NCT05403658

Attrition in Pediatric Obesity Management

Active, enrolled NA Last updated 8 January 2026

What this trial tests

NA trial testing Family Navigation in Child Obesity in 108 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 October 2022

Primary endpoint
30 May 2024

31 August 2026

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	108
Start date	14 October 2022
Primary completion	30 May 2024
Estimated completion	31 August 2026
Sites	1 location across Canada

Drugs / interventions tested

• Family Navigation
• Usual Care

Conditions studied

• Child Obesity — all drugs for Child Obesity →

Sponsor

University of Alberta

Who can join

Adults 6 to 17, any sex, with Child Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol.
   Ball GDC, O'Neill MG, Noor R, Alberga A, et al · · 2023 · cited 2× · PMID 36691103 · DOI 10.1186/s40814-023-01246-w
2. A multi-centre, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: A study protocol
   Ball G, O’Neill MG, Noor R, Alberga A, et al · · 2022 · DOI 10.21203/rs.3.rs-1813077/v1