Protocol for the Rhode Island CORD 3.0 Study: Adapting,Testing,and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities

Abstract

Background:

Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects.

Methods:

The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI, JOIN for ME, for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination.

Conclusions:

If the adapted version of the JOIN for ME intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds.

ClinicalTrials.gov no. NCT04647760.

Introduction

Overweight and obesity in youth is a public health crisis in the United States.¹ Obesity and its associated comorbidities are more common, diagnosed later, and result in worse health outcomes among youth who live in communities with a high prevalence of low income.^2–5 Longitudinal nationally representative data suggest that children from the lowest income families are twice as likely to have obesity during childhood as compared with those from wealthier families.⁶ This increased risk is compounded by the fact that children from low-income communities are less likely to have access to or benefit from available weight control programs.^7–9

In 2017, the U.S. Preventive Services Task Force (USPSTF) reissued a Grade B recommendation, initially made in 2010,¹⁰ for clinicians to screen children ages 6–18 years for obesity and refer identified youth to comprehensive multicomponent treatment programs with >26 contact hours that include nutrition and physical activity targets and are supported by behavioral strategies.¹⁰ Reissue of this recommendation highlights the continued importance of comprehensive family-based programs with broad accessibility. Although such programs are recommended, they are not widely available, with only 52% of children's hospitals surveyed in 2013 offering comprehensive multidisciplinary pediatric weight management programs consistent with USPSTF guidelines.¹¹ Access is further impeded by lack of payment for available services,¹² as a result of which the majority of children in the United States do not receive evidence-based treatment of obesity, with few such programs available to youth from low-income backgrounds.¹³

Dissemination of evidence-based pediatric weight management interventions (PWMIs) to diverse communities with a high prevalence of low income is a key objective of the CDC Childhood Obesity Research Demonstration (CORD) projects.¹⁴ The goal of this article is to describe the approach taken by the Rhode Island (RI) CORD 3.0 project in adapting and testing an evidence-based PWMI, JOIN for ME, in communities with a high prevalence of low income, with specific attention to the study rationale, process for curriculum adaptation, and plan for testing the adapted intervention.

Rationale for Testing the JOIN for ME Program

JOIN for ME is an evidence-based PWMI that meets the USPSTF recommendations.^15–17 JOIN for ME (v.1.) was developed as a collaboration between UnitedHealth Group (UHG) and Y-USA, and is now managed by a UHG subsidiary, Rally Health. The curriculum was informed by principles from empirically supported family-based behavioral weight control interventions. Drawing on dissemination and implementation science frameworks, JOIN for ME was originally designed to be a group-based intervention delivered in community settings (e.g., YMCA) and to include treatment materials in English and Spanish, as well as facilitator training materials. The intervention was intended to be delivered by nonhealth care professionals with a combined group of caregivers and children to reduce implementation costs and increase scalability, enhancing ability to reach its intended target population and the likelihood of adoption across a range of delivery organizations and communities.¹⁸

Evidence supporting the effectiveness of the JOIN for ME (v.1.) program comes from an open trial¹⁵ and randomized controlled trials with children and adolescents.^16,17 In the former, children between the ages of 6–12 years demonstrated a 4.3% reduction in percent overweight, in an intervention delivered at area YMCAs by YMCA facilitators.¹⁵ These changes, observed at 6 months, persisted at 18-months follow-up.¹⁹ After the testing phase, several modifications were made to the program, including addition of eight monthly booster sessions and inclusion of an initial caregiver orientation session with accompanying caregiver handbook describing program rationale and philosophy. These changes resulted in a final “JOIN for ME” (v.2.) program that includes (1) 16 weekly group-based in-person sessions followed by 8 monthly sessions (24 sessions of 75 minutes each for 30 hours of curriculum), which caregivers and school-age children attend together; (2) calorie guidelines that are actualized by setting targets for “YES” and “LESS” foods, a simplified nutrition message that was selected to increase adherence; (3) prescriptions for increasing physical activity and decreasing sedentary behavior to align with the national physical activity guidelines; and (4) focus on key behavioral topics included in evidence-based PWMIs, such as self-monitoring, goal setting, and reinforcement.

Introduction to RI CORD 3.0

The RI CORD 3.0 project involves a partnership with Rally Health to examine the JOIN for ME program in a hybrid effectiveness-implementation trial in which the aims are to understand the context for intervention implementation as well as to examine patient-centered outcomes.²⁰ Rally Health retains ownership of the curriculum. They will provide the research team with access to all aspects of the program, engage in ongoing collaboration regarding intervention adaptation and delivery, as well as on plans for subsequent dissemination of the program. Context for intervention implementation refers to the multiple contextual variables that impact intervention delivery, including setting, mode of delivery, credentials of the facilitators, and engagement of partner organizations. Informed by Proctor's Implementation Outcomes Framework,^21,22 we will examine the key implementation constructs of (1) acceptability, (2) adoption, (3) feasibility, (4) fidelity, (5) penetration²³ (i.e., reach), and (6) cost.^21,22 Comprehensive assessment of implementation, across multiple levels, combined with examination of effectiveness is critical for establishing dissemination potential, yet infrequent in pediatric obesity interventions.²⁴

In the open JOIN for ME trial, 31% of participants were insured by state insurance, but the curriculum was not designed specifically for this demographic. To optimize implementation metrics and to adapt program delivery to increase engagement of families from low-income backgrounds,^25–29 several steps will be taken. (1) To increase penetration, JOIN for ME will be offered in settings that serve children and families from communities with high rates of low income and overweight/obesity (South Providence, Central Falls, and Woonsocket). (2) To increase program acceptability, JOIN for ME will be delivered remotely. Although this adaptation was not part of the original research plan, a decision was made to deliver the intervention remotely in light of restrictions to in-person group meetings stemming from the coronavirus disease 2019 (COVID-19) pandemic and simultaneously addressing the frequently cited barrier of transportation.²⁶ To facilitate virtual participation, families will be provided with a scale for weekly weigh-ins, a Wi-Fi hotspot, and a tablet loaded with intervention materials, a web resource tool and diet tracking apps. (3) To support both penetration and acceptability all program materials will be made available in Spanish as done by UHG in v.1. In addition, curriculum images, diet and physical activity examples, and literacy level will be adapted after a formative evaluation phase with the target population. (4) To increase acceptability and adoption, families will be provided access to a web resource developed by the Hassenfeld Child Health Innovation Institute, which maps food stores and physical activity opportunities for children in each community, as well as access to the Healthy Habits program offered by the RI Community Food Bank.

Selection of Settings and Facilitators for Intervention Delivery

The selection of intervention settings and facilitators in RI CORD 3.0 was designed to increase family engagement with the JOIN for ME program based on commonly cited barriers to PWMI participation.³⁰ The original intent was for intervention settings to serve as sources of recruitment as well as physical locations for the delivery of JOIN for ME. However, with the transition to virtual intervention delivery, settings serve as organizations from which participants are recruited. The intervention is being delivered in collaboration with the two easily accessed familiar settings of low-income housing and a patient-centered medical home (PCMH)/federally qualified health center (FQHC). Health-focused interventions have been successfully delivered in subsidized housing to address smoking cessation,³¹ increase fruit and vegetable consumption,³⁰ increase physical activity, and improve eating and activity environment in adults,^32,33 and improve health behaviors in adolescents with obesity.^34,35 The precedent for delivering health behavior interventions within low-income housing and the fact that housing authorities offer supportive health-related programming to its residents³⁶ makes this an opportune setting for testing a PWMI.

Another commonly cited barrier to participation in programs is trust.³⁰ Offering JOIN for ME in collaboration with a PCMH, described as a model of care, that is, comprehensive, patient-centered, coordinated and team-based, accessible, and focused on quality and safety,^37,38 helps to alleviate some concerns related to trust, as families are already familiar with the organization and its employees. The goals of the PCMH align well with the mission of treating families from underserved communities where they live, improving access to a wide range of family-centered health services, and ensuring continuity of care. Offering the JOIN for ME program in collaboration with a PCMH/FQHC serving children and families from communities with a high prevalence of low-income and focusing on holistic comprehensive care is a natural fit and will allow testing of a sustainable model.

Community health workers (CHWs) were selected to deliver the JOIN for ME intervention given the central role they play as intermediaries between health care systems and the community to increase access to care. CHWs are frontline public health workers and trusted members of the community of interest, giving them the potential to improve the quality and cultural competency of service delivery.³⁹ The Affordable Care Act called for the inclusion of CHWs in preventive health services to improve the efficiency and cost of health care and included regulations that allow state Medicaid programs the opportunity to use nonlicensed providers (e.g., CHWs) to provide preventive service.⁴⁰ Since then, several programs have demonstrated the effectiveness of CHWs in pediatric health interventions. A recent meta-analysis examining the effectiveness of using CHWs to deliver PWMI in underserved communities showed that interventions led to small but statistically significant decrease in adiposity.⁴¹ Similarly, in a study of Latino children with asthma, integrating CHWs into PCMH led to a significant increase in the number of referrals to a care coordination program (67–79%).⁴² In this capacity, CHWs have significant potential to reduce health disparities as they expand upon traditional care by providing social support and connecting families with local resources. Furthermore, they provide a model for intervention delivery that may be disseminated across intervention settings.

Community Resources Supporting Engagement with Intervention Components

Families are provided with two adjunctive resources to support their engagement with the JOIN for ME program in RI CORD 3.0. We have partnered with the Rhode Island Community Food Bank to provide access to the Healthy Habits curriculum, a six-session program for caregivers of school-age children that includes cooking demonstrations, information on eating healthy on a limited budget (stretch dollars and use of Supplemental Nutrition Assistance Program [SNAP] benefits), recipe review and tasting, and opportunity to practice food preparation at home through provision of food items with recipes. A program similar to Healthy Habits delivered through the RI Community Food Bank was effective in decreasing food insecurity and reducing BMI in adult participants.⁴³ Owing to restrictions resulting from COVID-19, the intended in-person programming is not available. Instead, the Food Bank has developed a collection of cooking demonstration videos and related materials that is shared with enrolled families. By offering the materials in tandem with implementation of the JOIN for ME program, families will be supported in learning the requisite skills and provided with resources to successfully enact program goals.

A second adjunctive support provides families with an easily accessed website that locates neighborhood resources consistent with program goals, which includes identifying locations for purchasing healthy foods at low cost and safe recreational facilities. Increasing awareness of available resources has been positively related to changes in physical activity and diet.^44–47 The website was developed through the Data Core of the Hassenfeld Child Health Innovation Institute, an organization that brings together key community partners in RI, including researchers, state and municipal governments, nonprofit organizations, the business community, and families, in a collaborative effort to address the health needs of children.

Formative Evaluation and Preparation to Inform Intervention Adaptation and Delivery

RI CORD 3.0 includes a formative evaluation and planning phase, which serves to identify influences on the implementation efforts to adapt intervention materials and enhance community collaborations to support program delivery. The goal of adapting the JOIN for ME program is to increase acceptability and increase usability for families from low-income backgrounds. Key activities of this phase of work include establishing a community advisory board (CAB) and engaging with community coalition partners, obtaining critical stakeholder feedback to inform adaptation of intervention components for families from low-income backgrounds, and refining training materials. The initial formative evaluation phase has been completed. Hereunder we describe the primary activities undertaken.

A CAB⁴⁸ was convened at the start of the project to ensure broad representation of the community and our study population,⁴⁹ including stakeholders from the three recruitment/implementation sites as well as representatives from key organizations such as the RI Healthy Schools Coalition, the RI Department of Health, the RI Community Food Bank, and PCMH-Kids in RI. This high-level CAB provides input regarding strategies for reaching prospective families and effectively promoting the intervention in the target communities as well as understanding complexities related to implementation challenges within each setting. This group was convened multiple times during the first 12 months of the project and will continue to meet throughout intervention implementation. We also identified intervention “champions,” or internal facilitators, within each setting to collaborate with the research team on intervention recruitment and delivery,⁵⁰ a strategy that has been associated with successful implementation of community-based PWMIs.⁵¹ On a community-specific basis, each internal facilitator is paired with a CHW and members of the research team (i.e., external facilitators), which is the basis for a highly effective implementation strategy known as blended facilitation.⁵² Specifically, champions help to increase program awareness within their organizations, promote the program within their communities, and share program information with interested families.

The formative evaluation work (key-informant interviews and focus groups) was undertaken with specific attention to delivering the JOIN for ME intervention to the target audience (i.e., families from low-income backgrounds), and a focus on cultural adaptation (i.e., making the curriculum relevant to Latino families). The approach to intervention adaptation was informed by several frameworks from implementation science, a summary of which is provided in Table 1. At a high level, our strategy was guided by the Framework for Reporting Adaptations and Modifications—Expanded (FRAME) to make decisions and report the need for modifications to evidence-based interventions.⁵³ Specific adaptations to the JOIN for ME curriculum were informed by the Adaptome, which provides guidance regarding sources of intervention adaptation, with attention to five key domains, including the service setting, target audience, mode of delivery, cultural context, and core components of the intervention.⁵⁴

Table 1.

Implementation Science Frameworks Used to Inform Adaptation of the JOIN for ME Program

Framework	Overview	Timeline in implementation	Use of implementation frameworks in JOIN for ME
Adaptome	Guides fidelity-consistent adaptations to increase the fit between interventions and the populations and contexts to improve implementation.	Formative evaluation (preimplementation)	Adaptome will be used to guide analysis of focus group data to develop specific adaptations, especially in the areas of target audience, mode of delivery, and cultural context adaptation.⁵⁴
FRAME	Framework developed to organize and report specific adaptations made for an implementation, including organization of who is involved in modification, what is modified and at what level, the nature and intent of modifications, as well as multiple other aspects of categorizing modifications made.⁵³	Formative evaluation (preimplementation)	The FRAME will be used to organize the adaptations made in this study to improve the implementation of JOIN for ME, with input from key stakeholders, focus groups, the research team, community organizations, and CHWs delivering the intervention.
Proctor Implementation Outcomes	A taxonomy of outcomes specific to implementation to distinguish from service and client outcomes, which includes information on level of analysis, implementation stage, and available measurement of outcomes.²¹	Formative evaluation (preimplementation); implementation	Proctor's implementation outcomes framework will be used to guide use of implementation strategies, adaptations made, and key outcomes (including service and implementation-level outcomes).
CFIR	This framework consolidates and unifies prior implementation theory to provide structure to the multiple interacting levels of implementation to guide formative evaluation and implementation of an evidence-based intervention.⁷²	Formative evaluation (preimplementation)	The CFIR will be used to identify specific barriers and facilitators of the JOIN for ME implementation across different domains, which in turn allows for the identification of specific implementation strategies to overcome identified barriers.
SIC	This observation-based measure tracks the achievement of implementation milestones across preimplementation, implementation, and sustainment phases to monitor implementation of an evidence-based intervention. Results can be used to highlight potential areas to strengthen ongoing implementation.⁷⁰	Throughout	We adapted the SIC to capture the ongoing components of implementation of JOIN for ME. Through tracking the date of each aspect of implementation, stage duration, and proportion of activities in each stage, the SIC will be used to inform future implementation efforts of JOIN for ME to improve likelihood of sustainability.
COINS	Paralleling the SIC, this measure is used to track costs at each stage of implementation to generate total cost of the implementation, with ability to strategy by stage of implementation.⁷⁴	Throughout	The COINS will be used to track direct and indirect costs associated with implementing JOIN for ME to provide approximate cost of future implementation in community-based settings.

CFIR, Consolidated Framework for Implementation Research; CHWs, Community Health Workers; COINS, Cost of Implementing New Strategies; FRAME, Framework for Reporting Adaptations and Modifications—Expanded; SIC, Stages of Implementation Completion.

Curriculum adaptations were informed by two sources: (1) key stakeholder interviews with local leaders of community organizations and facilitators who have delivered the JOIN for ME intervention and (2) focus groups with children and caregivers drawn from the target population in each of the three communities from which participants are recruited. Key stakeholder interviews focused on implementation and sustainability of the JOIN for ME program in the three communities identified. In brief, these interviews were coded to shape implementation strategies used to increase implementation effectiveness. A description of the procedures and utilization of information from key informant interviews is presented in a companion publication.

Focus groups were conducted with caregivers and children to elicit feedback on the accessibility, language, images, and activities in the JOIN for ME curriculum. Information was also sought regarding approaches for self-monitoring, incentive structure to support family engagement, resources featured on the website, cultural appropriateness and literacy level of the curriculum, and plans to deliver the intervention through a remote platform. Consistent with the Adaptome, focus group transcripts were coded to identify adaptations to planned intervention content and delivery. This coding drove fidelity consistent adaptations in the areas of target audience, cultural context, and mode of delivery as outlined by the Adaptome.⁵⁴ The FRAME guides the categorization of the nature of adaptations made at each level of delivery, after focus group and key stakeholder findings.⁵³

A final activity undertaken before intervention implementation was adaptation of facilitator training materials. Historically, facilitator training has been conducted through in-person sessions. Consistent with plans for remote intervention delivery and to increase dissemination potential, training materials, including a series of power point presentations combined with interactive activities and embedded content quizzes, were migrated to a web-based platform. These materials served as the launch point for a series of 1-hour remotely delivered training sessions. Specifically, the CHWs participated in Zoom-based training sessions led by our research team, which included both self-directed assessments and session role-plays with real-time feedback. Once the intervention has been delivered, we will conduct key-informant interviews with the CHWs to inquire about potential improvements to the training program, and make modifications as indicated.

Test of the Adapted Intervention and Second-Stage Adaptation

Study Design

Formative evaluation led to a revised version of the JOIN for ME curriculum, which will be tested in three different low-income settings in RI: an FQHC in Providence, which serves as a PCMH, and low-income housing in Central Falls and Woonsocket. This study employs a delayed treatment design, wherein a series of active/delayed treatment groups are conducted within each of the three settings. A cohort of 12–16 families will be enrolled in each community and assigned to participate in either the active or delayed treatment condition. Families will be assigned to a group based on their child's birth month, and then treatment (active vs. delayed) will be assigned at random. The delayed treatment paradigm is such that one group begins treatment immediately after baseline assessment, whereas the second group waits 4 months (i.e., length of time of the intensive intervention phase), at which time they complete a second baseline assessment and begin treatment. This design allows all participants to receive the intervention, while providing a comparison of active and delayed treatment conditions at 4 months.

A total of 128 participants will be recruited and enrolled into the JOIN for ME program (64 parent/child dyads in the immediate-treatment groups and 64 dyads in the delayed-treatment groups). Families will be recruited in partnership with our community partners. Specifically, the FQHC will use directed mailings and physician referrals to promote the program, whereas the housing authorities will rely on mailings, social media, and community events. Consistent with the CORD 3.0 focus on elementary school-age children from communities with a high prevalence of low income, to be eligible, children must (1) be 6–12 years old, (2) have a BMI ≥85th percentile for their age and gender, (3) have at least one caregiver available to provide consent and participate in sessions, (4) speak English or Spanish, and (5) agree to study participation and delayed treatment onset. Children will be excluded if (1) either the child or the caregiver is currently involved in another weight-loss program, (2) have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity, (3) are developmentally delayed such that the intervention materials will not be appropriate, or (4) are in treatment for or diagnosed with a major psychiatric disorder, including an eating disorder. Primary care providers will be notified of their patient's enrollment in the JOIN for ME program.

Consistent with the model for in-person delivery, the JOIN for ME program will be delivered to families over 10 months. In groups of six to eight dyads, parents and children will complete 16 weekly 1-hour remote sessions, followed by 6 months of mastery sessions (four biweekly sessions and four monthly sessions). The groups will be delivered through the Health Insurance Portability and Accountability Act (HIPAA)-compliant Zoom platform. To facilitate remote delivery, the intervention has been adapted to include a brief (10–15 minutes) individual weekly Zoom meeting with each dyad in advance of the group session to collect weekly weights and check-in on goal achievement. Fidelity-consistent interactive activities are also embedded within sessions to enhance participant engagement.

Consistent with a hybrid effectiveness-implementation trial design, we are examining patient-centered outcomes related to treatment effectiveness, while also conducting in-depth assessment of the context for intervention implementation.²⁰ Robust assessment of implementation metrics provides critical data for subsequent adaptation, delivery, and potential dissemination of the JOIN for ME program.

Effectiveness Outcomes

To test the effectiveness of the adapted JOIN for ME curriculum, dyads will complete study assessment visits at baseline, and at 4 and 10 months. Those assigned to the delayed treatment group will complete a second baseline assessment, before starting the intervention. This will allow us to examine both between-subject and within-subject effects. The between-subject effects will compare change from baseline to post-treatment in the immediate-treatment groups with change from the first to second baseline in the delayed-treatment groups. Primary measures of effectiveness include changes in child weight status, as measured by percent overweight, and caregiver weight status, as measured by absolute BMI. Caregivers will also complete the Family Nutrition and Physical Activity Screening Tool,¹³¹ a measure of environments and practices thought to influence children's risk for overweight/obesity. Additional outcomes include child health-related quality of life, as measured by the Sizing Me Up questionnaire,⁵⁵ which will be used in the cost-effectiveness analysis, as participant satisfaction and use of the web resources tool. The extent to which the intervention is successful in connecting families to available resources will be assessed through monthly surveys delivered through text throughout the intervention. Patient satisfaction will be assessed at 4- and 10-month assessment visits using a treatment satisfaction measure developed to evaluate response to the intervention, facilitators, and barriers to program engagement.⁵⁶ We also assess social determinants of health, including food and housing insecurity, as well as neighborhood safety to assess potential associations with participant outcomes. Specifically, caregivers will complete the 18-item USDA Household Food Insecurity Survey,⁵⁷ the Use of USDA Food Programs survey,¹³⁰ questions on housing insecurity through the Items from the CDC Common Measures—Housing form, and the NEWS-Y to assess neighborhood safety.⁵⁸

Service Outcomes

To align with Proctor's Implementation Outcomes Framework, several service outcomes are assessed, which are derived from the National Academy of Medicine's framework for quality care.^21,59 Timeliness: We will track the latency from the time when a family contacts our recruitment line, is scheduled for evaluation, and begins the JOIN for ME program. Families in the delayed treatment onset condition will provide valuable information regarding the extent to which latency in treatment onset contributes to program enrollment and engagement. Safety: A reporting system allows sites and intervention facilitators to monitor any negative outcomes associated with intervention delivery. Any such events are tracked in real time by encouraging families to report any injuries related to participation in physical activity, and so on, at the next contact with the CHWs. Participants are formally asked about any adverse events during each of the formal evaluation periods, which are reviewed with the Data Safety and Monitoring Board. Effective: Examining participant inclusion and exclusion criteria compared with metrics of participants enrolled in the study ensures that only participants who met criteria and to whom we intended to offer the intervention were recruited. Equitable: Characteristics such as gender, ethnicity, and geographic location are examined to assure that there are no differences in intervention delivery based on these domains.⁵⁹

Implementation Outcomes

Examining implementation outcomes, described as “the effects of deliberate and purposive actions to implement new treatments, practices and services,” in addition to the service and effectiveness outcomes provides information on the extent to which the program is successful as well as potential barriers and facilitators of real-world delivery.⁶⁰ Implementation outcomes derived from Proctor's Implementation Outcomes Framework⁶¹ include acceptability, adoption, feasibility, and fidelity, and penetration/reach. Questionnaires and interviews will be used to obtain information from relevant stakeholders, including referral sources, participants, group facilitators (CHWs), and community partners, as well as administrators from housing and the FQHC. The assessment of each domain is briefly described as follows.

Acceptability

Acceptability refers to the extent to which adoption of JOIN for ME is agreeable, palatable, or satisfactory among key stakeholders. We are using multiple strategies to determine the extent to which the intervention fills an important need and is expected to produce positive outcomes. (1) Referral sources: At the end of the study recruitment process, referral sources (e.g., providers and community organizations) will be asked to provide a narrative account to obtain their perspectives on the barriers and facilitators of the referral process. (2) Participants: We will conduct key informant interviews with three unique sources, including (i) caregivers who inquire about the study but do not complete the intake process to learn their reasons for declining; (ii) caregivers who are enrolled, but stop attending group sessions to understand barriers to engagement; and (iii) caregivers who complete the 10-month intervention to examine perspectives regarding the extent to which the skills taught were effective in supporting weight-loss efforts. These interviews will be semistructured, with open-ended questions to elicit (1) beliefs about the relevance and benefits of services offered, (2) expectations for services offered, (3) attitudes about help seeking more broadly, (4) situational, personal, and pragmatic challenges that hindered participation, and (5) ways they found to overcome barriers. Detailed information on acceptability of specific intervention content is also collected by asking caregivers to complete a two-item measure of treatment satisfaction at the end of each group session. Finally, CHWs will provide a rating of engagement for each dyad at the end of each session⁶² using a system adapted from Webster-Stratton and colleagues,^63,64 which captures differences in levels of engagement by session.⁶⁵

Feasibility

Feasibility is the extent to which JOIN for ME can be successfully carried out in connection with low-income housing or an FQHC. Specific components of feasibility include the extent to which caregivers are able to utilize the intervention components offered and the degree to which facilitators and administrators believe the intervention can be delivered as intended.

(1) Participants. A series of process measures will be collected during administration of the intervention to provide information regarding feasibility. These include attendance at group sessions of the JOIN for ME program, number of times that families access a program at the RI Community Food Bank, and the frequency with which our resource website is accessed. Families are asked about utilization of the Food Bank by group facilitators at monthly intervals. Metrics related to accessing RI Community Food Bank activities and the website will provide critical data regarding the relative utility of these adjunctive resources. (2) Each CHW will be interviewed at the end of the intervention phase of the study to provide information regarding feasibility of program implementation. Questions will focus on challenges with technology, difficulty contacting and engaging participants, and perceptions of organizational receptiveness to the JOIN for ME program. With the leaders of each community-based organization (housing authority and FQHC), we will monitor staffing patterns, including the number of potential applicants who express interest in positions and number of applicants screened to result in the necessary hires. This will inform the sustainability of the intervention as delivered by CHW. (3) Administrators at the FQHC and housing authorities will be asked about the feasibility of program implementation within the scope of ongoing programming. The 12-item Organizational Readiness for Implementing Change will assess the extent to which organizational members are prepared to implement JOIN for ME by measuring change commitment and change efficacy as two facets of organizational readiness.⁶⁶

Fidelity

Fidelity refers to the extent to which settings are implementing JOIN for ME as intended, according to the program developers. Key domains of interest include length of sessions, adherence to session content, and skill in intervention delivery. The transition to remote intervention delivery offers an advantage in allowing us to use a developed measure of fidelity to the JOIN for ME intervention⁶⁷ applied to a random sample of audio files recorded through Zoom. In addition, at the completion of each group session, CHWs record the extent to which the intended session content was delivered (yes/partial/no). Fidelity checklists have been used effectively as a less resource intensive assessment of fidelity in a number of previous implementation studies, with reasonable agreement between independent facilitator and observer ratings.^68,69 As part of the process of finalizing the dissemination plan, we will work with collaborators at Rally Health to determine how these metrics could be embedded within the final JOIN for ME package.

Penetration/reach

Penetration/reach is the extent to which the program is reaching the intended target population. Standard demographic variables such as age, gender, race, ethnicity, and education are recorded, as are family income, number of people living in the household, and languages spoken. Measuring these variables allows us to examine whether Penetration varies as a function of these individual-level factors. We will examine the demographics of recruited families and compare this with (1) the demographics of the community served by the specific setting as well as the broader community from which the participant is enrolled and (2) the demographics of children enrolled in other health-related programs that are located in proximity of low-income housing or the FQHC. This will provide us with an assessment of the extent to which we were able to recruit a representative sample from the community.

Additional Implementation Frameworks

Assessment of these key domains is accompanied by several other strategies to assess the implementation process. We have adapted the Stages of Implementation Completion (SIC) checklist⁷⁰ to focus on the eight stages of implementation of JOIN for ME within each setting, corresponding to the preimplementation (engagement, consideration of feasibility, and readiness planning), implementation (staff hired and trained, fidelity monitoring processes in place, services and consultation begin, ongoing services, and fidelity monitoring), and sustainment (achieving competency) aspects of the program. Prospectively documenting the date of achievement for each project activity undertaken within the SIC will provide critical information related to subsequent dissemination of the JOIN for ME program.

To “design for dissemination” from the beginning, the project is also informed by the Consolidated Framework for Implementation Research (CFIR), a widely used approach in policy and program implementation.^71–73 The five major domains in CFIR, including 39 subconstructs can identify both barriers and facilitators at multiple levels of implementation: (1) characteristics of the intervention, (2) the inner setting of an organization, (3) the outer setting, (4) characteristics of individuals involved, and (5) the process of implementation. For example, one subconstruct, “design and quality of packaging” of all intervention materials (e.g., curriculum and training materials), part of the characteristics of the intervention or innovation, is often critical for future dissemination and implementation of an intervention.⁷³ Another example is that JOIN for ME implementation with participants from one housing setting or FQHC may depend on the inner setting of the organization, including leadership views of the relative priority of JOIN for ME.

Program Costs and Cost-Effectiveness

Assessment of cost and cost-effectiveness analysis are designed to measure or quantify the cost to stakeholders of the application of the JOIN for ME intervention in housing and clinical settings, and to inform costs of possible future implementations. Documenting implementation activities according to the SIC (described earlier) also allows for an assessment of the cost of implementing new strategies (COINS) in the JOIN for ME in community-based settings.⁷⁴ Similar to a recent modeling study of a PWMI,³³ we are adopting a modified health system perspective, which includes direct medical costs and nonmedical costs (such as postage for mailings and community events) but excludes the opportunity cost of time spent by families making lifestyle changes. This means that we will calculate costs within the health system, broadly defined, but not count costs that fall outside, such as families' travel expenses and the value of their time. This approach allows us to determine costs that might potentially be paid by governments or insurers in the future, or by patients as co-payments for clinical services.

Our conceptual framework is time-based activity based costing (ABC), a tool used in developing normative bases for payment.⁷⁵ The needed time and economic data required to implement ABC will be collected using the validated Treatment Cost Assessment Tool.^76,77 We will identify each of the activities needed over the course of the JOIN for ME program, compute their costs, and use those results to obtain the cost per participant. For activities that plan to serve multiple families at once, we divide by the number of families to derive cost per client. In addition to identifying the program cost as it is administered in each setting, we will use the data to answer “what if” questions relevant for future policy, such as projecting how unit costs might fall if the program were scaled to a larger number of participants. Activity costs are broadly captured in the following six categories: on-site setup, software setup, training, recruitment, intensive implementation, and maintenance.

Finalizing the JOIN for ME Materials

Final packaging of the JOIN for ME program will proceed based on examination of findings from the implementation trial, including participant and implementation outcomes. More specifically, intervention materials will be revised and finalized based on acceptability and feasibility data obtained from families who enroll in the program (through process measures such as weekly attendance, real-time assessments of the utility of content covered in each session, and participant satisfaction), data from CHWs who deliver the intervention, as well as findings from the pilot implementation study. Moreover, using the Proctor and CFIR frameworks, qualitative analysis of key informant interviews from families who do and do not complete JOIN for ME will inform which aspects of program delivery require modification. Modified training materials will be converted to interactive formats and built into an internet-based platform that could be accessible to interested community organizations. Finally, using outcomes from the cost-effectiveness analysis, a per-family or site cost of delivering the JOIN for ME curriculum remotely will be determined to inform how to minimize financial barriers to the program while making it sustainable. These revised materials and an implementation blueprint will be placed on a web-based dashboard, which will serve as a dissemination tool for how best to implement the JOIN for ME program remotely. Thus, the program will be well positioned for scaling in other communities with a high prevalence of low income in RI and beyond.

Conclusions

The primary goal of the CORD 3.0 funding is to increase the availability of effective PWMIs for children from lower-income households. If the adapted version of the JOIN for ME program is shown to be effective, can be implemented with fidelity, and is acceptable and favorably viewed by participants and key stakeholders, this project will help to achieve this objective. Dissemination to other settings will be facilitated by access to an intervention package that includes an adapted curriculum, as well as materials for coach training, family recruitment and enrollment, cost estimates, and evaluation tools. Furthermore, our collaboration with Rally Health provides unique opportunity for sustainability planning, to ensure that the JOIN for ME program can be scaled up and spread to other settings.

Footnotes

Disclaimer

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

Funding Information

This project was supported by the Centers for Disease Control and Prevention of the US Department of Health and Human Services (HHS) with 100% of the research project funded by CDC/HHS (Award No.: U18DP006429). KED was supported by an NRSA postdoctoral fellowship from the Agency for Healthcare Research and Quality (F32HS02707). JFH was supported by an NRSA postdoctoral fellowship from the National Heart, Lung, and Blood Institute (T32HL076134).

Author Disclosure Statement

No competing financial interests exist.

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