Applying Navigation and Care to Help Ongoing Retention

Background: Pediatric obesity is common and complex. Pediatric obesity management (POM) can be successful, but most children need to receive a moderate to high intervention dose to improve obesity and health outcomes. Up to 80% of children in POM experience attrition (permanently), reducing treatment impact. Barriers are the most common reason for attrition, limiting family access to POM. Family Navigation (FN) is a strategy that supports families and improves health care access, satisfaction, and outcomes in other areas but is untested in POM.

Objectives: The primary objective is to examine the effectiveness of FN to reduce attrition in POM. The secondary objectives are to determine intervention effects on clinical and health services outcomes, compare the cost-effectiveness of experimental vs control groups, and complete a process evaluation to explore factors that impact FN implementation.

Trial Design: This trial is a multicenter, multimethod, hybrid type 1 effectiveness-implementation RCT, to concurrently test the effectiveness of a clinical intervention and identify enablers and barriers in real-world use. This 5-year trial has 2 arms - experimental (FN + Usual Care) and control (Usual Care only) with parallel assignment (1:1). Data analysts and POM clinicians will be blinded to group assignment. Children will be assigned to the experimental or control group after enrolling in multidisciplinary POM clinics in Calgary, Mississauga, or Ottawa.

Trial Interventions. The experimental group will receive FN + Usual Care. The control group will receive Usual Care only.

Developing FN: The FN intervention was co-designed as part of the investigators' feasibility RCT drawing on Experience-Based Co-Design to understand health service experiences, identify potential improvements, and make changes collaboratively.

Delivering FN: Each site will have a navigator to deliver FN to families in POM. Navigators will be trained and equipped with piloted resources to offer individualized support. They will orient families to the intervention, which includes completing a needs assessment to identify family strengths, challenges, and priority issues for accessing POM. Navigators will access diverse strategies (logistical and relational) to support families' unique needs and preferences.

Logistical strategies in FN: 1) Communication via text message. Navigators will use study-dedicated smartphones to connect with families to schedule and manage appointments, celebrate successes, troubleshoot barriers and constraints to care, and share educational resources. 2) Flexible navigator appointments. Aside from POM appointments, families and navigators will meet at convenient times, including evenings and weekends. Most appointments will be virtual, with opportunities available for in-person visits. 3) Parking/Transit passes (up to 15). Passes will be used for any in-person family visits with navigators, POM clinicians, or researchers. This access helps to provide children a moderate to high intervention dose, increasing likelihood of POM success. 4) Community-based resources. Navigators will compile resources and services (e.g., mental health support, physical/social activity programs) for families at each site. This strategy recognizes the many systems supporting child and family health.

Relational strategies in FN: Navigators will use principles of motivational interviewing (MI), a client-centered counselling approach used in most navigation interventions. MI encourages clients to actively engage in their care and resolve ambivalence about change, using purposeful communication strategies (e.g., expressing empathy, supporting self-efficacy), and improves treatment adherence. Navigators focus on listening to and validating family challenges, exploring desire to continue POM. They foster a safe, non-judgmental space for families to discuss expectations and experiences as well as empower families to access local resources and services that optimize care.

Navigators will be flexible and responsive. In some cases, they will work intensively with families through regular, frequent interactions; in other cases, they will offer more limited support and encouragement. Family needs drive appointment frequency with navigators, tailored to children's age and stage. FN acknowledges that readiness, willingness, and ability to make behavioral changes varies by family; ambivalence is common in obesity management. Navigator-family discussions will include children and caregivers together and/or separately, based on preferences and needs. Navigators will adhere to protocol if families disclose information (e.g., child safety) beyond their scope.

Training \& Mentoring in FN: Navigators will hold an undergraduate degree in a relevant field (e.g., social work), complete advanced MI training led by team members, and receive ongoing mentorship to maintain proficiency. Their intensive MI training and mentorship will set them apart from POM clinicians who do not receive MI support at the 3 sites. Each navigator will complete ~80h of MI training (e.g., readings, workshop) to maintain competence, starting with a 2-day virtual, interactive workshop on equity, diversity, inclusion, and accessibility, and including strategies to mitigate obesity bias and stigma. Through training, navigators will gain perspective and expertise on children and families from diverse backgrounds.

Usual Care: The control intervention is Usual Care for POM, delivered across the 3 clinics by multidisciplinary teams that follow family-centered care principles and practices and the Canadian Pediatric Obesity Clinical Practice Guideline. None of the sites offer navigation services as part of Usual Care. At clinic presentation, children will complete a comprehensive health assessment to inform behavioral (diet, physical activity, sedentary habits, sleep) goal setting and subspecialty medical referrals, if needed. Children and caregivers regularly attend POM visits to maintain healthy changes. Physician appointments occur every 6 to 12 months, but more frequently with other clinicians (e.g., dietitian). Dose and duration of POM vary by family need, motivation, and illness severity. The 3 clinics offer 1-on-1 in-person and virtual care. Families attend most appointments in the first 3-6 months, with frequency decreasing over time.

Sample Size: The investigators will recruit 252 participants (126/group; 84/site; 42/group/site). This sample size will allow for the detection of ≥50% difference in group proportions; The investigators' feasibility RCT revealed ~2× higher attrition in the control group. It is assumed that there will be 24% attrition at 24 months post-baseline in the control group, with a type I error rate of 0.05 (one-sided) and 80% power.

Recruitment Plan: Research assistants will collaborate with clinic staff to share study details with families at enrollment. Recruitment will span approximately 30 months, with ~9 participants enrolled per month across 3 sites until total sample size is achieved.

Number of Centers: The trial includes 3 multidisciplinary POM clinics in Calgary (Alberta Children's Hospital), Mississauga (Trillium Health Partners), and Ottawa (Children's Hospital of Eastern Ontario).