An interventional study of Family Navigation and Usual Care in Child Obesity, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Alberta · Not applicable, Interventional, and Health services research
Canada's health care system has established numerous clinics over the past 20 years to treat childhood obesity. However, up to 80% of children at these clinics drop out before they finish treatment. This is one of the most difficult challenges in managing childhood obesity, since even the most effective treatments cannot help children who drop out. However, children who stay in treatment longer are more likely to manage obesity successfully. This randomized controlled trial will test whether Family Navigation (FN) helps reduce drop out from obesity treatment. Overall, this study will last 5 years. The investigators will enroll 252 children aged 6 to 17 with obesity. These children will receive treatment at obesity management clinics in Calgary, Mississauga, or Ottawa. For the 24-month intervention period, one group of children (half of those enrolled) will receive FN + Usual Care; the other group will receive only Usual Care. Navigators trained in motivational interviewing and bias/stigma reduction will work with children receiving FN and their families to overcome barriers that limit their access to health services and support. Navigators will offer additional services and resources, such as parking passes for clinic visits and supportive text messages between appointments. FN is designed to support the obesity management care received by children and their families. Better access to care may help children and their families working with navigators to stay engaged and attend more treatment appointments. Ultimately, they may be more likely to succeed in managing obesity.
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).
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 252 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive the Family Navigation (FN) intervention in addition to standard pediatric obesity management (Usual Care).
Behavioral: Family Navigation · Behavioral: Usual Care
Participants assigned to this arm will standard pediatric obesity management only.
Behavioral: Usual Care
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 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.
Attrition
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.
Time frame: 24 months post-baseline
Sociodemographic Data
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.
Time frame: Baseline
Anthropometrics
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.
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Health-related Quality of Life (PedsQL 4.0)
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.
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Health-related Quality of Life (HUI-3)
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.
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Internalized and Experienced Weight Bias
Survey to assess child- and caregiver-reported internalized and experienced weight bias
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Strength of Therapy Relationship Between Caregivers and Navigators/Clinicians
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.
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Pediatric Obesity Management Influence on Children's Perceived Health
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).
Time frame: At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline
Quality of Care Received
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).
Time frame: At 6-, 12-, 18-, and 24-months post-baseline
Unintended Consequences
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.
Time frame: At 6-, 12-, 18-, and 24-months post-baseline
Health Services Usage
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.
Time frame: At 6-, 12-, 18-, and 24-months post-baseline
Incremental cost per quality adjusted life years (QALYs) gained
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).
Time frame: At 6-, 12-, 18-, and 24-months post-baseline
Intervention Implementation
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.
Time frame: 12- and 24-months post-baseline
Plan to share: No
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