Attrition in Pediatric Obesity Management

NCT05403658 | Active Not Recruiting

• 1 other identifier: Pro00111932
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Perceived acceptability of Family Navigation (Child)

  The investigators will complete semi-structured, 1-on-1 interviews with children using appropriate interview guides. Guides are based on multiple domains of intervention acceptability according to the Theoretical Framework of Acceptability, which includes multiple component constructs. Our sampling uses age as a proxy for developmental stage (6-9y; 10-13y; 14-17y). Groupings were based on developmental differences that could influence participants' perceptions and experiences of the Family Navigation intervention. Children from (10-13y) and (14-17y) age groups will be interviewed. For the 6-9y group, no children will be interviewed; however, their caregivers will be interviewed. Interviews will be recorded, undergo voice-to-text conversion, or be transcribed verbatim. Perceived acceptability among children will be measured in a sub-set of the families in the FN + UC group.

  3, 6, and 12 months post-baseline

• Perceived acceptability of Family Navigation (Caregiver)

  The investigators will complete semi-structured, 1-on-1 interviews with caregivers, using interview guides that are appropriate for them. Guides are based on multiple domains of intervention acceptability according to the Theoretical Framework of Acceptability, which includes multiple component constructs. Sampling for caregivers' interviews will be performed considering their children's age group. Our sampling uses the age of the children as a proxy for developmental stage (6-9y; 10-13y; 14-17y). Groupings were based on developmental differences that could influence participants' perceptions and experiences of the Family Navigation intervention. Interviews will be recorded, undergo voice-to-text conversion, or be transcribed verbatim. Perceived acceptability among children will be measured in a sub-set of the families in the FN + UC group.

  3, 6, and 12 months post-baseline

Secondary Outcomes (10)

• Sociodemographic data

  Baseline

• Measures of study rigor and conduct

  Baseline

• Attrition

  3, 6, and 12 months post-baseline

• PedsQL

  Baseline, 3, 6, and 12 months post-baseline

• Child- and caregiver-reported internalized and experienced weight bias

  Baseline, 3, 6, and 12 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

Usual Care BEHAVIORAL

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.

Family Navigation + Usual Care; Usual Care

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

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, T6G 2R3, Canada

Location

Related Publications (1)

• Ball GDC, O'Neill MG, Noor R, Alberga A, Azar R, Buchholz A, Enright M, Geller J, Ho J, Holt NL, Lebel T, Rosychuk RJ, Tarride JE, Zenlea I. 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. Pilot Feasibility Stud. 2023 Jan 23;9(1):14. doi: 10.1186/s40814-023-01246-w.

  PMID: 36691103 DERIVED

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study investigators will not know which families were randomized to the experimental group or control group. Data analyses, both quantitative and qualitative, will be led by investigators who will have no direct contact with families and will not have access to information regarding group assignment. Interventions will be delivered by Family Navigators and data collection will be completed by research team members, although both groups will be aware of families' group assignments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 3, 2022
• Study Start: October 14, 2022
• Primary Completion: May 30, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)