Jennie Hill, PhD Kate Heelan (MPI) , PhD University of Nebraska Kearney

1. Engaging communities across a variety of implementation strategies to address rural childhood obesity treatment Jennie Hill, PhD Kate Heelan(MPI) , PhD University of Nebraska Kearney Co-I’s: Paul Estabrooks, Todd Bartee, Bryce Abbey, Tzeyu Michaud, Chris Wichman Supported by CDC 1 U18DP006431-01-00 (Hill/Heelan MPI)

2. Key Ingredients for Successful D&I Grants: The Nebraska CORD 3.0 Project

3. CDC’s Childhood Obesity Research Demonstration Project 3.0 • Focus on adapting, testing, and packaging effective programs to reduce childhood obesity among children from lower-income families. • Examining sustainable and cost-effectiveness in multiple settings. • Develop user-friendly, “packaged” materials and messages for healthcare, community, or public health organizations • Increase the availability of effective pediatric weight management interventions for millions of children from lower-income families.

4. Nebraska Cord 3.0 • Grant Aims • Collaboratively refine and develop a family-based childhood obesity intervention package that includes all of the materials necessary for others to implement the intervention in new micropolitan and rural locations.

5. Nebraska Cord 3.0 • Grant Aims • 2. To perform a rigorous, mixed-methods pilot dissemination and implementation research study • community application process to identify 4 to 8 new communities to pilot test the program and training materials • use a learning collaborative facilitation strategy and sustainability action planning process to support program adoption, implementation, and sustainability • Comparison—packaged program alone with minimal • technical assistance. • Other outcomes: cost, reach, representativeness, and effectiveness relative to a matched cohort.

6. Nebraska Cord 3.0 • Grant Aims • 3. To use the pilot evaluation data and results of the sustainability action plan to refine program and training materials and develop a dissemination plan to move the program to other communities.

7. 4 1 Rural and Micropolitan Communities that Provide Services to Low-Income Families • Eligibility Criteria: • Document providing services for low income families • Systems-based multi-sectoral partnership with representation of partners to complete screen and engagement as well as partners to implement the PWMI. • Systems-based vertical representation • Commitment to implement PWMI to 3 cohorts of families over 2 years • Commitment to use pragmatic evaluation strategies for specific RE-AIM outcomes • Commitment to completing a sustainability action plan 2 Letter of Interest to Implement PWMI Implementation Pilot Aim 1 To determine if funding and contracting for PWMI delivery, obtaining formal commitments from community organizations, and promoting network weaving will provide information on PWMI demand and lead to the adoption of the PWMI. Implementation Strategy 3: Sustainability Action Planning with Payer Stakeholders Dissemination Strategy 3: School and clinical systems approaches to improve intervention reach Dissemination Strategy 1: Packaging the evidence-based approach for easy uptake in small towns and Rural Communities Implementation Strategy 1: Systems-based learning collaborative Implementation Strategy 2: Consultee centered training approach w/in learning collaborative Dissemination Strategy 2: Identify community systems with potential for implementation 3 Request for Applications 5 6 Half of Successful Applicants (No less than 2, no more than 4) Half of Successful Applicants (No less than 2, no more than 4) 9 Criteria For Communities to Use Resources: Willingness to sign a memorandum of understanding and provide de-identified program data for baseline, 6, and 12 months Implementation Pilot Aim 2 To determine if a learning collaborative implementation strategy is more successful in promoting PWMI adoption, delivery fidelity, and sustainability over a 2 year period—when compared to community access to the PWMI packaged materials alone. 8 7 Access to Resources Plus Learning Collaborative with embedded Consultee-Centered Implementation Strategy (up to n=4) Access to Packaged PWMI Training and Program Resources Only (up to n=4) 10 Initiate 3-Step Sustainability Action Planning Process: Sustainability needs assessment. Examine resources to deliver the PWMI; identify potential adaptations for sustainability while adhering to the PWMI core components. Develop sustainability action 13 Track adoption, Implementation fidelity, and intent to sustain the PWMI over 2 years (n=) 12 Track adoption, Implementation fidelity, and intent to sustain the PWMI over 2 years (n=3 Cohorts proposed/community) 14 Self-Report PWMI Implementation Fidelity Assessment 11 Objective and Self-Report PWMI Implementation Fidelity Assessment Participant Formative Evaluation 16 17 Evaluate Program Reach and Effectiveness of Cohort Participants at BL, 6, and 12 months Evaluate Program Reach and Effectiveness in Reducing BMI% for each Cohort at BL, 6, and 12 months 15 Develop matched cohort for comparison of BMI% changes through BMI report card or clinical data at BL, 12, 24 months Implementation Pilot Secondary Aims To determine the reach effectiveness, and maintenance of the implemented PWMIs

8. Outcomes 4 1 Rural and Micropolitan Communities that Provide Services to Low-Income Families • Eligibility Criteria: • Document providing services for low income families • Systems-based multi-sectoral partnership with representation of partners to complete screen and engagement as well as partners to implement the PWMI. • Systems-based vertical representation • Commitment to implement PWMI to 3 cohorts of families over 2 years • Commitment to use pragmatic evaluation strategies for specific RE-AIM outcomes • Commitment to completing a sustainability action plan 2 Letter of Interest to Implement PWMI Implementation Pilot Aim 1 To determine if funding and contracting for PWMI delivery, obtaining formal commitments from community organizations, and promoting network weaving will provide information on PWMI demand and lead to the adoption of the PWMI. Implementation Strategy 3: Intervention Maintenance (operationalized as delivery to a 3rd cohort) Dissemination Strategy 1: Adoption—number and representativeness of communities Dissemination Strategy 2: Adoption—number and representativeness of communities Implementation Strategy 1: Implementation Quality Fidelity/competence Implementation Strategy 2: Implementation Quality Fidelity/competence Dissemination Strategy 3: Reach—number and representativeness of families in evidence-based intervention 3 Request for Applications 5 6 Half of Successful Applicants (No less than 2, no more than 4) Half of Successful Applicants (No less than 2, no more than 4) 9 Criteria For Communities to Use Resources: Willingness to sign a memorandum of understanding and provide de-identified program data for baseline, 6, and 12 months Implementation Pilot Aim 2 To determine if a learning collaborative implementation strategy is more successful in promoting PWMI adoption, delivery fidelity, and sustainability over a 2 year period—when compared to community access to the PWMI packaged materials alone. 8 7 Access to Resources Plus Learning Collaborative with embedded Consultee-Centered Implementation Strategy (up to n=4) Access to Packaged PWMI Training and Program Resources Only (up to n=4) 10 Initiate 3-Step Sustainability Action Planning Process: Sustainability needs assessment. Examine resources to deliver the PWMI; identify potential adaptations for sustainability while adhering to the PWMI core components. Develop sustainability action 13 Track adoption, Implementation fidelity, and intent to sustain the PWMI over 2 years (n=) 12 Track adoption, Implementation fidelity, and intent to sustain the PWMI over 2 years (n=3 Cohorts proposed/community) 14 Self-Report PWMI Implementation Fidelity Assessment 11 Objective and Self-Report PWMI Implementation Fidelity Assessment Participant Formative Evaluation 16 17 Evaluate Program Reach and Effectiveness of Cohort Participants at BL, 6, and 12 months Evaluate Program Reach and Effectiveness in Reducing BMI% for each Cohort at BL, 6, and 12 months 15 Develop matched cohort for comparison of BMI% changes through BMI report card or clinical data at BL, 12, 24 months Implementation Pilot Secondary Aims To determine the reach effectiveness, and maintenance of the implemented PWMIs

9. 1. Identify the quality gap… what is and what could be Since the early 1980s, a number of efficacious pediatric weight management interventions (PWMI) have been developed to reduce child weight status. The majority of efficacious PWMI have been based in large urban areas delivered through hospitals or medical center The most recent childhood obesity treatment recommendations do not address geographically underserved settings where all members of an interdisciplinary team may not exist The prevalence of obesity is higher in rural areas while socioeconomic status and access to healthcare is lower

10. 2. Evidence-based interventions to be implemented? Epstein’s Traffic Light Eating Plan is likely the most studied pediatric weight management intervention and has demonstrated efficacy across a wide range of randomized controlled trials in children 6-12 years of age. Building Healthy Families is an adaptation of Epsteins’ work and has been implemented in Kearney Nebraska for over 10 years with annual cohorts of families participating.

11. Building Healthy Families • What is it? • Weight loss program consisting of physical activity, nutrition education, and behavior modification • 12 sessions • Assessments at baseline and 12 weeks • Relapse prevention and follow-up at 6 months and 1 year • Weekly 2 hour time commitment • Family-based program

12. Changes in Body Composition Child Participants BMI z-score reduction, on average at 0.27. This BMI z-score reduction is consistent with PWMI efficacy studies

13. 3. Conceptual model/ theoretical framework --Reach (families) --Effectiveness (family outcomes) --Adoption (community uptake) --Implementation (community facilitator fidelity and competence) --Maintenance (program sustainability) RE-AIM planning and evaluation framework

14. 3. Conceptual model/ theoretical framework Improve perceptions of evidence Relative advantage, compatibility, trialability, complexity, observability, and cost of BHF Improve community and organizational contextual factors Leadership and organizational readiness to change Develop facilitation infrastructure for quality implementation Leadership, champion, and staff commitment for implementation Promoting Action on Research in Health Services (PARiHS)

15. 4. Stakeholder priorities, engagement in change & study Great Plains IDeA Clinical and Translational Research Network Community Advisory Board (IDeA-CTR CAB) Building Healthy Families (BHF) Community Advisory Board (BHF-CAB) BHF Learning Collaborative (BHF-LC) Payer Advisory Subcommittee (PAY-SUB) Participatory structures built into the proposal

16. Review the implementation pilot project across the initiation, implementation, and completion phases during their semi-annual day-long CAB meetings. Help with engaging state departments of health across the region Contribute to our payer and sustainability advisory subcommittee Assist in developing a dissemination plan to take the program to scale across other communities. IDeA-CTR CAB

17. This CAB will provide guidance and feedback to the research team across all aims of the project. Meet in person quarterly, and in between as needed to address questions Membership: UNK/UNMC and original community partners-clinicians, school officials, the dietitian, and behavioral specialist. Parent participant, the Director of the Office of Public Health Practice, local public health officials, the medical director of the Nebraska Medicaid & Longterm Care Division and a representative from the GP IDeA-CTR CAB. BHF-Community Advisory Board (BHF- CAB)

18. Convened for the implementation trial Communities selected for the implementation trial will be required to send multi-sector teams to participate in the BHF-LC. The academic team will develop content for LC, focused on increasing capacity among communities to successful adopt, implement and deliver the program The LC will participate in sustainability planning and in the development of a dissemination plan group BHF-Learning Collaborative (BHF--LC)

19. End of year 3, years 4-5 A subcommittee of the BHF-CAB with additional members of ‘payers’ and representatives from other organizations that could contribute to identifying and securing potential avenues for reimbursement and long-term sustainability. Will contribute to sustainability action planning and development of the dissemination plan (how communities can sustain and cover program costs). BHF-Payer Sub

20. 5. Setting’s readiness to adopt new intervention Addressed this in the proposal by including letters of support from potential communities In the implementation trial, this is addressed by assessing readiness of communities that submit LOI

21. 6. Implementation strategy/process Learning Collaborative: a structured way for organizations with common interests to close the gap between potential and practice by learning from each other Learning collaboratives as an implementation strategy

22. Evidence for Learning Collaboratives as an implementation strategy: Systematic reviews that find LC are effective in changing provider behavior; however little evidence that LC change outcomes at the patient-level Nadeem et al. tackle the ‘components’ of learning collaboratives that lead to a change in outcomes

23. Leadership Group Established Plan Leadership group sets agenda, decides on LC • Outcomes: • Leadership Group Evaluates & Improves • Teams sustain & spread Prework Learning Sessions/Action Periods Figure 2. Overview of Action Learning Collaborative (LC) Framework PDSA Cycle Action Periods include activities related to implementation pilot study and are supported by the BHF-CAB including research partners; examples include proactive outreach, zoom/conference calls, goal setting and feedback for LC participants

26. 7. Team experience w/ setting, treatment, implementation

27. Building Healthy Families Kearney Staff • Physical Activity Coordinator • KSS Dept Faculty • Program Coordinator • Dr. Bryce Abbey • Community Outreach Coordinator • Dr. Todd Bartee • Program Directors • Dr. Kate Heelan Professor/ Director (UNK) • Dr. Nancy Foster Behavioral Psychologist (Munroe-Meyer Institute/UNMC) • Kaiti George, RD, LMNT Dietitian (HyVee) • Medical Director and Pediatrician • Dr. Angie Kratovil-Stava

28. Trifoia-- is a full service instructional design, media production, and e-learning technology integration company. With more than 20 years’ experience developing media-driven curriculum. Trifoia team will provide instructional design, graphic design, video production, and custom internet-based e-learning development and implementation.

29. 8. Feasibility of proposed research design & methods • Preliminary Studies K2A PWMI Translation in Nebraska: Adaptation of Epstein’s Traffic Light Eating Plan Documentation of adaptation outcomes-changes in weight, body comp, etc Clinical and school (e.g. BMI report card) as a screening pathways to populate program Expansion efforts Estabrooks & Hill experience with adapting PWMI in Virginia: iChoose-adaption of a family based pediatric weight management program Community-engaged approaches in rural communities Models for training local community organizations to implement and deliver the program with fidelity

30. 9. Measurement and analysis detail • Type 3 HEI Trial • HEI Primary Aims 1 & 2: Implementation fidelity will be analyzed using descriptive statistics and reported as proportion of intervention delivered as intended for the referral strategies and BHF implementation. In each case the PWMI will be considered by component (e.g., referral strategies (1) family identification process, (2) family outreach letters, (3) proactive outreach call, (4) enrollment process, (5) class content). • Power calculation for the BHF effectiveness (BMI z-score) using 6-months data point; 2 cohorts of families per community with an option for a 3rd cohort • Match cohort for comparison, using BMI reporter data

31. 10. Policy environment will support/sustain the change • Long-term sustainability • Packaged BHF program will be a robust, self-contained facilitator training platform • Community-based organizations that have teams in place or willing to build these teams to adopt and deliver the program • Sustainability planning as part of the BHF-LC • Payer subcommittee: role is to help identify payment pathways for ongoing sustainability in communities