RFA-DP-19-002.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-

Income Families

RFA-DP-19-002

Application Due Date: 10/24/2018

Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-

Income Families

RFA-DP-19-002

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text 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 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office (NCCDPHP ERPO) Notice of Funding Opportunity (NOFO) Title Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low- Income Families Activity Code U18 - Research Demonstration--Cooperative Agreements

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-19-002

Assistance Listings (CFDA) Number(s) 93.349 Category of Funding Activity:

Health NOFO Purpose The purpose of this NOFO is to increase the availability and number of packaged effective pediatric weight management interventions (PWMI) that can be used by healthcare, community or public health organizations to serve low-income children and their caregivers. This will be achieved by having researchers take existing evidence based PWMI, and convert them into user-friendly "packaged" materials so that the PWMI can be replicated and pilot tested in real world settings. The demonstration will provide ongoing support to children and families through the PWMI and referral to community-based resources for healthy nutrition and physical activity behaviors. The long-term goal of this NOFO is to increase the access to and uptake of acceptable, effective, and packaged PWMIs by institutions that serve low-income children.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-19-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 09/24/2018 9/24/2018

Application Due Date: 10/24/2018 https://www.grants.gov

10/24/2018

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 12/11/2018 and 12/12/2018

Secondary Review: 01/23/2019

Estimated Start Date: 04/01/2019 4/1/2019

Expiration Date: 10/25/2018 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Note: The Research Strategy component of the Research Plan is limited to 25 pages.

(See Part 2, Section IV, 7. Page Limitations).

Applications that do not comply with these instructions may be delayed or not accepted for review.

A link to this FOA will be available at Funding Opportunities Announcements | Chronic Disea se Prevention and Health Promotion | CDC

Executive Summary Purpose. This NOFO will build on prior childhood obesity research demonstration (CORD) projects in implementing a model for reducing childhood obesity among low-income children with overweight or obesity. The demonstration shall provide support to target children and their families to reduce risk factors through the appropriate use of screening, preventive, and management benefits and ongoing community supports. The purpose of this NOFO is to increase the availability and number of packaged effective pediatric weight management interventions (PWMI) that can be used by healthcare, community or public health organizations to serve low-income children and their caregivers. This will be achieved by having researchers take existing evidence based PWMI, and convert them into user-friendly "packaged" materials so that the PWMI can be replicated and pilot tested in real world settings to improve health outcomes, satisfaction, and quality of life. The long-term goal of this NOFO is to increase the access to and uptake of acceptable, effective, and packaged PWMIs by institutions that serve low-income children.

Mechanism of Support. U18 Cooperative Agreement mechanism Funds Available and Anticipated Number of Awards The estimated total level of funding (direct and indirect for entire project period in dollars) that is available for the NOFO is $12,500,000. Up to 5 awards will be made under this NOFO but the number awarded is contingent upon availability of funds and a sufficient number of meritorious applications. For each awardee, approximately $750,000 will be available per year for Budget Years 1 and 2. Approximately $600,000 will be available for Budget year 3 and approximately $200,000 will be available per year for Budget Years 4 and 5. These estimates include direct and indirect costs. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 4/1/2019 to 3/31/2020, is $3,750,000. The estimated total funding (direct and indirect) for the entire project period, 4/1/2019 to 3/31/2024 is $12,500,000.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this https://www.cdc.gov/chronicdisease/about/foa.htm https://www.cdc.gov/chronicdisease/about/foa.htm https://www.cdc.gov/chronicdisease/about/foa.htm http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.

are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the "contact PI" for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

Application Type. New Application Materials. See Section IV.1 for application materials. Please note that

Form D is to be used when downloading the application package. http://grants.nih.gov /grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 ;

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority HEALTHY KIDS Act, Section 2104(a) of the Social Security Act (42 U.S.C. 1397dd(a)), as amended by section 3201(a) of the CHIP and Public Health Funding Extension Act and Section 3003(a) (Childhood Obesity Research Demonstration) and amends Section 1139A(e) of the Social Security Act (42 U.S.C. 1320b–9a(e).

1. Background and Purpose Childhood overweight and obesity remain a pressing public health concern, affecting approximately 1 in 3 U.S. children aged 2-19 years (1. Hales 2017). In addition, some subgroups such as low-income children experience higher rates (2. Pan 2015). Childhood obesity is also a condition with serious and costly effects including increased risk for type 2 diabetes, asthma, depression, and bullying (3. Egan 2013, 4. Li 2016, 5. Van Geel 2014, 6.

Quek 2017, 7. Liu 2010). Children with obesity are at high risk for continued excess weight and related comorbidities in adulthood (8. Gordon-Larsen 2010). Children and adolescents with obesity have higher total medical expenditures and use more health services and medications compared with children who have a healthy weight (9. Trasande 2009, 10. Finkelstein 2014).

The chronic care model, as described by Wagner et al (11. Wagner 1998), organizes approaches to support chronic disease management. The Obesity Chronic Care Model (12. Dietz 2007) draws from the Wagner model and includes information systems, decision supports, delivery system design and self-management support that centers on patient self-management. This framework focuses on interventions to improve obesity-related behaviors as taking place in http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 three overlapping arenas: (1) the community and its resources and policies; (2) the health care system and payment structures; and (3) the health care provider.

Professional groups and societies, including the American Academy of Pediatrics (AAP), have recommended that health care providers (including physicians, nurses, nurse practitioners, psychologists, dietitians and health coaches) organized as multidisciplinary teams address weight management and lifestyle issues with all pediatric patients on a routine basis (13. Barlow 2007, 14. Daniels 2015). Assessment begins with screening by measuring height and weight and plotting body mass index (BMI). Children with a BMI greater or equal to the 85th percentile for their age and sex should receive counseling interventions tailored to the individual child and family, and staged by the patient's age and degree of excess weight, should utilize motivational interviewing and comprehensive behavioral components. For children with obesity, more intensive intervention programs are required, and may occur both in clinical and community settings.

In 2017 the U.S. Preventive Services Task Force (USPSTF) reviewed the existing literature related to screening and management of childhood obesity. The Task Force recommended that clinicians screen all children aged 6 years and older for obesity by measuring BMI and offer or refer children with obesity to comprehensive, intensive behavioral interventions that are moderate to high intensity (>26 contact hours over 2-12 months) to promote improvements in weight status and improvements in cardiovascular and metabolic risk factors (15. USPSTF 2017). Other groups such as the American Psychological Association and the Endocrine Society have similar Clinical Practice Guidelines stating that clinicians should provide referrals to family-based, multicomponent behavioral interventions, with a minimum of 26 contact hours, initiated at the earliest age possible for children aged 2 to 18 years with overweight or obesity

(16. APA 2018 17. Styne 2017).

Despite national recommendations, and supporting scientific evidence, there remain multiple barriers to the operationalization of these recommendations for all children. Performance measure data from the National Committee on Quality Assurance's (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) indicate that in 2016 the BMI assessment by primary care providers for children 3-17 years old was <70% nationally, and <66% and <58% receive recommended nutrition and physical activity counseling, respectively (18. NCQA 2017). There is little information available on the rate of referral, and successful enrollment in a weight management program, once BMI screening is completed. One study noted that out of >4700 patients referred to a comprehensive weight management clinic 59% never attended a single visit (19. Shaffer 2016). Researchers in Texas looked at the number of children with a BMI >85th percentile who were eligible for referral into an evidence based pediatric weight management study and found that only 26% of eligible children were referred to the study.

Moreover, they found that only 27% of those referred actually enrolled. Enrollment was associated with being Hispanic and a higher severity of obesity illustrating the challenges of referral and enrollment into pediatric weight management interventions (20. Barlow 2017).

Low rates of referral to, and attendance in, pediatric weight management programs may be due to a variety of factors. Parental surveys cite referral procedures, costs, logistics, mismatched expectations and child motivation as barriers to completing a referral. (21. Hampl 2013, 22.

Kulick 2017). Low rates of referral into programs may also be another reason children are not receiving guideline based care. For example one study found that at the practice level, primary care providers initiate referrals to community-based weight management programs for only

52% of children with obesity without complications and only 66% of children who have obesity with complications (23. Libert 2018). Finally, hospital-based weight management programs are typically limited in number and 52% of registered programs offer low-intensity services that do not meet USPSTF recommendations (24. Kirk 2016).

In 2015 a multidisciplinary group of stakeholders, brought together through the support of the American Academy of Pediatrics (AAP) Institute for Healthy Childhood Weight, The Agency for Healthcare Research, and The Obesity Society, met to discuss how to improve access to evidence based childhood obesity treatment (25. Wifley 2017). The group put forth best practices and concluded that the treatment of obesity does not occur as an acute episode of care, and as such, the chronic care model should be utilized. The group expressed that efforts are needed to accelerate uptake of the USPSTF recommendations by increasing the access and reimbursement to evidence based obesity treatment. These programs would need to integrate the critical components of a family-based pediatric weight management program, the continued cross-sector collaborations to ensure a unified approach, and also have a supportive infrastructure including improved reimbursement for such treatments. National groups have also noted the challenges which weight management programs face in long-term sustainability because many programs or services are not fully reimbursed and/or are currently supported through in-kind or grant funds (26. Children's Hospital Association 2013).

To aid moving research into practice the CDC's National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) developed the Knowledge to Action (K2A) framework (27.

https://www.cdc.gov/chronicdisease/pdf/k2a-framework-6-2015.pdf). This framework outlines the process necessary to move from discovery into action through the translation of evidence based programs and practices into routine public health and healthcare practice. One way of translating interventions is by packaging intervention protocols and materials into user-friendly materials. These packaged interventions improve the capacity of others to replicate the intervention. This model has been used extensively by CDC for HIV prevention (28. Collins 2011).

Currently, there are a small number of pediatric weight management programs with low attrition, that have been shown to effectively improve children's weight and health via rigorous testing such as randomized controlled clinical trials (RCTs) (25. Wilfley 2017, 15. USPSTF 2017). There are a few PWMIs that that: 1) meet the USPSTF recommendations for dose and intensity, and are feasible and acceptable to low-income families, and 2) are "packaged". To address the current gap in the care and treatment of children who are overweight or who have obesity, more PWMIs that have been research tested and rigorously evaluated are needed to package into programs and be pilot tested to help children and families struggling with obesity.

Purpose:

The purpose of this NOFO is to increase the availability and number of packaged effective PWMIs that can be used by healthcare, community or public health organizations to serve low-income children and their caregivers. Packaging consists of researchers taking an existing evidence based PWMI, and converting into user-friendly "packaged" materials, meaning that they contain all materials necessary, for easy, efficient and complete replication by clinical or community entities. Grantees will then replicate pilot test this PWMI package in real world settings to improve health outcomes, satisfaction, and quality of life. The long-term goal of this

NOFO is to increase the access to and uptake of acceptable, effective, and packaged PWMIs by institutions that serve low-income children.

The overarching primary research question that will be answered is:

Can existing effective evidence-based PWMIs be packaged and implemented in clinical sites or community venues other than those from which the PWMI originated, be acceptable to lower-income families, and achieve intended outcomes among low-income children aged 2-12 years with obesity?

Healthy People 2020 and other National Strategic Priorities This NOFO supports the 2020 Healthy People (29) Nutrition, Weight Status and Physical Activity topic areas.

Public Health Impact This research opportunity has the potential to address the pressing public health problem of childhood obesity by increasing the availability of evidence based PWMI for millions of at-risk low-income children, especially CHIP and Medicaid eligible children. This NOFO will provide an opportunity for interventions with a solid research base to be packaged and implemented within new organizations. This process contributes to the pediatric obesity field by evaluating the effectiveness of proven interventions in real-world settings (27.K2A framework) resulting in improved public health knowledge of how to bring PWMI interventions to practice. Evidence based packaged PWMIs created from this research can be used by state and federal agencies, community based organizations, healthcare organizations and scaled to a variety of circumstances and payers.

Relevant Work This NOFO will address the problem of how to manage childhood obesity and will build on lessons learned from previously funded Childhood Obesity Research Demonstration projects (CORD) 1.0 and 2.0 (30. https://www.cdc.gov/obesity/strategies/healthcare/cord1.html ), and with relevant capacity-building assistance (CBA) projects with nongovernmental public health components such as the National Association of Community Health Centers (NACHC). This NOFO utilizes the NCCDPHP Knowledge to Action Framework and builds off of work to replicate and disseminate effective programs from other CDC Divisions, such as HIV (31.

https://www.cdc.gov/hiv/research/interventionresearch/rep/index.html; 28. Collins 2011), arthritis (32. https://www.cdc.gov/arthritis/interventions/index.htm ), and diabetes (33.

https://www.cdc.gov/diabetes/prevention/index.html ).

2. Approach Grantees will be funded for a 5 year period with varying funding levels throughout the project period due to the number and nature of activities anticipated (see objectives/outcomes below).

The approach builds on prior childhood obesity research demonstration (CORD) projects in implementing a model for reducing childhood obesity among low-income children with overweight or obesity. The demonstration shall provide support to target children and their families to reduce risk factors through the appropriate use of screening, preventive, and management benefits and ongoing community supports. The demonstration will carry out activities to increase the availability of packaged effective pediatric weight management interventions (PWMI) that can be used by healthcare, community or public health organizations to serve low-income children and their caregivers. To achieve this, researchers/research teams will take the existing evidence based PWMI and create a "package" that supports all required elements for implementing the evidence based intervention in other locations, including all supporting materials in user-friendly formats, implementation manuals, training curricula, technical assistance and evaluation/quality control materials and pilot test them in real world settings. Awardees will conduct a rigorous research study to assess implementation, delivery system and child/family outcomes as they pilot the PWMI materials package in two or more clinical or community organizations. This approach can strengthen local, state and national public health chronic disease prevention and treatment efforts by presenting an opportunity for scientists to translate their proven behavioral interventions into practical materials for more widespread implementation. This NOFO aims to include a diversity of PWMI packages that draw upon effective, innovative models to reduce behavioral risk factors and improve health.

For example PWMIs that target different age ranges, such as PWMIs that include: younger children (aged 2 to 5), school aged children or older children; or PWMIs that are targeted to different racial or ethnic groups; or that include different intervention approaches or settings, such as those that are individual, group based, online, or mixed formats.

The PWMIs targeted for this funding announcement must have a solid and rigorous evidence base. For example, interventions included in the evidence reviews for the 2010 or 2017 USPSTF Recommendation for childhood obesity, or other similarly rigorous systematic reviews. The successful applicant should provide supporting information in their research plan that demonstrates the PWMI has been: 1) rigorously evaluated such as in the form of a Randomized Control Trial (RCT); 2) meets the USPSTF recommendations for dose and intensity; 3) is family based; 4) includes nutrition and physical activity counseling; and 5) improves BMI in children 2 to 12 years old.

During the 5-year funding period applicants are required to take their evidence-based PWMI intervention and: 1) "package" together all materials necessary to carry out the PWMI in a user-friendly turn-key format; 2) conduct a pilot implementation research study and aid pilot sites in engaging with multisectoral stakeholders to refer children and families to PWMI and help link to community resources for healthy nutrition and physical activity; 3) finalize their PWMI based on data and feedback from the pilot implementation study; and 4) develop a sustainability and dissemination plan.

This NOFO specifically targets PWMIs that can be implemented by providers and organizations that serve low-income children ages 2 to 12 years affected by childhood obesity, such as children covered CHIP or Medicaid programs. The applicant will need to fully describe plans for creating the "package" of PWMI materials. The package will need to consider multiple components including nutritional content, understanding and responding to hunger and satiety, positive body image development, positive self-esteem development, and learning life skills (such as stress management, communication skills, problem solving and decision making skills), as well as consideration of cultural, family, peer, and developmental issues. The package must include all materials necessary for a new provider/organization to implement the intervention such as an implementation manual, a training curriculum, technical assistance (TA) and evaluation materials.

The applicant will conduct pilot implementation research by identifying and collaborating with at least two additional healthcare, community or public health organizations, that serve low-income children and families aged 2 to 12 as part of their patient population. These two local organizations will use the package of training, technical assistance, evaluation and intervention manual materials in their real-world setting. During the pilot the grantee will collect data on: 1) outcome measures commonly used in implementation research (e.g., acceptability, adoption, appropriateness, cost, and fidelity); 2) delivery system/service outcome measures (e.g., efficiency, effectiveness, timeliness, patient centeredness); and child/family outcome measures to determine if children and families participating in the pilot sites improved health outcomes and BMI through participation in the PWMI (34. Proctor et al, 2011). Rigorous designs for the implementation research study should be used such as those that utilize designs common to the fields of quality improvement, evaluation or implementation research. These designs could involve matched comparison groups, propensity-score matching, instrumental variable methods, regression discontinuity, time series designs, hybrid or other designs. Applicants should not include experimental research designs (i.e., randomized controlled trials [RCT]), as the intention of this NOFO is to implement interventions that have already documented efficacy via RCT. Data analytic plans should be appropriate to the implementation strategy, research design, hypotheses, and data collection measures.

Pilot sites will also document their experiences in recruiting and retaining enrolled children and families to participate in the PWMI and linking children and families to community resources.

Finally, the pilot sites will also provide feedback to the research team on the PWMI package of materials.

At the end of the project period CDC aims for grantees to have a packaged program, built on a strong evidence base, that organizations can obtain and that can be widely disseminated for implementation in healthcare, community or public health settings that that includes a strategy for extending program activities. Data generated through the implementation research pilot will assess relevant outcomes from the evidence based PWMI implementation in real world settings, and will determine how similar the outcomes were to those of previous trials of the PWMI.

Over the course of the project period there may be other supplemental opportunities to support enhanced PWMI activities. Examples of such activities include additional package testing, additional site testing, and dissemination.

Objectives/Outcomes The grant has specified objectives, activities, and outputs/outcomes that are described in detail below. The demonstration project should identify and build upon existing community, regional and state resources, and relationships. The overarching outcome is to increase the availability and number of packaged effective PWMIs that can be used by healthcare, community or public health organizations that serve low-income children. Each year of funding will build on the previous year's activities to reach the NOFO's desired objectives and outcomes.

Objective 1: Develop an intervention package that includes all materials necessary for others to implement the intervention in new places. This includes the following activities:

package the curriculum, sessions, intervention activities, engage with community coalition partners and develop family support and educational materials such as templates to help link families to needed community resources and supports such as food assistance services, healthy lifestyles, or increased access to safe places for physical activity (i.e. after hours physical activity programs and opportunities through schools, parks and recreational services or community based organizations);

develop training materials and training capacity;

develop a minimum set of evaluation criteria for PWMI and a way to track key outcomes typically used in implementation research (34. Proctor et al, 2011) such as:

o implementation outcomes (e.g., acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration/reach and sustainability) o delivery/service outcomes (e.g., efficiency, safety, effectiveness, equity, patient/family centeredness, timeliness) o child and caregiver outcomes (e.g. acceptability, satisfaction, patient dose received over what period of time, quality of life, obesity-related behaviors, other health outcomes and BMI) develop fidelity measures and a way to track program fidelity;

develop a method to collect information on the cost including cost of the intervention materials, the cost of delivery, and the cost of implementation; and in conjunction with pilot sites, obtain all approvals necessary, such as IRB or others, to carry out the pilot research study and develop a plan for recruiting children into the

PWMI.

The anticipated outputs from objective 1 include: the package including all supporting materials in user-friendly formats, implementation manuals, training curricula, the provision of technical assistance and an evaluation and cost monitoring system.

Objective 2: Perform a rigorous pilot implementation research study that tests the intervention in at least two new organizations. This includes the following activities:

provide PWMI materials, community resource referral materials, technical assistance and training to implementing sites;

provide implementation support activities and aid pilot sites in engaging broad ranging multisectoral stakeholders as necessary;

monitor outcomes used in the implementation research pilot; and, begin sustainability and dissemination planning:

o determine/test if the PWMI interventions could be mapped to services eligible for reimbursement; and o outline a plan to create a system or structure for others to obtain the intervention, including elements such as a dissemination plan, website, fee structure, and/or training system; and o develop a strategy for extending program activities

The anticipated outputs and outcomes from objective 2 include: materials and support necessary to carry out the pilot implementation research study in at least two new organizations. Grantees will begin data collection on outcomes used in the implementation pilot and produce a draft sustainability and dissemination plan.

Objective 3: Complete a pilot study and finalize the PWMI package materials and sustainability and dissemination plan. This includes the following activities:

complete the pilot study and evaluate the pilot study outcomes;

make edits to the PWMI package based on pilot experience, finalize the package materials, and provide to CDC for review;

finalize a sustainability and dissemination plan for additional sites to further spread and scale.

o In collaboration with CDC, determine if there are other potential sites for dissemination.

o If disseminated to other sites, sustain a system for technical assistance, perform implementation outcome monitoring (such as fidelity, adoption, and penetration/reach), and utilize a system to monitor key processes and outcomes);

Compile lessons learned and produce an evaluation synthesis report and aggregate program statistics; and

Present findings in published literature and conferences.

The anticipated outputs and outcomes from Objective 3 include: Completion of the pilot study;

a summary of pilot findings; finalized PWMI package; a sustainability and dissemination plan;

an evaluation synthesis report; and presentations and publications.

Target Population The priority population of this NOFO is low income-children ages 2-12 years who are overweight or have obesity and their families. Applicants should thoroughly describe the populations included in prior trials of their PWMI interventions and the proposed implementation pilot population, including the age range, racial/ethnic mix, income or poverty level, BMI level (or distribution of weight category) and other relevant population characteristics.

Collaboration/Partnerships The applicant should identify any key stakeholders that are included in this project and how these collaborations/partnerships will allow the applicant to complete the proposed work.

Expected collaborations include:

A collaboration between the applicant institution and other outside entities necessary to complete the proposed work, such as the two pilot site collaborators, is required. The grantee may also collaborate, and form partnerships, with other entities that are necessary to provide evaluation expertise, access to data, or other types of project support. Documentation of partnerships should describe existing working relationships, plans for the proposed collaboration, nature and extent of involvement of the PI, applicant institution, outside entities, and partner agencies, as well as the scope of work for the outside entity. If partnerships are related to obtaining data from another group (e.g., data from electronic medical records), the applicant should document that they will have access to that data.

Forming a community advisory board consisting of broad stakeholders such as local health professionals/provider agencies; community health workers; community-based organizations; local governments; local educational agencies; the private sector; State or local departments of health; healthcare providers and members of the intervention's intended populations (families with children ages 2 to 12). Key stakeholders should be engaged early and involved throughout the grant period.

Forming a payer advisory board consisting of stakeholders from entities such as State Medicaid, private payers, State and/or Local Health Agencies, federally qualified health center or primary care association, major health systems or foundations to help understand potential for sustainability and reimbursement of the PWMI.

Collaborations/partnerships during the project period to enhance awareness and uptake of packaging and pilot work such as : 1) state and/or local departments of health in close geographic proximity during the development of the dissemination and sustainability plans 2) organizations or entities that can support pilot sites in engaging with existing multisector stakeholders in childhood obesity efforts and refer children and families to the PWMI and to community resources for healthy nutrition and physical activity to increase awareness and collaboration

Attending bi-weekly or once monthly CDC grantee conference calls and participate in all annual CDC site visits.

Evaluation/Performance Measurement Applicants must evaluate and document performance during each stage of the PWMI

"packaging", implementation pilot and dissemination planning processes. Applicants should describe how they will evaluate the project objectives outlined above. The evaluation plan should include key grant related activities, as appropriate for each objective, such as partnership development, packaging, pilot implementation study development, recruitment, training, process and outcome measurement, data collection, participant retention, data analysis and dissemination.

The applicant is expected to provide a clear description of relevant measures for each objective of the project. Comparison of actual progress to the project aims and objectives is expected to document whether the demonstration project is progressing appropriately, in a timely manner, and whether planning, packaging, research or dissemination activities are of high quality.

Translation Plan The applicant should outline a preliminary plan describing how the packaged PWMIs and training materials will be made available to providers who want to obtain the packaged materials and training. The plan should also outline the estimated costs associated with implementing the PWMI after the pilot. Applicants should outline a sustainability plan for the PWMI package to support ongoing or future implementations.

OMB/PRA is not expected to apply References:

1. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity Among Adults and Youth: United States, 2015-2016. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2017.

2. Pan L, McGuire LC, Blanck HM, May-Murriel AL, Grummer-Strawn LM. Racial/ethnic differences in obesity trends among young low-income children. Am J Prev Med. 2015;

48(5):570-574.

3. Egan KB, Ettinger AS, Bracken MB. Childhood body mass index and subsequent physician-diagnosed asthma: a systematic review and meta-analysis of prospective cohort studies. BMC Pediatr. 2013; 13:121.

4. Li L, Perez A, Li-Tzy W, Ranjit N, Brown HS, Kelder SH. Cardio metabolic Risk Factors among Severely Obese Children and Adolescents in the United States, 1999?2012. Childhood Obesity 2016; 12 (1): 12-16.

5. Van Geel M, Vedder P, Tanilon J. Are overweight and obese youths more often bullied by their peers? A meta-analysis on the relation between weight status and bullying. Int J Obes. 2014; 38(10):1263.

6. Quek YH, Tam WWS, Zhang MWB, Ho RCM. Exploring the association between childhood and adolescent obesity and depression: a meta-analysis. Obesity Rev. 2017;

18(7):742-754.

7. Liu LL, Lawrence JM, Davis C, et al. Prevalence of overweight and obesity in youth with diabetes in USA: the SEARCH for Diabetes in Youth study. Pediatr Diabetes.

2010; 11(1):4-11.

8. Gordon-Larsen P, The NS, Adair LS. Longitudinal trends in obesity in the United States from adolescence to the third decade of life. Obesity. 2010;18(9):1801-1804

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10. Finkelstein EA, Chen W, Graham K, Malhotra R. Lifetime direct medical Costs of Childhood Obesity. Pediatrics 2014; 133:854-862

11. Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Effective Clinical Practice. 1998;1(1):2-4

12. Dietz W, Lee J, Wechsler H, et al. Health plans? role in preventing overweight in children and adolescents. Health Affairs 2007; 26: 430-440.

13. Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity:

summary report. Pediatrics. 2007; 120 (Suppl 4):S164-192.

14. Daniels SR and Hassink SG, COMMITTEE ON NUTRITION (2015) The Role of the Pediatrician in Primary Prevention of Obesity Pediatrics Vol 136 (1)e275-292;

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16. US Preventive Services Task Force. Screening for Obesity in Children and Adolescents

US Preventive Services Task Force Recommendation Statement. JAMA.

2017;317(23):2417-2426

17. Styne DM, Arslanian SA, Connor EL, Farooqi IS, Murad MH, Silverstein JH, Yanovski JA. Pediatric Obesity?Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102(3): 709-757.

18. National Committee on Quality Assurance. State of Health Care Quality 2017. Accessed at http://www.ncqa.org/report-cards/health-plans/state-of-health-care-quality/2017-table-of-contents/weight-assessment

19. Shaffer LA, Brothers KB, Burkhead RA, Yeager R, Myers JA, Sweeney B. Factors associated with attendance after referral to a pediatric weight management program. J Pediatr 2016; 172: 35-39.

20. Barlow SE, Butte NF, Hoelscher DM, Salahuddin M, Pont SJ. Strategies to Recruit a Diverse Low-Income Population to Child Weight Management Programs From Primary Care Practices. Prev Chronic Disease 2017

21. Hampl S, Demeule M, Eneli I, Frank M, Hawkins MJ, Kirk S, Morris P, Sallinen BJ, Santos M, Ward WL, Rhodes E. Parent perspectives on attrition from tertiary care pediatric weight management programs. Clin Pediatr 2013; 52(6): 513-519.

22. Kulik NL, Thomas EM, Iovan S, McKeough M, Kendzierski S, Leatherwood S. Access to primary care child weight management programs: urban parent barriers and facilitators to participation. J Child Health Care 2014; 21(4): 509-521

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5/25/2018

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Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

http://www.childrenshospitals.net/obesitysurvey https://www.cdc.gov/chronicdisease/pdf/k2a-framework-6-2015.pdf https://www.cdc.gov/chronicdisease/pdf/k2a-framework-6-2015.pdf https://www.cdc.gov/obesity/strategies/healthcare/cord1.html https://www.cdc.gov/diabetes/prevention/index.html https://www.cdc.gov/diabetes/prevention/index.html

Estimated Total Funding: $12,500,000 The estimated total funding (direct and indirect costs) for the first budget period is $3,750,000, and the estimated total funding (direct and indirect) for the entire project period is $12,500,000 for the project period of 4/1/2019 to 3/31/2024 It is anticipated that award(s) will be made under this CDC-RFA-DP19-002, with an average funding level of $2,500,000 per grantee over the project period.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Anticipated Number of Awards: 5

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $750,000 Per Budget Period Award Floor: $200,000 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements As determined by legislative language, eligible applicants include the following:

A city, county, or Indian tribe.

A local or tribal educational agency.

An accredited university, college, or community college.

A Federally-qualified health center.

A local health department.

A health care provider.

A community-based organization.

4. Justification for Less than Maximum Competition Statutory Authority and Congressional language specifically identifies eligibility entities listed in Section III (1).

5. Responsiveness Applications under this program must meet the requirements set out under (1) Eligible Applicants and (3) Special Eligibility requirements. These requirements are the minimum necessary in order for an application to be responsive and sent forward for scientific peer review. If your application is incomplete or non-responsive to the eligibility requirements in these sections, it will not enter into the review process.

6. Required Registrations Applicant…