Browsing by Author "Buchholz, Annick"
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Item Open Access 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(2023-01-23) Ball, Geoff D. C.; O’Neill, Marcus G.; Noor, Rafat; Alberga, Angela; Azar, Rima; Buchholz, Annick; Enright, Michelle; Geller, Josie; Ho, Josephine; Holt, Nicholas L.; Lebel, Tracy; Rosychuk, Rhonda J.; Tarride, Jean-Eric; Zenlea, IanAbstract 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).Item Open Access Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial(2020-02-03) Mâsse, Louise C; Vlaar, Janae; Macdonald, Janice; Bradbury, Jennifer; Warshawski, Tom; Buckler, E. J; Hamilton, Jill; Ho, Josephine; Buchholz, Annick; Morrison, Katherine M; Ball, Geoff D CAbstract Background The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable alternative to in-person interventions for behavior change, especially with teens. Purpose The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to 1) test whether supplementing the Aim2Be program with health coaching increases adherence and 2) examine the mediators and moderators of adherence to the Aim2Be intervention. Methods We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019–2020). Participants will be recruited from Canadian pediatric weight management clinics and through online advertisements. Child participants must be between the ages of 10 and 17 years, have overweight or obesity, be able to read English at least at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. After having their data collected for 3 months, the control group will gain access to Aim2Be, with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy. Discussion Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviors and guide future mHealth interventions for pediatric weight management. Trial registration ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.Item Open Access The CANadian Pediatric Weight management Registry (CANPWR): lessons learned from developing and initiating a national, multi-centre study embedded in pediatric clinical practice(2018-07-19) Morrison, Katherine M; Ball, Geoff D C; Ho, Josephine; Mackie, Pam; Buchholz, Annick; Chanoine, Jean-Pierre; Hamilton, Jill; Laberge, Anne-Marie; Legault, Laurent; Thabane, Lehana; Tremblay, Mark; Zenlea, IanAbstract Background There is increasing recognition of the value of “real-world evidence” in evaluating health care services. Registry-based, observational studies conducted in clinical settings represent a relevant model to achieve this directive. Starting in 2010, we undertook a longitudinal, observational study (the CANadian Pediatric Weight management Registry [CANPWR]), which is embedded in 10 multidisciplinary, pediatric weight management clinics across Canada. The objective of this paper was to share the lessons our team learned from this multi-centre project. Methods Data sources included a retrospective review of minutes from 120 teleconferences with research staff and investigators, notes taken during clinical site visits made by project leaders, information from quality control processes to ensure data accuracy and completeness, and a study-specific survey that was sent to all sites to solicit feedback from research team members (n = 9). Through an iterative process, the writing group identified key themes that surfaced during review of these information sources and final lessons learned were developed. Results Several key lessons emerged from our research, including the (1) value of pilot studies and central research coordination, (2) need for effective and regular communication, (3) importance of consensus on determining outcome measures, (4) challenge of embedding research within clinical practice, and (5) difficulty in recruiting and retaining participants. The sites were, in spite of these challenges, enthusiastic about the benefits of participating in multi-centre collaborative studies. Conclusion Despite some challenges, multi-centre observational studies embedded in pediatric weight management clinics are feasible and can contribute important, practical insights into the effectiveness of health services for managing pediatric obesity in real-world settings.