Attrition in Pediatric Obesity Management
NCT05403658 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2026-01-08
Summary
Our feasibility study will assess the feasibility and acceptability of Family Navigation (FN) to address attrition (dropout) in pediatric obesity management. Results from this study will help our team to plan a large randomized clinical trial to test the effectiveness of FN in reducing attrition.
The investigators will enroll 108 6-to-17-year-olds enrolled in pediatric obesity management clinics in Calgary, AB and Mississauga, ON (Canada). One-half of the children will receive Family Navigation (FN) + Usual Care (UC) for 12 months; the other half will receive Usual Care only for 12 months. Overall, the study will take 2.5 years to complete.
For children receiving FN, trained navigators will work with children and their families to reduce barriers that limit their access to health services and support. Navigators will offer extra services and resources, such as parking passes for clinic appointments and supportive text messages between appointments. FN is designed to complement the obesity management (Usual Care) received by children and their families. A Steering Committee with children, caregivers, clinicians, and researchers will be created to refine and improve our FN intervention throughout the study.
By having better access to care, children and their families working with navigators may be less likely to drop out and more likely to attend more treatment appointments. Ultimately, the participants may be more likely to achieve success in managing obesity.
Conditions
- Child Obesity
Interventions
- BEHAVIORAL
-
Family Navigation
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.
- BEHAVIORAL
-
Usual Care
Usual Care is delivered similarly across the 2 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.
Sponsors & Collaborators
-
University of Alberta
lead OTHER
Principal Investigators
-
Geoff Ball, PhD RD · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-14
- Primary Completion
- 2024-05-30
- Completion
- 2026-08-31
Countries
- Canada
Study Locations
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