Applying Navigation and Care to Help Ongoing Retention
ConditionChild Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be 6-17 years old,
have a BMI ≥97th percentile,
have a primary caregiver (parent/guardian) agree to participate
Disqualifiers
participants will be excluded if caregivers cannot communicate in English since the Family Navigation intervention will be available in English only.
Trial design
Design model
Parallel
Treatments tested in this trial
Family Navigation
BehavioralFN 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
BehavioralUsual 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.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: Family Navigation + Usual CareExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-baselineSecondary outcomes
1
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
Baseline2
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-baseline3
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-baseline4
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-baselineSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: