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. 2021 Sep 24;17(Suppl 1):S-22–S-29. doi: 10.1089/chi.2021.0172

Implementation of the JOIN for ME Program for Families from Low-Income Backgrounds: The Use of Theory-Driven Formative Evaluation: Rhode Island CORD 3.0

Katherine E Darling 1,2,✉, Jacqueline F Hayes 1,2, E Whitney Evans 1,2, Ronald Seifer 3, A Rani Elwy 2,4, Elissa Jelalian 1,2
PMCID: PMC8574201  PMID: 34569847

Abstract

Advances have been made in the development of effective interventions to address pediatric obesity; however, research findings often do not translate into clinical practice and a limited number of programs have been designed toward wide-spread dissemination and implementation. The Rhode Island (RI)-Childhood Obesity Research Demonstration (CORD) 3.0 Project involves adapting and testing an evidence-based pediatric weight management intervention (PWMI), JOIN for ME, for wide-scale dissemination and implementation in communities with a high proportion of families from low-income backgrounds. In this article, we describe the robust developmental formative evaluation (FE) process employed by RI-CORD as a model for the use of FE to drive dissemination of evidence-based PWMIs. The current project was guided by the Consolidated Framework for Implementation Research and Proctor Implementation Outcomes. This article also showcases examples of how the use of key informant interviews from engaged stakeholders in the community during a developmental FE process can drive selection of implementation strategies. The use of FE, driven by evidence-based theory, can help provide a roadmap to successful implementation of a pediatric weight management program, such as JOIN for ME.

Keywords: dissemination, formative evaluation, implementation, pediatric obesity, pediatric weight management intervention

Given the alarmingly high rate of children with overweight and obesity, obesity during childhood is a significant public health concern in the United States.1 Childhood obesity is associated with both negative physical (e.g., hypertension, type 2 diabetes mellitus) and psychosocial outcomes (e.g., lower quality of life, depression).2 The prevalence of obesity among children from low-income backgrounds is nearly twice that of their peers from higher income households.3,4 Despite this disparity,5 children and families from low-income backgrounds are less likely to have access to and succeed in pediatric weight management interventions (PWMIs) compared with peers from higher income backgrounds.6,7 Furthermore, obesity in children from low-income backgrounds is often not addressed in a timely manner, if at all, and leads to worse health outcomes.8–10 A significant need exists for an evidence-based intervention that provides equitable access to children from low-income backgrounds.

Dissemination Efforts in Pediatric Obesity

Although advances have been made in the development of effective family-based interventions to address pediatric obesity, a limited number of programs have been designed with treatment dissemination in mind11–14 and research findings are often not translated into clinical practice.15 Dissemination is an active approach that involves spreading evidence-based interventions to a target audience using planned strategies.16 Specific implementation strategies are necessary given that passive approaches are widely ineffective.17 Specifically, strategies that address barriers and facilitators to improve the uptake of an effective intervention can ultimately lead to successful dissemination in a routine setting.16 Implementation strategies are the “methods or techniques used to enhance the adoption, implementation, and sustainability of a clinical program or practice,”18 with 73 evidence-based implementation strategies identified from previous literature and an expert panel.19 Broadly, dissemination and implementation approaches include using multilevel messages to reach specific audiences, involvement of stakeholders in intervention efforts from the beginning, integration of theory and frameworks, and tailoring dissemination efforts to a specific audience are likely to lead to a successfully disseminated intervention.17 Capitalizing on the principles of dissemination and implementation science provides a strong approach for effectively translating effective PWMIs into community settings and improving access for the most at-risk children.16

An additional issue relevant to increasing equitable access to PWMIs is that, of the few programs that have been successfully implemented and disseminated across community settings,13,20,21 none have specifically focused on children and families from low-income backgrounds. A focus on translating interventions explicitly for this population is crucial in reducing the obesity-related disparities experienced by children from families with limited means. Recent articles highlight the dangers of not considering important social determinants of health, such as income or race, in designing and disseminating evidence-based interventions.22,23 This includes improving health of general populations, but not effectively reaching populations who may be most in need, ultimately widening existing disparities. Kumanyika provides evidence of this phenomenon occurring within pediatric obesity prevention interventions, with high-risk demographic groups not seeing the same benefits in diet and physical activity improvements as more privileged groups of children.24

One key recommendation to combat health inequities within interventions implemented into real-world settings includes giving adequate consideration to the contexts in which the intervention will be implemented.22,23 This can occur through the formation of strategic and collaborative partnerships with organizations and stakeholders outside traditional health settings, such as housing or transportation. Leveraging and building on these existing community resources, including sharing decision making, can support uptake, effectiveness, and sustainability of interventions, such as the JOIN for ME program, in communities most at risk.

Rhode Island: Childhood Obesity Research Demonstration 3.0

The goal of the CDC Childhood Obesity Research Demonstration (CORD) 3.0 projects is to implement evidence-based PWMIs in communities with diverse populations and those with a high proportion of families from low-income backgrounds.25 The Rhode Island (RI)-CORD 3.0 project involves adapting and testing JOIN for ME for wide-scale community-based dissemination and implementation. The JOIN for ME program was initially developed as a collaboration between YMCA of the United States and UnitedHealth Group as a scalable intervention informed by principles of effective family-based behavioral weight control that can be embedded into established organizations.26 JOIN for ME is a 10-month intervention (16 weekly sessions, moving to bi-weekly and then monthly sessions; 30 hours total) with caregiver–child dyads participating in the intervention simultaneously to address overweight and obesity in children. Designed to be delivered in community-based settings with treatment materials available in English and Spanish, JOIN for ME is effective in reducing percentage overweight in children of ages 6–12 years.26

Following principles of dissemination and implementation science, it is vital to integrate interventions such as JOIN for ME into community-based settings that can reach populations most in need of the intervention. Furthermore, it is critical to determine the optimal strategies for adapting and delivering these programs in an equitable and sustainable manner.22 Two articles in this special issue of the CORD 3.0 projects discuss the dissemination and implementation of the JOIN for ME program in community settings, specifically for delivery by community health workers in municipal housing authorities and federally qualified health centers. The first by Jelalian and colleagues describes the study protocol and intervention. The current article outlines the dissemination and implementation practices used to facilitate the implementation of JOIN for ME for children from low-income backgrounds in housing authorities and federally qualified health centers. Specifically, a robust developmental formative evaluation (FE) process that involved interviews with stakeholders and focus groups with parents and children from the populations of interest was conducted.

Qualitative interviews with key stakeholders focused on understanding how best to engage with the community to improve implementation outcomes. Specifically, key stakeholders were asked about the organization's ability to engage in evidence-based practices, family's perceived acceptability, appropriateness, feasibility of the intervention, efforts to increase uptake of the intervention in new settings, and the role of community health workers in delivering the intervention. During focus groups, children and caregivers were asked to provide feedback on specific intervention components to elicit feedback on relevance, accessibility, language, images, and activities to drive curriculum adaptation.

The present article provides sample quotes from the key stakeholder interviews in the RI-CORD 3.0 implementation of the JOIN for ME program to showcase how stakeholder engagement within the context of FE can be used to drive the selection of implementation strategies. Stakeholder interviews were guided by the Consolidated Framework for Implementation Research (CFIR) and the Proctor Implementation Outcomes Framework. The frameworks were chosen to allow our team to identify specific determinants (barriers and facilitators) of implementing JOIN for ME in housing and health care settings. Understanding the barriers and facilitators enables the identification and use of specific implementation strategies to increase acceptability, feasibility, and uptake of the intervention from the outset of the project. The concept of FE and the principles and evidence base for the CFIR and Proctor frameworks, as well as how they guided the initial stages of this project, are described hereunder. Examples are provided within this article to illustrate the potential of FE guided by theoretical frameworks (i.e., CFIR, Proctor) to inform implementation efforts for pediatric weight management.

Formative Evaluation

FE is an assessment process that identifies potential and actual influences on implementation efforts.27 FE is a continuous process across the course of an implementation effort to identify modifications that will ultimately improve implementation success and generalizability as well as document the implementation process.28 FE may be particularly important when the implementation project involves a significant change to current organizational function, such as what would be expected by addition of an evidence-based PWMI within a new setting.

FE is an iterative process consisting of four stages at different time points.28 The first of these stages is developmental FE, the focus of this article. Developmental FE occurs before the initiation of an intervention. At this stage, the focus is on identifying current practices, contextual factors around current practices, and prospective barriers and facilitators to implementation. This stage guides the selection of specific implementation strategies19 that may be most appropriate to address the identified barriers to implementation. RI-CORD 3.0 employed a detailed developmental FE process before implementing the JOIN for ME program. The second stage is implementation-focused FE, which occurs throughout an implementation effort and is used to detect divergences from the implementation plan as it is being executed. Typically, implementation-focused FE identifies issues that were not captured with developmental FE and provides real-time documentation of barriers and facilitators as they arise. The third stage, progress-focused FE, is also an ongoing process during an implementation effort, although in contrast to implementation-focused FE, and is geared toward identifying progress toward implementation goals and initiating action to address issues as they arise, not documentation. Finally, interpretive FE is completed at the end of a project and is used to assess the outcome of an implementation project and collect opinions from stakeholder groups.

Implementation-focused FE will take place throughout the course of the project, involving meetings with key stakeholders, ongoing discussions with community health workers who will deliver the intervention, and engagement with community organization leaders/champions, to capture the barriers and facilitators of the implementation as it is occurring. Progress-focused FE will be used to document whether selected implementation strategies have addressed these barriers to implementation; implementation strategies will be adjusted as needed, based on these data, throughout the course of the project. Finally, interpretive FE will be conducted after the implementation of the JOIN for ME intervention. Mirroring the process for initial developmental FE, follow-up focus groups of individuals who participated in the intervention, as well as key stakeholder interviews, will provide feedback to assess the outcomes of the implementation project. This ongoing FE process will promote continued focus on health equity through consideration of social determinants of health as part of the ongoing collaborations with organizations and stakeholders to leverage and build upon community resources.

It is critical that FE be guided by a theoretical framework.28 Basing evaluation in theory allows for systematic assessment and monitoring of individual, organizational, and contextual factors and comparison with other similar projects. Utilization of frameworks can also guide the use and selection of implementation strategies to promote the uptake of evidence-based practices, leading to successful implementation. Within this study, we sought to incorporate both a broad framework for implementation research (Consolidated Framework for Implementation)29 and more focused attention on specific implementation outcomes (Proctor Implementation Outcomes Framework)30 to best drive the FE process and future intervention adaptation. These selected frameworks for FE will be utilized throughout all stages of FE in our project to consistently drive successful implementation.

Consolidated Framework for Implementation Research

The CFIR is a commonly used framework in implementation research that is readily able to guide FE.29 CFIR identifies the complex and interacting constructs impacting the implementation of evidence-based practices in real-world settings. It includes five major domains, and related subdomains, that provide guidance for the areas that should be assessed within any implementation project (Fig. 1). They are (1) the characteristics of the intervention, (2) the outer setting, which includes the cultural context in which an organization exists, (3) the inner setting, which references the contexts through which the implementation process will proceed, (4) characteristics of individuals involved in the intervention, and (5) the implementation process, which is the change process from all levels that contribute to the successful implementation of the intervention. To optimize success of an implementation project, these five domains (and their subdomains) provide a clear roadmap for the key constructs to consider in FE efforts.

Figure 1.

Figure 1.

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CFIR. The CFIR29 contains a number of constructs across five domains to consider when assessing the climate for implementation of an evidence-based intervention. CFIR, Consolidated Framework for Implementation Research.

Potential implementation issues identified through the use of CFIR in delivery of PWMIs will vary based on the unique setting. Damschroder and Lowery31 identified Veterans Affairs (VA) hospitals that had both high and low implementation success of the national roll-out of MOVE!, the VA's behavioral weight loss program. Using interpretive FE at the conclusion of the study, CFIR guided the team in identifying the supportive or prohibitive implementation processes of MOVE! at each site.31 For instance, within the inner setting domain (the hospital), the networks and communication subdomain strongly distinguished among sites that were successful or unsuccessful at implementing MOVE! Although the interpretive FE in the context of the CFIR was particularly useful for identifying differences between sites, use of developmental FE during early stages of the study may have allowed researchers to modify implementation strategies to address the communication concerns and promote and improve implementation. Following the previous example of networks and communications distinguishing sites, researchers uncovered that communication between MOVE! staff and other providers and patients was poorer at low implementation sites; they were either unaware of or misinformed about the program. With use of a developmental FE, the implementation team may have identified specific implementation strategies to address these concerns before large scale implementation, such as conducting educational meetings or outreach visits to inform patients and providers of the purpose and utility of the MOVE! program, which may have enhanced its success. RI-CORD 3.0 includes the use of CFIR throughout all stages of FE to facilitate timely identification and uptake of implementation strategies.

Proctor Implementation Outcomes

In addition to the use of the CFIR, FE can be used to promote more successful implementation outcomes. Proctor et al.30,32 have identified eight key implementation outcomes to measure the success of an implementation. These outcomes are acceptability, adoption, appropriateness, feasibility, fidelity, implementation costs, penetration (reach), and sustainability (Fig. 2). Depending on the construct, the outcome can be measured at the patient level (e.g., acceptability, appropriateness), provider level (e.g., feasibility, fidelity), or organizational level (e.g., costs, penetration, sustainability). Some implementation outcomes may be measured across all three levels (e.g., adoption, feasibility). Notably, implementation outcomes are distinct from individual health outcomes, which are generally the target of efficacy research (e.g., symptomatology, satisfaction, function).

Figure 2.

Figure 2.

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Proctor implementations outcomes framework. Proctor's30 implementation outcomes framework includes eight implementation outcomes that are conceptually different than previously identified service and patient outcomes.

In the context of JOIN for ME, individual health outcomes could include relative weight (e.g., percentage overweight) reduction and improvement in physiological and psychosocial indicators (e.g., blood pressure, quality of life). Service-level outcomes are distinct and refer to the quality of services given (e.g., safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity), which, in the JOIN for ME program, may include ensuring similar access for children of different socioeconomic status and ensuring weight losses are not extreme or unhealthy. Focus on these service-level outcomes also improves focus on health equity and focus on the context in which the intervention is being delivered. According to Proctor, implementation outcomes will affect the patient- and service-level outcomes, indicating that without successful implementation, the intervention delivery and outcomes will not function as originally intended. Thus, a PWMI may not produce expected relative weight reduction or have equitable distribution among a population if there is no plan to address implementation outcomes.

Developmental FE for Implementation of the JOIN for ME Program

The objective of the CORD 3.0 projects is to adapt, test, and package effective programs to reduce obesity among children from low-income backgrounds. To that end, the goal of the RI- CORD 3.0 project is to implement the evidence-based JOIN for ME program through housing authorities and a federally qualified health center across three communities, to reduce barriers to participation for children (ages 6–12 years) from low-income backgrounds with overweight and obesity.

Prior implementation research indicates that FE informed by the CFIR framework and Proctor implementation outcomes can greatly strengthen the success of implementing an evidence-based practice, especially in the context of a novel setting.28,30,31 As such, RI-CORD chose these frameworks to guide the FE process.28,30,31 Of primary importance in data collection for FE, which can be quantitative and/or qualitative in nature, is the involvement of key stakeholders to provide insight into complex issues surrounding implementation efforts.28 In this section, we describe how the CFIR and Proctor models can be applied to key stakeholder interviews during the developmental FE process to inform appropriate implementation strategies to support increasing the uptake of the intervention in community settings. We will use samples from the key stakeholder interviews to illustrate this process.

The developmental FE was conducted to understand the potential for dissemination and implementation of JOIN for ME in the targeted communities. In the context of this study, the first step of developmental FE was key stakeholder interviews conducted with members of the community organizations central to our implementation process (e.g., providers and staff from the federally qualified health center), community leaders in related organizations (e.g., wellness program coordinator of a local community center), and past JOIN for ME coaches with experience delivering the intervention. Interviews were designed to understand key stakeholders' perceptions of dissemination and implementation of the JOIN for ME program in their community. The semistructured interview script was developed to focus on the needs of the community, engagement and retention of families in the JOIN for ME program, and available community resources. Specifically, key stakeholders were asked to reflect upon perceptions of pediatric obesity within their community, the proposed implementation of the JOIN for ME program, as well as facilitators and barriers to engaging families and sustaining programs in their communities. Interviews were conducted by one team member, whereas another took extensive notes during the interview process, capturing as much information verbatim as possible. All procedures were approved by The Miriam Hospital Institutional Review Board.

A directed content analysis,33 guided by CFIR29 constructs and Proctor30 implementation outcomes, can be used to drive the translation of qualitative interviews into selection of implementation strategies. For example, key themes from stakeholders aligning with the CFIR could include perspectives on the planned intervention approach, the broader community context of stakeholders' local municipality, the potential functioning of JOIN for ME within their organization (i.e., low-income housing and federally qualified health centers), and the characteristics the stakeholders and their organizations may embody that could impact implementation success. Proctor implementation outcomes30,32 can identify areas that stakeholders would categorize as either strengths or weaknesses of the current intervention in terms of future implementation and dissemination. Once complete, theory-driven developmental FE based on data from the qualitative interviews can be used to support the selection of specific implementation strategies to support uptake of the JOIN for ME program in community-based settings. Although not within the scope of this article, a planned forthcoming article will include full qualitative analysis describing how key stakeholder interviews and focus groups result in adapting the JOIN for ME curriculum to match the needs of the population.

Sample Stakeholder Themes That Could Be Used to Shape Implementation Strategies

Key stakeholders were asked to reflect on areas to promote improved implementation effectiveness. Aligning with work focused on the importance of health equity in designing for implementation,22,23 conversations with key stakeholders included attention to the needs of the characteristics of individuals involved—families and children who would benefit from the intervention (e.g., transportation concerns for in-person meetings, ability to engage both caregivers and children simultaneously)—and the larger implementation climate of the setting in which JOIN for ME will be embedded (e.g., ability of the organization to prioritize childhood obesity in the context of other pressing needs including health care and housing). The CFIR and Proctor frameworks are used to help the team to identify these implementation determinants, which will guide the selection and use of evidence-based implementation strategies18,19 to address areas of potential concern after the completion of qualitative data collection. Identified implementation strategies will be used to promote uptake of the JOIN for ME program, with the goals of using specific strategies to address the barriers and facilitators to broader implementation of PWMIs.16

Key stakeholder interviews can be used to highlight the primary areas of concern in the community, as well as how these may impact the overall implementation of a PWMI, such as the JOIN for ME program. To exemplify the use of stakeholder feedback, Table 1 presents examples of key stakeholder feedback about barriers and facilitators to the implementation of the JOIN for ME program in the community, how this feedback aligns with constructs from the guiding frameworks, and the potential implementation strategies that could be employed to promote increased uptake of the JOIN for ME intervention.

Table 1.

Exemplar Key Stakeholder Concerns and Associated Potential Implementation Strategies from Developmental Formative Evaluation Process

Example key stakeholder concern Sourcea Associated construct Definition of construct Exemplar stakeholder perspective Potential implementation strategies
Cultural fit of the intervention for the large number of Spanish-speaking/Hispanic families within organization Proctor Appropriateness Perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation or evidence-based practice to address a particular issue or problem. It is important to talk about food and vegetables that families eat as part of their culture, talking about carrots is not effective, instead need to focus on food that families eat, such as plantains. Families need ways to not abandon food that is important for their culture, but find ways to cook that food in a healthy way. Promote adaptability, obtain and use patients/consumers and family feedback
Lack of transportation to intervention location Proctor Feasibility Extent to which a new innovation or practice can be successfully used or carried out within a given agency or setting. The 16 weeks do not worry me if we figure out ways to remove barriers, especially in winter and transportation becomes an issue. Having the program available in the community, whether community health center or community center, but in proximity will help families with many barriers, especially in families from low-income backgrounds. Change service sites, virtual delivery
Provider/organizational prioritization of primary responsibilities (e.g., housing, health care), despite belief in importance of addressing pediatric obesity CFIR Relative priority (subset of inner setting) Individuals' shared perceptions of the importance of the implementation of the organization. My job is to keep doors open financially, keeping doors open and keeping staff employed, then come other issues. Meeting the expectations of funders and the outcomes are a priority. Meetings like this (the current meeting) remind me of the bigger issues, but how can we sustain and retain it when there are other priorities. Conduct educational outreach visits; inform local opinion leaders; identify and prepare champions
Family poverty impacting ability to access low energy density foods (e.g., fruits and vegetables) CFIR Patient needs and resources (subset of outer setting) The extent to which patient needs, as well as barriers and facilitators to meet those needs, are accurately known and prioritized by the organization. Managing obesity is not a priority in our community given food scarcity. If families do not have enough money for food, they are not focused on calories and nutrition. There is a need especially in our Latino community to educate to about how to manage budget while eating healthy food and focusing on nutrition. Build a coalition, develop educational materials, intervene with patients/consumers to enhance uptake and adherence
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a

Potential sources are the CFIR and Proctor Implementation Frameworks.

CFIR, Consolidated Framework for Implementation Research.

To elaborate on one example from Table 1, derived from our theoretical frameworks, key stakeholders emphasized that it may be difficult to prioritize pediatric obesity treatment in the context of other community concerns (e.g., housing, health care, drug abuse). The relative priority of the current intervention, in the context of the CFIR inner setting, provides the research team with the necessary context to identify appropriate implementation strategies of educational outreach and working with opinion leaders to improve uptake of the intervention. The low relative priority of intervention also confirms the prospective decision of the research team to use the implementation strategy of identifying specific “champions” within each community setting, to promote increased uptake of the intervention. These potential implementation strategies underscore how theory-informed FE can be successful in enhancing the use of JOIN for ME program in community-based settings.

Conclusions

The use of FE, driven by evidence-based theory, can help provide a roadmap to successful implementation of the JOIN for ME program. This article highlights how key informant interviews from individuals in the community can facilitate the developmental FE process to implement an evidence-based intervention. During the first phase of the RI-CORD project, developmental FE is being used to guide selection of implementation strategies. Continual use of CFIR and the Proctor implementation outcomes throughout each FE phase will support ongoing uptake of the intervention and evaluation of the implementation project to best position the JOIN for ME program for enduring dissemination. Use of FE informed by CFIR and Proctor implementation outcomes will support the overarching goal of the project to deliver a disseminable PWMI that can be sustained over time.

Disclaimer

The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, CDC/HHS, AHRQ, NIH, or the US Government.

Funding Information

This study was supported by the CDC (Award No.: U18DP006429; Clinical trials number NCT04647760). K.E.D. was supported by an NRSA postdoctoral fellowship from the Agency for Healthcare Research and Quality (F32HS02707). J.F.H. was supported by an NRSA postdoctoral fellowship from the National Heart, Lung, and Blood Institute (T32HL076134).

Author Disclosure Statement

Dr. Jelalian is a consultant for Weight Watchers International. Weight Watchers has not provided financial support for this study, nor did it have any influence on the methods in this study. All other authors declared no conflicts of interest.

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