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.

BACKGROUND: Pediatric obesity management can be successful, but some families discontinue care prematurely (i.e., attrition), limiting treatment impact. Attrition is often a consequence of barriers and constraints that limit families' access to obesity management. Family Navigation (FN) can improve access, satisfaction with care, and treatment outcomes in diverse areas of healthcare. To help our team prepare for a future effectiveness trial, the objectives of our randomized feasibility study are to (i) explore children's and caregivers' acceptability of FN and (ii) examine attrition, measures of study rigor and conduct, and responses to FN + Usual Care vs Usual Care by collecting clinical, health services, and health economic data. METHODS: In our 2.5-year study, 108 6-17-year-olds with obesity and their caregivers will be randomized (1:1) to FN + Usual Care or Usual Care after they enroll in obesity management clinics in Calgary and Mississauga, Canada. Our Stakeholder Steering Committee and research team will use Experience-Based Co-Design to design and refine our FN intervention to reduce families' barriers to care, maximizing the intervention dose families receive. FN will be delivered by a navigator at each site who will use logistical and relational strategies to enhance access to care, supplementing obesity management. Usual Care will be offered similarly at both clinics, adhering to expert guidelines. At enrollment, families will complete a multidisciplinary assessment, then meet regularly with a multidisciplinary team of clinicians for obesity management. Over 12 months, both FN and Usual Care will be delivered virtually and/or in-person, pandemic permitting. Data will be collected at 0, 3, 6, and 12 months post-baseline. We will explore child and caregiver perceptions of FN acceptability as well as evaluate attrition, recruitment, enrolment, randomization, and protocol integrity against pre-set success thresholds. Data on clinical, health services, and health economic outcomes will be collected using established protocols. Qualitative data analysis will apply thematic analysis; quantitative data analysis will be descriptive. DISCUSSION: Our trial will assess the feasibility of FN to address attrition in managing pediatric obesity. Study data will inform a future effectiveness trial, which will be designed to test whether FN reduces attrition. TRIAL REGISTRATION: This trial was registered prospectively at ClinicalTrials.gov (# NCT05403658 ; first posted: June 3, 2022).

A survey of stakeholders' perceived importance of health indicators and subgroup analyses to inform the Canadian clinical practice guideline for managing paediatric obesity.

OBJECTIVE: To assess stakeholder ratings of health indicators and subgroup analyses in systematic reviews used to update the Canadian Clinical Practice Guideline for Managing Paediatric Obesity. METHODS: Stakeholders (caregivers of children with obesity and Clinical Practice Guideline Steering Committee members) completed an online survey between April 2020 and March 2021. Participants rated importance of health indicators and subgroup analyses for behavioural and psychological, pharmacotherapeutic, and surgical interventions for managing paediatric obesity from not important to critically important using Grading, Recommendations, Assessment, Development and Evaluation criteria. RESULTS: No health indicators or subgroup analyses were rated not important by the 30 caregivers and 17 Steering Committee members. Across intervention types, stakeholders rated anxiety, depression, health-related quality of life, serious adverse events, plus age and weight status subgroups as critically important. CONCLUSION: Stakeholder ratings will inform data reporting and interpretation to update Canada's Clinical Practice Guideline for Managing Paediatric Obesity.

Updating the Canadian clinical practice guideline for managing pediatric obesity: a protocol.

BACKGROUND: Since the first national guideline for managing obesity in adults and children in Canada was published in 2007, new evidence has emerged and guideline standards have evolved. Our purpose is to describe the protocol used to update the Canadian clinical practice guideline for managing pediatric obesity. METHODS: This guideline will update the pediatric components of the 2007 Canadian clinical practice guideline for the management of obesity. In partnership with Obesity Canada, we began preliminary work in 2019; activities are scheduled for completion in 2022. The guideline will follow standards developed by the National Academy of Medicine and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group. Guideline development will be informed by 5 complementary literature reviews: a scoping review that focuses on clinical assessment in pediatric obesity management and 4 systematic reviews to synthesize evidence regarding families' values and preferences as well as the safety and effectiveness of interventions (psychological and behavioural; pharmacotherapeutic; and surgical). We will use standard systematic review methodology, including summarizing and assessing the certainty of evidence and determining the strength of recommendations. Competing interests will be managed proactively according to recommendations from the Guidelines International Network. Diverse stakeholders, including families and clinicians, will be engaged throughout guideline development. INTERPRETATION: The guideline will support Canadian families and clinicians to make informed, value-sensitive and evidence-based clinical decisions related to managing pediatric obesity. The guideline and accompanying resources for end-users will be published in English and French, and we will partner with Obesity Canada to optimize dissemination using integrated and end-of-project knowledge translation.