Attrition in Pediatric Obesity Management

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Perceived acceptability of Family Navigation (Child) — 3, 6, and 12 months post-baseline
  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.
• Perceived acceptability of Family Navigation (Caregiver) — 3, 6, and 12 months post-baseline
  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.

Trial sites (1)

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