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).

• Family Navigation (Behavioral): FN will be delivered by navigators who will provide support and services that complement obesity management care provided by multidisciplinary teams at the study clinical sites. With advanced training in motivational interviewing and patient- / family-centered care, navigators will access a bundle of logistical and relational strategies to help families derive the greatest possible benefit from their care, which will include working to reduce barriers to care, improve access, and optimize treatment outcomes related to obesity management that is part of their Usual Care. Navigators will provide various resources/supports to study participants including, but not limited to, offering communication via text message, flexible navigator appointments, parking/transit passes, community-based resources, and liaising with members of the multidisciplinary clinical teams at each site.
• Usual Care (Behavioral): Usual Care is delivered similarly across the 3 clinical sites. Obesity management is offered by multidisciplinary teams that include clinicians with advanced expertise in pediatrics, nutrition, mental health, physical activity/exercise, and behavior change. Interventions are tailored to families' readiness, capabilities, and motivation to make healthy lifestyle and behavioral changes.

Primary outcomes

• Attrition [24 months post-baseline]: Complementing the investigators' conceptual definition of attrition (permanent discontinuation of care), the operational definition includes "yes" and "no" categories. Attrition will be recorded identically for experimental (FN + Usual Care) and control (Usual Care only) groups at all 3 sites. A child will be classified as "yes" if they discontinue POM within 24 months post-baseline or miss/cancel an appointment without rescheduling, and the clinic has no follow-up with the family after 4 communication attempts over 4 weeks and no upcoming appointments scheduled. A child in POM at 24-months post-baseline will be classified as "no." Attrition will be marked as the exact date of a child's last recorded interaction with a POM clinician or navigator, confirmed using primary (medical records, scheduling system) and secondary (families, POM clinicians, navigators \[experimental group only\]) sources.

Secondary outcomes

• Sociodemographic Data [Baseline]: The investigators will collect child and caregiver birth dates, relationship, ethnicity/cultural backgrounds, and socioeconomic status via self-report from families. Child and caregiver sex and gender, according to Statistics Canada definitions, will also be documented.
• Anthropometrics [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: The investigators will measure children's weight (nearest 0.1 kg) and height (nearest 0.1 cm), then calculate body mass index (BMI; kg/m2), BMI z-score (BMIz), and BMI percentile.
• Health-related Quality of Life (PedsQL 4.0) [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: The investigators will measure health-related quality of life via self-reports by children and proxy reports by caregivers using the Pediatric Quality of Life Inventory (PedsQL) 4.0. Scores can range from 0-100, with higher scores indicating higher health-related quality of life.
• Health-related Quality of Life (HUI-3) [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: The Health Utility Index Mark 3 (HUI-3) measures health-related quality of life across the following domains; Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. Each domain is scored (range 0 to 1). Higher scores indicate a higher quality of life for that domain.
• Internalized and Experienced Weight Bias [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: Survey to assess child- and caregiver-reported internalized and experienced weight bias
• Strength of Therapy Relationship Between Caregivers and Navigators/Clinicians [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: The investigators will use the Working Alliance Inventory survey to quantify the strength of therapy relationship between caregivers and navigators/clinicians. Survey scores will range from 12-60, with higher scoring indicating a stronger relationship.
• Pediatric Obesity Management Influence on Children's Perceived Health [At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline]: Pediatric Weight Questionnaire to assess POM influence on children's perceived physical, emotional, and social health. There are 3 versions of the questionnaire, depending on the child's age (6-7y, 8-11y \& 12-17y). Results will be reported using proportional scores (e.g., % Always, % Often, % Sometimes, % Rarely and % Never).
• Quality of Care Received [At 6-, 12-, 18-, and 24-months post-baseline]: Caregivers will rate the quality of care their family received using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Surveys. Results to survey questions will be reported using frequencies, top box scores, and other proportional scores (e.g., % Always, % Usually, and % Never and Sometimes).
• Unintended Consequences [At 6-, 12-, 18-, and 24-months post-baseline]: Survey to assess unintended intervention effects (harms and benefits) related to POM using a case report form developed for the investigators' feasibility RCT. The list of effects was informed by a recent meta-analysis by team members on effectiveness and safety of behavioral POM interventions.
• Health Services Usage [At 6-, 12-, 18-, and 24-months post-baseline]: Research assistants will retrieve data from on-site electronic scheduling systems and children's medical records using case report forms from the investigators' feasibility RCT. Data collected from both groups will include appointment frequency (count), type (e.g., navigator, physician), mode (e.g., videoconference, in-person), duration (15-min intervals), and changes (cancelled, missed). These data track intervention type and dose received, which may differ between groups if FN improves access to POM (i.e., reduce attrition and increase intervention dose). Data will also be gathered on obesity medication type (e.g., GLP-1), dose, and duration, which may impact follow-up care or health care use.
• Incremental cost per quality adjusted life years (QALYs) gained [At 6-, 12-, 18-, and 24-months post-baseline]: Costs will be estimated for all relevant activities for both experimental and control groups, including FN intervention preparation (e.g., mentoring navigators), intervention delivery (e.g., session frequency), health care resource use (e.g., physician appointments), and productivity loss (e.g., work absence for travel).
• Intervention Implementation [12- and 24-months post-baseline]: Quantitative Implementation data will include a study-specific exit survey for children (10-17y only) and caregivers to document the support they received from navigators. For qualitative implementation data collection, 30-minute semi-structured, 1-on-1 interviews will be completed with the families in the experimental group (FN + Usual Care). The interview is developed using the Theoretical Framework of Acceptability explores 7-domains related to acceptability (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self efficacy). The sampling will use age as a proxy for developmental stage (6-9y, 10-13y, 14-17y). For the 6-9y group, only caregivers will be interviewed. Children and caregivers will be interviewed independently. Surveys and interviews at 12 months will include only eligible families who discontinued care within the first year, ensuring data reflects their recent experiences and perceptions.

Sex: All, ages: 6 Years to 17 Years

Inclusion Criteria:

* be 6-17 years old,
* have a BMI ≥97th percentile,
* have a primary caregiver (parent/guardian) agree to participate

Exclusion Criteria:

* participants will be excluded if caregivers cannot communicate in English since the Family Navigation intervention will be available in English only.

• Geoff Ball, PhD RD, Principal investigator, University of Alberta