing diverse social determinants of health as well as health care, and executive and legislative leadership such as mayors, county councils and other elected representatives; and 2) summarize unique and salient features of the policy environment in different sectors relevant to obesity, including unique or modifiable aspects of policies involving schools, parks, transportation, health care, or prevention that could be part of future whole systems approaches to obesity.
• Carry out qualitative work and convening to explore the potential for, and characteristics of, an appropriate and significant whole of systems effort to address obesity.  Such an effort should be strongly informed by the cancer prevention and control community, and engage efforts related to other obesity outcomes such as diabetes, cardiovascular disease, mobility, mental health and cognitive function, and many other correlates of obesity. This effort should result in a meeting report and needs assessment describing opportunities and barriers towards advancing a WSA addressing obesity in the community of interest.

Applications involving collaborations between NCI grant recipients eligible for supplements and relevant local partners such as leading researchers from a university, a state or local health department, or a key community organization are encouraged. However, such partners could also be engaged after the award.

Non-Responsive Applications

Applications not responsive to this NOSI include those that:

• Solely develop or refine individual level interventions, although teams may propose to explore policies and systems that influence the availability of such interventions;
• Include a plan that is not reasonable for the proposed project to be completed, given the time and budget requested;
• Fail to propose engagement with appropriate partners partner(s) from the among community, governmental, non-governmental, health care systems, and the private sector.
• Fail to present a specific plan to engage with community organizations and leaders

Applications are not required to address all 10 WSA elements but should provide a rational if any elements are not addressed. All applicants are encouraged to discuss their applications with the scientific/research contact listed in this NOSI (below) prior to submission.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

Budget.

• The budget should not exceed $100,000 in total costs for the entire allowable 1-year project period of the application/award.
• The administrative supplement application budget is limited to 1 year only.
• Administrative supplements may only be used to meet increased costs that are within the scope of the approved award but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted; supplements designed to meet cost increases for unanticipated expenses within the original scope of the project will not be considered.

Submitting Applications.

Application Due Date: Submissions must be received by January 31, 2025, at 5:00 PM local time of applicant organization for FY 2025 funding. The NOSI will expire February 2, 2025.

• For funding consideration, applicants must include “NOT-CA-25-004" (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.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-25-004" 
• In order to facilitate efficient processing of the request, applicants are strongly encouraged to notify the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.

Page Limits:

The application must include the following sections and adhere to the following limits:

• Project Summary/Abstract: 30 lines of text
• Project Narrative: 3 sentences
• Research Strategy: 5 pages.
• Biographical Sketch: for Senior/Key Personnel and Significant Contributors only

Review and Selection Process

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds. Additionally, NCI program staff will evaluate applications using the following selection factors:

• Does the administrative supplement reasonably allow for the proposed project to be completed, given the time and budget requested?
• Are the proposed activities relevant to the parent grant and original work scope?
• Does the applicant demonstrate satisfactory progress towards achieving the aims of the parent grant, as appropriate to the current stage of the project?

Inquiries

Applicants are encouraged to discuss their application with the scientific/research contacts listed in this NOSI prior to submission.

Scientific Contacts

David Berrigan, PhD, MPH 
National Cancer Institute (NCI)
Telephone: 240-276-6752
Email: berrigad@mail.nih.gov

Jill Reedy, PhD, MPH, RDN
National Cancer Institute (NCI)
Telephone: 240-276-6812
Email: reedyj@mail.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov