Clinical trial NCT05403658: Attrition in Pediatric Obesity Management
Official title: Attrition in Pediatric Obesity Management: A Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Obesity
Keywords: child obesity
clinical care
attrition
childhood obesity
weight management
pediatric
barriers
patient navigation
family navigator
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Background: Pediatric obesity is prevalent, persistent, and complex. Annual obesity-linked healthcare costs in Canada exceed $7 billion. For people living with obesity, successful obesity management (i.e., reducing or stabilizing weight gain, improving obesity-related consequences) is challenging. Without intervention, obesity and its consequences usually track into adulthood, a pattern that entrenches with increasing obesity severity, underscoring the high value of accessible and effective interventions. Robust evidence demonstrates that multidisciplinary interventions centered on family lifestyle and behavior can help children to manage obesity. However, success is predicted by adhering to treatment regimens, including regularly attending clinical appointments. Effective lifestyle and behavioral interventions require a moderate to high intervention dose (\>25 hours of clinic contact over 6-12 months) to optimize benefits (↓BMI, systolic blood pressure; ↑insulin sensitivity, quality of life). Achieving this dose is difficult for families in pediatric obesity management (POM) because many experience barriers and constraints to accessing care, such as schedule availability, transportation costs, and variable motivation. Even the best obesity management interventions are undermined when families discontinue care prematurely. To meet this mandate, the proposed research tackles a common and vexing issue in POM - Attrition.

Purpose: The purpose of this feasibility study is to prepare the study team for a definitive RCT in which the investigators will test the effectiveness of a novel intervention (Family Navigation \[FN\]) to reduce attrition in 6-17 years old in pediatric obesity management (POM).

Objectives: The primary objectives of the study are to 1) assess children's and caregivers' perceived acceptability of the FN intervention and 2) evaluate attrition and measures of study rigor and conduct, including participant recruitment and enrolment, randomization procedures, and study protocol integrity, against pre-set success indicators. The study's secondary objective is to collect various outcomes (clinical, health services, economics) with established or possible links to attrition for descriptive purposes and hypothesis generation.

Trial Design: The trial is a 2.5-year, multi-method, multi-center randomized feasibility study that has 2 arms and follows parallel assignment. Children will be assigned to an experimental or control group after they enroll in multidisciplinary POM clinics in Calgary, AB and Mississauga, ON (Canada).

Trial Interventions: The experimental group will receive FN + Usual Care. FN will be co-designed to reduce attrition by managing barriers and eliminating constraints that limit access to care. FN increases access to a moderate to high intervention dose, increasing success in POM. The control group will receive Usual Care only (delivered similarly in the 2 study clinics).

Co-designing Family Navigation, a child- and family-centered intervention: Over the past decade, the investigators collected and synthesized qualitative and quantitative data on attrition from hundreds of families and clinicians. Equipped with this knowledge and experience, the investigators now apply it, working in partnership with the study Steering Committee (SC) to continue co-designing the FN intervention. The trial's participatory approach draws on key elements of Experience-Based Co-Design, an orientation that focuses on understanding SC members' experiences with health services, identifying potential improvements, and making changes together. With co-design, the investigators plan to increase intervention relevance and appropriateness, bringing together people who possess experiential knowledge (children, caregivers) with people who have expert knowledge (clinicians, researchers); the 2 knowledge systems enrich each other. The investigators have substantial experience in co-designing and refining health services and interventions in partnership with stakeholders; the current study extends the research team's legacy of collaborative, engaged research.

SC organization: The SC structure and values align with expert recommendations for stakeholder-engaged research. From the 2 POM clinics, the investigators will recruit 3 13-to 17-year-olds and 3 caregivers with first-hand experience in managing obesity, 3 clinicians working in POM, and one clinic manager, all of whom will join the research team members on the committee.

Delivering FN: The SC will optimize FN delivery, determining the most practical and important elements, a critical task for future scalability and sustainability. Each of the 2 study clinics will have a navigator to deliver FN. Navigators will be trained and equipped with resources for individualized support to benefit families in POM. Navigators will start by orienting families to the intervention and completing a detailed needs assessment, highlighting areas for support to manage barriers and remove constraints to POM access. Navigators will access a bundle of logistical and relational strategies to help families remove constraints or manage barriers in access to POM care. These multiple evidence-based strategies emerged from the investigators' attrition research with families and clinicians, but none are provided currently in our 2 clinics.

Logistical Strategies in FN:

* Communication via text message. Navigators will connect with families by study-dedicated smartphones to schedule appointments (book, remind, coordinate care), celebrate successes, troubleshoot barriers and constraints to care and share educational resources.
* Flexible navigator appointments. Beyond their POM visits, families and navigators will meet at convenient times, including evenings and weekends. Most appointments will be virtual (videoconference, phone), with in-person visits returning during the study term, pandemic permitting.
* Parking/Transit passes (up to 16 for in-person clinic visits). Passes will be used for any in-person visits of families with navigators and POM clinicians (or researchers).
* Community-based resources. Navigators will build a list of resources and services (e.g., mental health support, school-based programs) for families in Calgary and Mississauga.

Relational Strategies in FN: Navigators will use motivational interviewing (MI) principles, a directive, client-centered counseling approach used in most navigation interventions. Navigators will focus on listening to and validating family challenges, exploring the desire to continue POM. In some cases, they will work intensively with families, liaising regularly with clinicians to integrate care. In other cases, they will interact with families exclusively. Family preferences and needs drive appointment frequency with navigators: weekly, biweekly, or monthly; virtual (videoconference or phone) or in-person, pandemic permitting; 30-60 min long. As a tailored intervention, FN acknowledges that the desire to maximize POM adherence varies by family and that ambivalence is common in managing obesity. Navigator-family discussions may include children and caregivers together or separately, based on preferences and needs. Navigators will adhere to a communication and documentation protocol if families disclose information (e.g., child safety) beyond their scope.

Usual Care: The control intervention is Usual Care for POM, delivered similarly across our 2 clinics by multidisciplinary teams who follow family-centered care principles and guidelines. At clinic presentation, children will complete a comprehensive health assessment to inform lifestyle (diet, physical activity, sedentary habits, sleep) and behavioral goal setting and subspecialty medical referrals, if indicated. Children and caregivers attend POM visits regularly to make and maintain healthy changes. Appointments with physicians occur at least every 6 months and more frequently with other clinicians (e.g., RD, Psych). The dose and duration of POM vary according to family need, motivation, and illness severity. The 2 study clinics offer 1-on-1 virtual care by videoconference or phone, with in-person visits restarting, pandemic permitting. Families attend most visits in their first 3-6 months, with appointment frequency decreasing over time, consistent with guidelines.

Sample Size: The investigators will recruit 108 participants (54/group; 54/site). Feasibility studies do not include formal sample size calculations, but experts recommend 12-36/arm. So, the investigators will enroll 27/arm/site.

Recruitment: Research assistants will work with clinical teams to give families details about the study at clinic enrolment. The research team expects families to have an interest in this study because they have the potential to benefit directly from study participation via FN. Recruitment will span \~12 months.

Number of Centers: The study has 2 multidisciplinary, Canadian POM clinic sites: Calgary, AB (Alberta Children's Hospital) and Mississauga, ON (Trillium Health Partners).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Perceived acceptability of Family Navigation (Child)
timeFrame: 3, 6, and 12 months post-baseline
measure: Perceived acceptability of Family Navigation (Caregiver)
timeFrame: 3, 6, and 12 months post-baseline
Secondary outcomes:
measure: Sociodemographic data
timeFrame: Baseline
measure: Measures of study rigor and conduct
timeFrame: Baseline
measure: Attrition
timeFrame: 3, 6, and 12 months post-baseline
measure: PedsQL
timeFrame: Baseline, 3, 6, and 12 months post-baseline
measure: Child- and caregiver-reported internalized and experienced weight bias
timeFrame: Baseline, 3, 6, and 12 months post-baseline
measure: Working Alliance Inventory
timeFrame: Baseline, 3, 6, and 12 months post-baseline
measure: Family treatment expectations for obesity management
timeFrame: Baseline
measure: Child and caregiver motivation to change lifestyle habits
timeFrame: Baseline, 3, 6, and 12 months post-baseline
measure: PedsQL Healthcare Satisfaction
timeFrame: Baseline, 3, 6, and 12 months post-baseline
measure: Unintended consequences of treatment
timeFrame: Baseline, 3, 6, and 12 months post-baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Geoff Ball, PhD RD
role: PRINCIPAL_INVESTIGATOR
References: