Evidence map›Paper›PMID 36691103›Full record

ArticlePilot and feasibility studies2023

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.

Geoff D C Ball, Marcus G O'Neill, Rafat Noor, Angela Alberga, Rima Azar, Annick Buchholz, Michelle Enright, Josie Geller, Josephine Ho, Nicholas L Holt and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05403658 (Attrition in Pediatric Obesity Management), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05403658 naactive not recruitingnot on this map

Attrition in Pediatric Obesity Management: A Randomized Feasibility Study

TypeinterventionalSponsorUniversity of AlbertaRan2022 to 2026Enrolled108ConditionsChild ObesityArmsFamily Navigation, Usual Care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Geoff D C BallDepartment of Pediatrics, University of Alberta, 4-515 Edmonton Clinic Health Academy, 11405 87th Ave, Edmonton, AB, T6G 1C9, Canada. gdball@ualberta.ca.ORCID http://orcid.org/0000-0002-9432-3120
Marcus G O'NeillDepartment of Pediatrics, University of Alberta, 4-515 Edmonton Clinic Health Academy, 11405 87th Ave, Edmonton, AB, T6G 1C9, Canada.
Rafat NoorDepartment of Pediatrics, University of Alberta, 4-515 Edmonton Clinic Health Academy, 11405 87th Ave, Edmonton, AB, T6G 1C9, Canada.
Angela AlbergaDepartment of Health, Kinesiology, and Applied Physiology, Concordia University, Montreal, QC, Canada.
Rima AzarPsychobiology of Stress & Health Lab, Department of Psychology, Mount Allison University, Sackville, NB, Canada.
Annick BuchholzDepartment of Psychology, Carleton University, Ottawa, ON, Canada.
Michelle EnrightWestview Primary Care Network, Spruce Grove, AB, Canada.
Josie GellerDepartment of Psychiatry, University of British Columbia, Vancouver, BC, Canada.
Josephine HoDepartment of Paediatrics, University of Calgary, Calgary, AB, Canada.
Nicholas L HoltFaculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.
Tracy LebelPatient and Family Partner, Edmonton, AB, Canada.
Rhonda J RosychukDepartment of Pediatrics, University of Alberta, 4-515 Edmonton Clinic Health Academy, 11405 87th Ave, Edmonton, AB, T6G 1C9, Canada.
Jean-Eric TarrideDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Ian ZenleaDepartment of Pediatrics, University of Toronto, Toronto, ON, Canada.

Funding

CIHR 462972
6 · The paper itself

Abstract

backgroundPediatric 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.

methodsIn 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 registrationThis trial was registered prospectively at ClinicalTrials.gov (# NCT05403658 ; first posted: June 3, 2022).

Indexed as

AttritionCanadaChronic Disease ManagementFeasibility studyObesityPediatricRandomized trial

Identifiers

PMID36691103
PMCPMC9868519

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.