dp11-007 foa final amend iv 4.15.11.doc

Amendment IV made 4.15.11

(a) Closing date: April 25, 2011, by 5:00 PM Eastern Time.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM Eastern Time. Any applications submitted after the closing date will not be accepted. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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).

(b)Applicants who have successfully submitted applications for this announcement are not required to resubmit another application. HOWEVER, APPLICANTS WHO HAVE PREVIOUSLY SUBMITTED MAY REAPPLY IF THEY WISH.

4.14.11: Amendment III was removed from Grants.gov pending further notice as stated on the Synopsis.

Amendment III made 4.13.11

(a) Closing date: April 18, 2011, by 5:00 PM Eastern Time.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM Eastern Time. Any applications submitted after the closing date will not be accepted. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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).

(b)Applicants who have successfully submitted applications for this announcement are not required to resubmit another application Amendment II made 3.11.11:

Attachment 1: Questions and Answers about the FOA Clarification of the Research Demonstration Project Plan and Objectives (Component A), pages 12-13 Clarification of Role of Demonstration Sites in Conducting Cost and Cost-Effectiveness Analyses, page 13

Clarification of Eligibility Criteria, page 21 Clarification of Score Review Criteria, pages 30 and 33 Amendment I made 2.4.11:

(a) Title Change Page 1

(b)Access information for Teleconference/ webcast on February 16, 2011 (see Key Dates, Teleconference, pages 3-4);

(c) Clarification of number of awards and funding levels anticipated for Component A-Demonstration Sites and Component B-Evaluation Center (see Section II, Award Information, Funds Available and Anticipated Number of Awards, pages 18-19); and

(d) Clarification on one Additional Information on Eligibility (see page 21).

Hidden text in all capital letters is specific ERPO guidance.

Department of Health and Human Services

Part 1. Overview Information

Health Resources and Services Administration (HRSA at http://www.hrsa.gov)

The Center for Medicare & Medicaid Services (CMS at http://www.cms.gov/), the Administration for Children and Families (ACF at http://www.acf.hhs.gov/index.html)

Mechanism of Support

U18 Research Demonstration – Cooperative Agreements

Some activity codes may need prior approval or may have limited use, and CIO may or may not have authority for each activity code. Add the relevant activity code, if not listed above. Please see the Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs for more information.

Announcement Type

NewKeep relevant text; enter previous FOA Number if a reissuance

Error! Hyperlink reference not valid.

e.g.:

Health

Component A

The objective of the demonstrations is to determine whether an integrated model of primary care and public health approaches in the community can improve underserved children’s risk factors for obesity. These approaches may include policy, systems, and environmental supports that encourage nutrition and physical activity for underserved children and their families.

Grantees will develop, implement, and evaluate multi-sectoral (i.e., childcare, school, community, health care), multi-level (i.e. child, family, organization, community, policy) intervention demonstration projects for underserved children ages 2-12 years and their families utilizing the Obesity Chronic Care Model and other similar models. The Obesity Chronic Care Model provides a framework to integrate primary care and public health approaches with an intent to guide the design of strategies, approaches, systems, and/or tools to ultimately prevent and reduce childhood obesity.

Component A Demonstration Project funded grantees will design, implement, and evaluate the demonstration interventions, with evaluation support from the Component B Evaluation Center funded grantee. Standardized measures across sites will be collected to determine whether the demonstration research project led to changes in preventive services, policy, systems, and environment (e.g. setting, community), and individual outcomes including health, satisfaction, health care utilization and quality of life.

Component B

The results of the Demonstration projects will be used to generate a recommendation that determines whether program components, similar to the awarded demonstration projects, should be implemented nationally for the general population of children who are eligible for child health assistance under Title XXI (CHIP) of the Social Security Act.

The Component B funded grantee, the Evaluation Center, will design and conduct the overarching evaluation that will support this recommendation, in collaboration with the Component A Demonstration Project funded grantees and CDC.

Key Dates

Publication Date

PGO will add this information when posted. This field is not available for CIO edit.

January 19, 2011

Send LOI to:

Michael Dalmat, Dr.P.H.

med1@cdc.gov , 770-488-6046 FAX. or

FedEx Address:

Koger Center-Davidson Building, Room 1098

2858 Woodcock Boulevard

Atlanta, GA 30341

Webcast Details To participate in the Webcast, telephone and Internet access are needed.

Date: February 16, 2010 Time: 4:00pm – 5:45 PM EST Telephone call-in information:

Phone #: 1-888-843-9981 Passcode: 3004616

Internet log-on instructions

Compatibility:

Please check your system to make sure it is compatible with Microsoft Office Live Meetinghttp://go.microsoft.com/fwlink/?linkid=52354.* You will have the best compatibility using a Windows PC with Internet Explorer.

Log-on instructions:

Please log onto the site below and call in 15 minutes before the meeting (at 3:45 PM EST). Doing so will eliminate delays in case you run into any log in problems.

Web address to log in directly to the webcast:

https://www.mymeetings.com/nc/join.php?i=PW1014267&p=3004616&t=c Once you click on the above link, the conference number and passcode should appear in the appropriate boxes. Enter your first and last name in the boxes. If you are sharing a computer, enter in the first and last name of the contact person.

If the conference number and passcode do not appear automatically, then enter the following into the boxes;

Conference number: PW1014267 Audience passcode: 3004616 Additional information can be found at:

http://www.cdc.gov/prc/newsroom/2009-CER-FOAwebcast.htm Applicants are strongly encouraged to attend the web-cast meeting.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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).

Will be conducted by CDC to more fully understand and validate the capacity of the applicant communities with the highest Scientific Merit Review Scores: Late June 2011

Secondary Review: July 2011

Rarely applicable See THIS IS ONLY USED WHEN STATE HEALTH DEPARTMENTS ARE INVOLVED http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7 for details.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

Note: The Research Plan is limited to 25 pages.

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

Note: Up to 10 appendices may be included in the application. Appendices may not exceed 60 pages total. Any pages beyond 60 in the appendices may not be reviewed by the Scientific Merit Review panel members.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

“Apply Electronically” Text and link inserted here by PGO.

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 The prevention and reduction of obesity is a priority of the Centers for Disease Control and Prevention (CDC). To this end, the Division of Nutrition Physical Activity, and Obesity (DNPAO), National Center for Chronic Disease Prevention and Health Promotion, engages in a public health approach to improve diet quality, increase physical activity and reduce obesity, including surveillance, applied research, and communications, and supports public health programs that focus on policy, systems, and environmental change in multiple-settings, including childcare, school, worksites, hospitals, and other sectors of the community. This FOA addresses the development of a multi-level and multi-sectoral intervention that links primary care with public heath approaches and promotes behavioral change in conjunction with policy and environmental changes. The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC within the Department of Health and Human Services (HHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020." This RFA addresses “Healthy People 2020” priority area(s) of Focus Area 19: Nutrition and Overweight and Focus Area 22: Physical Activity and Fitness and is in alignment with performance goal(s) to Goal 6, Performance Measure 1(HHS FY 2008 Congressional Justification). For more information go to http://www.healthypeople.gov/ and http://www.whitehouse.gov/omb/mgmt-gpra/. The CDC has identified several priority areas through which measurable impact can be achieved in a short time in key areas of public health. The Division of Nutrition, Physical Activity, and Obesity shares responsibility for the nutrition/obesity priority area.

Within this priority area, CDC is pursuing strategies to:

1. Eliminate artificial trans fat in the food supply;

2. Reduce sodium levels in processed and restaurant foods;

3. Implement nutrition standards for foods marketed to children;

4. Increase consumption of fruits and vegetables;

5. Promote healthy food environments (e.g., discourage unhealthy food and drink consumption in public venues, healthy hospital environments);

6. Provide nutrient information to consumers and improve their ability to use that information to make informed purchases (i.e., front of package, menu, nutrient fact labels); and

7. Increase the number of persons who achieve the physical activity guidelines.

Items 3-7 are directly addressed in this FOA. The goal areas of the CDC’s Division of Nutrition, Physical Activity, and Obesity are to: Increase health-related physical activity through population-based approaches; Improve those aspects of dietary quality most related to population burden of chronic disease and unhealthy child development; Decrease prevalence of obesity through prevention of excess weight gain and maintenance of healthy weight loss. A guiding principle of the Division is to reduce health disparities.

Nature of the Research Opportunity

This Funding Opportunity Announcement (FOA) solicits Research Demonstration Cooperative Agreement (U18) applications to:

(1) Develop, implement, and evaluate intervention demonstration projects for underserved children ages 2-12 years and their families that include multiple sectors (at a minimum childcare, school, community, and health care), intervening at multiple-levels (i.e. child, family, organization, community, policy), and utilize the Obesity Chronic Care Model (http://content.healthaffairs.org/cgi/content/abstract/26/2/430) and other similar models. . The objective of the demonstrations is to determine whether an integrated model of primary care and public health approaches in the community such as policy, systems, and environmental supports for nutrition and physical activity can improve underserved children’s risk factors for obesity.

The program design should draw upon promising, innovative models and incentives to achieve measurable outcomes, including reducing obesity-related behavioral risk factors and improved weight status. The design must include policy, systems, and environmental community-oriented activities, child care based activities, school based activities, health care delivery system activities such as those provided by medical providers serving Medicaid/CHIP enrollees, and activities for community health workers (defined as any member of a community or community based organization who provides behavioral counseling or assistance in navigating health care services and community resources). The project is to provide multi-component strategies that promote healthy behaviors for children and their families by providing consistent policy changes on obesity-related behaviors and transforming the environments within which children participate in the community to create safe physical activity opportunities and healthy food access to ultimately improve healthy behaviors and reduce obesity.

(2) Generate a recommendation from implementation and outcome evaluation findings that determines whether programs or program components similar to the awarded demonstration projects could be replicated in a variety of communities to inform decisions about national implementation for children in diverse communities who are eligible for services under Title XXI if they have proven to prevent, reduce, or stabilize obesity in targeted populations.

The goals of this initiative are to create supportive environments and to improve health outcomes including measurable changes in nutrition and physical activity behaviors and in weight status, health care service delivery and utilization, quality of life and satisfaction among children who are eligible for child health assistance under the State child health plans. It is also expected that projects funded under this announcement will impact public health by contributing to the reduction of the overall burden of obesity on society.

Background

Childhood obesity is a major public health problem. Results from the 2007–2008 National Health and Nutrition Examination Survey (NHANES), using measured heights and weights, indicate that an estimated 16.9% of children and adolescents aged 2–19 years are obese (Ogden 2010). Among children aged 2–5 years, obesity increased from 5.0% to 10.4% between 1976–1980 and 2007–2008 and from 6.5% to 19.6% among those aged 6–11. Moreover, racial/ethnic disparities are evident early in life. CDC examined trends and current prevalence in obesity using Pediatric Nutrition Surveillance System (PedNSS) data submitted by participating States, territories, and Indian tribal organizations during 1998—2008 (http://www.cdc.gov/obesity/data/index.html). The findings indicated that obesity prevalence among low-income, preschool-aged children increased steadily from 12.4 % in 1998 to 14.5 % in 2003, but subsequently remained essentially the same, with 14.6 % prevalence in 2008. Despite the overall plateau observed in both NHANES and PedNSS, disparities in recent obesity rates persist among underserved subgroups. In the PedNSS data, prevalence was highest among American Indian/Alaska Native (AI/AN) children (21.2%) and among Hispanic children (18.5%). The Children’s Health Insurance Program (CHIP) specifically enrolls children who have been identified to a disproportionate rate of obesity based on socioeconomic status. Furthermore, CHIP also enrolls many minority children and adolescents who are disproportionately burdened by obesity as shown by U.S. surveillance information. As such, there is a well-defined need to target obesity prevention and control interventions among these underserved groups of children enrolled in CHIP.

Obese children are at greater risk for numerous health consequences, including cardiovascular disease and type 2 diabetes. Overweight adolescents have a 70 percent chance of becoming overweight or obese adults (Freedman 2005). Analyses using the Medical Expenditure Panel Survey (MEPS) indicate that obese children and adolescents 6-19 years of age have higher annual medical care and utilization costs compared to normal/underweight children by approximately $3 billion (Trasande 2009).

Recognition that childhood obesity is a major public health problem with a complex network of etiological factors and associated comorbidities has prompted numerous organizations to call for collective efforts to combat the problem from multiple fronts, including innovative research. In 2007, the National Heart, Lung, and Blood Institute (NHLBI) and other NIH Institutes convened a Working Group that recommended that future research on childhood obesity prevention and treatment interventions adhere to the following: careful evaluation designs that explore what is working or not and for whom; be generalizable and have high impact and promise for sustainability; include stakeholders (families, school and environments) in decision making; use qualitative methods to inform intervention design; report on the developmental and design stages of interventions; and include process measures, cost-effectiveness analysis and appropriate statistical analyses (http://www.nhlbi.nih.gov/meetings/workshops/child-obesity/index.htm).

Health care providers, which can include those directly in the clinical setting such as primary care physicians, nurse practitioners, dieticians as well as those individuals who may be part of the medical team but provide outreach to community resources and supports, such as community health workers (CHWs), are uniquely-positioned to help address overweight and obesity, particularly with respect to changing obesity-related behaviors among pediatric patients and their families (Nemet 2005). Support for the use of community-based, multi-disciplinary teams of health care providers to share the responsibility of delivering interventions in this area is clear (Goldstein 2004, Tulloch 2006). Interventions led by health care providers that target behavioral and lifestyle-changes can produce intended changes in risk behaviors among children (Ford 2002, Patrick 2006). Group counseling in children may be more cost-effective and feasible than individual counseling, and has been shown to elicit intended behavior change (Dreimane 2007, O’Connor 2008). Successful counseling initiatives often use patient self-monitoring, self-reward and goal-setting techniques; telephone, internet and mail-based strategies initiated by health care providers have also shown promise among children and adolescents (Saelens 2002, Patrick 2006). CHWs are lay workers based in the community who can play a role beyond the clinic setting by providing additional culturally appropriate counseling or assistance in navigating health care and community services and such as those provided by community agencies, schools, and public health clinics that can result in an augmentation of opportunities for physical activity and nutrition (National Assembly Policy Brief 2006 http://www.nationalassembly.org/fspc/documents/PolicyBriefs/Brief14.pdf, Rosenthal 2010, HRSA Workforce Study http://bhpr.hrsa.gov/healthworkforce/chw/). CHWs have effectively worked within communities to reduce health disparities and improve health outcomes associated with chronic diseases such as diabetes, cardiovascular disease, and asthma (Babamoto 2009, Postma 2009, Fedder 2003). Early evidence has shown that CHWs may be effective when working with families to promote healthful behaviors as a means to ameliorating the burden of childhood obesity (Ayala, 2010, Karanja 2010, Resnick 2009). Ayala et al. (2010) found that after two years, families receiving a promotora intervention focusing on nutrition and physical activity behaviors were more likely than controls to exhibit improvements in parental behaviors, such as controlling and monitoring; parental support; and parent-mediated family behaviors, such as purchasing away-from-home foods and TV watching during dinner time.

Recent initiatives that have included multiple-sectors with policy and environmental change have found promising results in the ability to reduce or stabilize child obesity (Economos et al., 2007, Economos and Curtatone, 2010). Therefore, based on the results of recent behavior change and/or obesity prevention and control interventions that have focused on one setting or level (Knai et al., 2006; The Community Guide), it is evident that a more robust approach is needed that focuses on policy, environmental, and systems approaches. These approaches integrate multiple settings and levels in support of children and their families to improve healthy eating and active living.

Current Research Opportunity

Section 401(a) of The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA, P.L. 111-3), added new section 1139A, to the Social Security Act (the Act). Subsection 1139A(e) of the Social Security Act requires the Secretary of Health and Human Services (HHS) to conduct a Childhood Obesity Demonstration Project (http://www.ssa.gov/OP_Home/ssact/title11/1139A.htm). In 2010, the Patient Protection and Affordable Care Act appropriated funding for the Project in section 4306.

These projects endeavor to develop a comprehensive and systematic model for reducing childhood obesity among children eligible for services under Titles XIX and XXI of the Social Security Act. Furthermore, these projects will seek to improve health care services delivery and utilization, health outcomes, quality of life and satisfaction among this eligible group of children and their families. This model should include approaches, systems, policies and tools for families to promote healthy behaviors in children by applying strategies using four key components: 1) health care systems and organizations, 2) community health workers, 3) pre-schools (child-care) and schools, and 4) communities.

The Obesity Chronic Care Model (http://content.healthaffairs.org/cgi/content/abstract/26/2/430 ) (Dietz 2007, Jacobson 2010) and other similar models should aid in designing proposals as part of an application. The Obesity Chronic Care Model is a synthesis of the attributes of the socio-ecological and chronic care models as applied to the prevention and reduction of obesity. The goal is to integrate primary care and public health approaches. The socio-ecological model describes the development of policies and interventions that occur due to actions and interactions across the individual, interpersonal, organizational, community and public policy spheres of influence. The socio-ecological model recognizes the interwoven relationship between individuals and their environment. The chronic care model describes health care for individuals with chronic conditions as taking place in three overlapping arenas: 1) the entire community and its resources and policies; 2) the health care system and payment structures; and 3) the health care provider organization, from large delivery systems to smaller clinics and practices. The Obesity Chronic Care Model is centered on patient self management, and links the environmental spheres, from the individual and family thorough the community and society, with the needed elements of the health system. Within this framework, interventions to improve obesity-related behaviors can be initiated in any setting, and the delivery of the relevant interventions by providers in the health care setting is augmented by policy and environmental changes at large.

In addition to utilizing the Obesity Chronic Care Model, applicants will use self-assessment modalities to identify (a) behavioral risk factors for obesity and (b) needed clinical preventive and screening benefits among identified children on the basis of risk factors. Ongoing support will be provided to identified children and their families to reduce risk factors and promote the appropriate use of preventive and screening benefits. Applicants will be required to design projects intended to improve health outcomes, satisfaction, quality of life, and appropriate use of items and services, including new approaches such as inclusion of community health workers as integral members of health teams or other innovative approaches that are appropriate within the context of the state, for which medical assistance is available under title XIX or title XXI among such target individuals. Additionally, applicants should assess changes in policies, systems and environments through the project design that can improve healthy lifestyles and behaviors in the target group of children and families. This may include strategies included in the CDC Recommended Community Strategies and Measurements to Prevent Obesity in the United States.

Applicants will be required to work across levels and sectors at the individual, family, organizational, and community levels to provide a range of coordinated interventions that include services, approaches, systems, tools, programs, and policies across multiple sectors related to reducing childhood obesity. Applicants must draw upon promising, innovate models to develop these interventions. These services and interventions must include community-based activities; childcare and school-based activities; providing screening, educational, counseling activities through the local health care delivery system. Applicants are encouraged to collaborate with providers serving Medicaid/CHIP enrollees. The community-wide consortium should include partners from the multiple sectors with linkages to relevant members across the community who are working towards policy and environmental changes including available healthy food and physical activity in the community and youth settings. Useful tools that can be employed by local consortia/collaborative can be found in toolboxes like the one found in the web site http://ctb.ku.edu/en/tablecontents/chapter_1003.aspx.

This project will be expected to work in concert and demonstrate linkage with current federal efforts addressing childhood obesity prevention and reduction that are already present in the community, including those noted in the White House Task Force on Childhood Obesity Report. Examples of these federal efforts include those occurring through current CDC supported state programs including the Nutrition, Physical Activity and Obesity State program (http://www.cdc.gov/obesity/stateprograms/index.html), CDC supported community programs such as Healthy Communities (http://www.cdc.gov/healthycommunitiesprogram/), The Racial and Ethnic Approaches to Community Health (REACH) (http://www.cdc.gov/reach/) and the recently American Recovery and Reinvestment Act (ARRA) Communities Putting Prevention to Work (CPPW) State, Territorial, Tribal and Community programs administered through the CDC, programs of the Department of Education and United States Department of Agriculture, and the Healthy Weight Collaborative initiative administered through the Human Resources and Services Administration (HRSA). Initiated in 2010, CPPW funds more than 45 communities and all 50 states to change food and physical activity environments, particularly through the use of policy. Many of these programs are working to improve the child care and school nutrition and physical activity environments (http://www.cdc.gov/CommunitiesPuttingPreventiontoWork/). The Healthy Weight Collaborative of HRSA was funded in 2010 to share evidence-based and promising community-level and clinical interventions to prevent and treat obesity. Through the Healthy Weight Collaborative, collaborative teams are being recruited to help states and local communities develop practical approaches that link public health and primary care. Furthermore, HHS recently announced the first in a series of awards under the Affordable Care Act designed to address pressing construction and renovation needs in community health centers across the country and expand access to quality health care. Efforts are underway to improve the infrastructure, expertise and services needed to improve health care across the country. The Center for Medicare & Medicaid Services (CMS) expects to issue future guidance to program directors on State Medicaid and CHIP coverage and reimbursement for childhood obesity related services.

In addition to working in concert with these other federal efforts, this project could complement non-governmental efforts, augmenting state obesity task force activities and initiatives like the Robert Wood Johnson Foundation’s Healthy Kids, Healthy Communities initiative (http://www.rwjf.org/childhoodobesity/pg.jsp) and the work of state and community Food Policy Councils and Community Coalitions (http://www.foodsecurity.org/).

This research demonstration project is an opportunity to evaluate whether benefits covered under titles XIX (Medicaid) and XXI (CHIP) of the Social Security Act are having an impact on improving parenting strategies, parent modeling, and child health outcomes, such as quality of life and changes in obesity related behaviors such as nutrition (increase fruit and vegetables, decrease sugar drinks, decrease energy dense food consumption), screen time/television viewing, and sleep and physical activity. To augment and sustain improved health outcomes, appropriate and effective interventions in community settings (e.g., childcare, school), and at different levels (e.g., family, community organizations) are needed to prevent and reduce not only behavioral, but also environmental risk factors for obesity as suggested by the Expert Committee Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity. This approach supports the recruitment and engagement of parents and other influential adults as "change agents" within and outside of the family. These individuals interact with the child in diverse settings that span the continuum of childhood activities and safe environments in concert with changes in policies, environments and best practices in child care, schools and communities (e.g. such as improving safe physical activity in neighborhood parks, recreation centers) that reinforce and complement efforts to increase fruit and vegetable consumption and physical activity and decrease passive screen time, consumption of high energy dense foods and sugary beverages.

Scientific Knowledge to be Achieved through this Funding Opportunity

The objective of the demonstrations is to determine whether an integrated model of primary care and public health approaches in the community such as policy, systems, and environmental supports for nutrition and physical activity can improve underserved children’s risk factors for obesity. This includes changes in factors such as improved parenting skills, reduced childhood obesity risk factors such as improved physical activity, sleep, fruit and vegetable intake, reduced television and screentime viewing, high energy dense foods and sugar drink consumption, improved utilization of preventive services such as screening and counseling, improved satisfaction with health care services provided by Federally qualified health centers and other primary care providers in the community, and improved quality of life.

The research demonstration projects and accompanying overarching evaluation supported by this FOA are expected to generate knowledge that can be translated into models that can be developed, implemented, sustained and brought to scale to benefit the general population of children who are eligible for child health insurance assistance under State Children’s Health Insurance Programs (CHIP). The demonstration should draw upon promising, innovative models and incentives to reduce behavioral risk factors. The purpose is to utilize what is learned from these demonstration projects to implement similar cost-effective programs or program components to improve health outcomes for underserved children including obesity-related nutrition and physical activity behaviors, improve health care services delivery and utilization, quality of life and satisfaction.

Funded childhood obesity prevention and reduction demonstration projects should:

· Ensure delivery of appropriate primary care preventive services to underserved children including where possible inclusion and collaboration with medical providers serving Medicaid/CHIP enrollees.

· Focus on underserved families of children aged 2 to 12 to improve parenting strategies, parent modeling, and children’s behavioral risk factors.

· Provide educational, counseling, promotional, training and outreach efforts to families through the local health care delivery systems. These efforts should utilize multidisciplinary health care teams.

· Include community health workers as members of the health teams and should be trained through and supervised by qualified health professionals to deliver appropriate educational and counseling efforts. Community health workers can also facilitate linking families and their children to appropriate community resources and can work toward healthy community development.

· Identify and integrate into the project design school, child care, and community activities including policy, environmental, and systems change approaches that have sustainability.

· Identify and build upon existing community, regional and state resources, relationships and assets.

· Ensure consistent messaging across the interventions.

Research Objectives and Approach

NOTE

This is not a capacity development cooperative agreement. Successful applicants must have the capacity in place to rapidly initiate the demonstration, sustain systems and policy changes, and to participate in the evaluation of its effectiveness (reach, coverage, adoption of new provider and family behaviors, changes in service utilization, etc.). Evidence of this capacity will be used to confirm eligibility (see Section III. Eligibility Information, 4. Additional Information on Eligibility). Also, Pre-decisional Site Visits will be conducted by CDC to validate the readiness of applicants and their communities to participate in this research demonstration.

This FOA Has Two Components, A and B: Applicants must specify which Component they are applying. Component A solicits applications to participate as a Demonstration Project. Component B solicits applications to serve as the third-party evaluator (the Evaluation Center) that will collaborate with CDC and the participating Demonstration Projects in all aspects of the overarching evaluation of all the research demonstration projects. Applicants may apply for either Component A or Component B, but not both.

As outlined in the Children’s Health Insurance Program Reauthorization Act, successful applicants are those: (A) that demonstrate that they have previously applied successfully for funds to carry out activities that seek to promote individual and community health and to prevent the incidence of chronic disease and that can cite published and peer-reviewed research demonstrating that the activities that the entities propose to carry out with funds made available under the grant are effective; (B) that will carry out programs or activities that seek to accomplish a goal or goals set by the State in the Healthy People 2010 plan of the State; (C) that provide non-Federal contributions, either in cash or in-kind, to the costs of funding activities under the grants; (D) that develop comprehensive plans that include a strategy for extending program activities developed under grants in the years following the fiscal years for which they receive grants under this subsection; (E) located in communities that are medically underserved, as determined by the Secretary; (F) located in areas in which the average poverty rate is up to 150 percent of the average poverty rate in the State involved, as determined by the Secretary; and (G) that submit plans that exhibit multi-sectoral, cooperative conduct that includes the involvement of a broad range of stakeholders, including—

(i) community-based organizations; (ii) local governments; (iii) local educational agencies; (iv) the private sector; (v) State or local departments of health; (vi) accredited colleges, universities, and community colleges; (vii) health care providers; (viii) State and local departments of transportation and city planning; and (ix) other entities determined appropriate by the Secretary.

Research Demonstration Project Plan and Objectives (Component A):

Successful applicants who will receive awards are expected to:

1. Provide a plan for their intervention program approach developed with the involvement of key sector and community stakeholders, which identifies current gaps, barriers, and opportunities through a community assessment, as well as current child and family attitudes and behavioral risk factors.

2. Project design should utilize the Obesity Chronic Care Model and include:

a. A definition of eligible participants in the study focusing on underserved children aged 2-12 years with adequate power to detect changes in utilization, behavior and satisfaction, over the period of intervention. Describe and address the obesity-related burden and associated risk factors in the proposed intervention population.

b. Critical information about community assets and needs, and a plan to complete a comprehensive Community Assessment that will fill information gaps.

c. The design of a multi-sectoral and multi-level intervention strategy.

d. A preliminary site-specific evaluation research design and protocol with the expectation of collaboration and revision of preliminary research plan with other demonstration project sites, evaluation center, and CDC to ensure common evaluation measures across sites, and plans for finalizing evaluation methods, and obtaining appropriate approvals (e.g., IRB).

e. A plan for sustaining the intervention or specific intervention components post-evaluation, and expanding it beyond the demonstration catchment area. The former, if it entails adding, altering or augmenting basic covered services, would need a request to CMS for approval. This could also include examples of non-financial commitment and agreement from their state Medicaid/CHIP agency and contracting insurers who work with the state to deliver CHIP.

3. Design and implement a plan for linking levels and sectors, including, but not limited to communications, referrals, and reporting.

4. Design and implement a project that is intended to assess measurable changes in risk factors for obesity and improved outcomes including:

a. Identifying, through self-assessment (self-report by child and/or caregiver), behavioral risk factors for obesity among children;

b. Identifying, through self-assessment, needed clinical preventive and screening benefits among those children identified as target individuals on the basis of such risk factors;

c. Providing ongoing support to such target individuals and their families to reduce risk factors and promote the appropriate use of preventive and screening benefits; and

d. Improving health outcomes, satisfaction, quality of life, and appropriate use of items and services for which medical assistance is available under title XIX or title XXI among such target individuals;

e. Improving policies, systems and environmental changes to promote healthy lifestyles and behaviors among the target group of children and their families.

5. Implement the demonstration project:

a. Lead and coordinate the consortium or coalition as it implements the intervention.

b. Collect and analyze baseline, interim, and follow-up data using common measures (across demonstration sites) that can be used to measure expected changes in behaviors and weight and to support recommendations and reporting about the intervention. (More specific outcome measures are described in the section below, Research Plan Components, Component A, (h) Evaluation Research Design.)

6. In collaboration with the Evaluation Center and CDC, contribute to the overall evaluation of this initiative by:

a. Collecting and sharing demonstration project process and outcome data with the Evaluation Center.

b. Plan and conduct cost evaluations, or cost-effectiveness analyses, as a joint activity of the demonstration sites and the evaluation center, in consultation with CDC. Metrics relevant to cost and effectiveness will be part of the common protocol for both site-specific analyses as well as overarching analyses across the three sites.

c. Capturing and documenting lessons learned, including, but not limited to practical keys to sustainability and local or state scalability based on documented experience that can inform national implementation.

d. Preparing actionable recommendations as to whether the demonstration project or components should be continued and, if so, how it could be sustained locally or expanded to other communities.

e. Developing guidelines for transferring lessons learned to other communities.

Timeline (Component A):

Phase 1: Start-up (Months 1-12).

In collaboration with the Evaluation Center and CDC:

a. Complete the Community Assessment so that gaps in information are filled, and use the results to inform project design.

b. Finalize the intervention design with partners and stakeholders.

c. Work with the Evaluation Center and CDC to finalize overarching evaluation questions, the evaluation research design for the overarching evaluation and the demonstration project evaluation, finalize cross-grantee indicators and data collection instruments in support of measurable outcomes and for the overarching evaluation, and a coordinated work plan and timeline.

d. Complete the study participant recruitment and retention plan.

e. Train community health workers.

f. Establish infrastructure and system for coordination between levels and sectors, including, but not limited to communications, referrals, and reporting.

g. Finalize the work plan (timeline, clarification of responsibilities, milestones, reporting).

Phase 2: Intervention Implementation (Baseline, Interim, and Follow-Up Data Collection) (Months 13-36)

Phase 3: Finalize data collection, Work with Evaluation Center on the Evaluation and Reports, Assess Sustainability, Use results to strengthen the program (Months 37-48)

a. Finalize local demonstration project data analysis, interpretation of findings, development of local recommendations for strengthening the intervention, and lessons learned that can be used to guide interventions in other communities.

b. Participate in the final analysis of data, interpretation of findings, and preparation of recommendations related to the overarching evaluation.

c. Use evaluation findings and recommendations to strengthen and sustain the intervention program.

d. Provide the Evaluation Center with assistance in scheduling post-intervention implementation interviews.

Evaluation Center Research Objectives (Component B):

The successful applicant is expected to:

1. Assist in the design of common community assessment methods and tools for use by each demonstration project community (e.g., CDC Recommended Community Strategies and Measurements to Prevent Obesity in the United States).

2. Design and implement an overall evaluation plan that determines whether programs similar to the awarded demonstration projects should be implemented nationally for children in diverse communities who are eligible for services under Title XXI. The overall evaluation plan should be consistent with that of an impact evaluation design.

3. Collaborate with demonstration projects and CDC to develop and coordinate community-specific evaluation protocols to systematically assess the effectiveness of the research demonstration projects, separately and across projects.

4. Serve as an evaluation research data repository for the overall evaluation of this initiative and the demonstration projects’ evaluations.

5. Compile and analyze data; distill evaluation research findings; and interpret these findings to support (1) national policy decision-making and (2) local community decision-making to solidify, sustain, and expand the program.

6. Produce interim progress reports to update demonstration project staff, CDC, and others.

7. Produce a final evaluation report that incorporates the results of the overall evaluation research and the demonstration projects and provides detailed analysis on health outcome changes, specifically changes in BMI.

Timeline (Component B)

Phase 1: Evaluation Research Design, Coordination, and Infrastructure (Months 1-12)

1. In collaboration with funded Demonstration Projects and CDC:

a. Clarify roles, responsibilities, timelines, and contributions of all parties with respect to the evaluation research for the overall initiative and the demonstration projects.

b. Finalize the data collection plan and instruments and obtain approvals (e.g., IRB).

c. Collect and/or support the collection of data and information in demonstration project communities.

d. Finalize the design and start implementing the evaluation research plan for the overall initiative.

e. Prepare for and begin functioning as the Evaluation Research Data Repository.

Phase 2: Evaluation Research Data Collection, Analysis, Preliminary Findings, and Use of those Findings Locally (Months 13-36)

In collaboration with the Demonstration Projects, and in consultation with CDC:

Complete the process and outcome evaluation including health outcomes such as quantifiable changes in behavior and weight outcomes, and cost- effectiveness, cost savings, and scalability analyses. (More specific outcome measures are described in the section below, Research Plan Components, Component A, (h) Evaluation Research Design.)

Phase 3: Finalize data collection, the overarching evaluation and produce reports, including assessments of sustainability and scalability (Months 37-48)

a. Finalize data aggregation and synthesis incorporating data and information from all demonstration sites.

b. Conduct post-intervention key informant interviews in each demonstration project community.

c. Lead the process of interpreting findings, developing recommendations, and incorporating what has been learned into draft guidelines for policy makers and communities.

NOTE:

Provide a detailed design, work plan, and timeline in Section IV, Research Plan Components.

References

Ayala, G.X., et al., Longitudinal intervention effects on parenting of the Aventuras para Ninos study. Am J Prev Med 2010; 38(2): 154-62. Retrieved from http://www.ajpm-online.net/article/S0749-3797(09)00748-X/abstract Babamoto KS, Sey KA, Camilleri AJ, et al. Improving diabetes care and health measures among hispanics using community health workers: results from a randomized controlled trial. Health Educ Behav 2009; 36(1): p. 113-26. Retrieved from http://heb.sagepub.com/content/36/1/113.abstract 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-S192. Retrieved from http://pediatrics.aappublications.org/cgi/content/abstract/120/Supplement_4/S164 CDC. Communities Putting Prevention to Work (CPPW).