Applying Navigation and Care to Help Ongoing Retention

NCT07834632 | Not Yet Recruiting

• 1 other identifier: Pro00169417
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Obesity

Keywords

child obesity; clinical care; attrition; childhood obesity; weight management; pediatric; barriers; patient navigation; family navigation; family navigator

Outcome Measures

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.

  24 months post-baseline

Secondary Outcomes (12)

• Sociodemographic Data

  Baseline

• Anthropometrics

  At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline

• Health-related Quality of Life (PedsQL 4.0)

  At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline

• Health-related Quality of Life (HUI-3)

  At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline

• Internalized and Experienced Weight Bias

  At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline

Study Arms (2)

Family Navigation + Usual Care

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Participants assigned to this arm will standard pediatric obesity management only.

Behavioral: Usual Care

Interventions

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.

Family Navigation + Usual Care

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.

Family Navigation + Usual Care; Usual Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity; Tooth Wear

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Geoff Ball, PhD RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus O'Neill, MSc RD

CONTACT

780-996-6697; mgoneill@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)