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      Protocol for the measurement of changes in knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND))

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          Abstract

          Background

          Community-based interventions have shown promise in addressing the childhood obesity epidemic. Such efforts rely on the knowledge of key community members and their engagement with the drivers of obesity in their community. This paper presents the protocol for the measurement and evaluation of knowledge and engagement among community leaders within a whole-of-community systems intervention across 10 large intervention communities in Australia.

          Methods

          We will investigate the role of stakeholder knowledge and engagement in the implementation and effectiveness of the stepped wedge cluster randomised trial in ten communities in Victoria, Australia. Data will be collected using the Stakeholder-driven Community Diffusion Survey (SDCD) to measure levels of knowledge and engagement prior to commencement (2019), across the three separate levels of governance within the intervention at five time points. Primary outcomes will be baseline overall knowledge and engagement scores across the three levels of governance and change in overall knowledge and engagement over time.

          Discussion

          We hypothesise there will be heterogeneity between intervention sites on levels of knowledge and engagement and that these differences will be associated with variability in implementation success.

          Trial registration

          Australian New Zealand Clinical Trials Registry ACTRN12618001986268. Registered on 11 December 2018

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          Most cited references25

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          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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            The Global Syndemic of Obesity, Undernutrition, and Climate Change: The Lancet Commission report

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              Predicting adult obesity from childhood obesity: a systematic review and meta-analysis.

              A systematic review and meta-analysis was performed to investigate the ability of simple measures of childhood obesity such as body mass index (BMI) to predict future obesity in adolescence and adulthood. Large cohort studies, which measured obesity both in childhood and in later adolescence or adulthood, using any recognized measure of obesity were sought. Study quality was assessed. Studies were pooled using diagnostic meta-analysis methods. Fifteen prospective cohort studies were included in the meta-analysis. BMI was the only measure of obesity reported in any study, with 200,777 participants followed up. Obese children and adolescents were around five times more likely to be obese in adulthood than those who were not obese. Around 55% of obese children go on to be obese in adolescence, around 80% of obese adolescents will still be obese in adulthood and around 70% will be obese over age 30. Therefore, action to reduce and prevent obesity in these adolescents is needed. However, 70% of obese adults were not obese in childhood or adolescence, so targeting obesity reduction solely at obese or overweight children needs to be considered carefully as this may not substantially reduce the overall burden of adult obesity.
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                Author and article information

                Contributors
                jill.whelan@deakin.edu.au
                Claudia.strugnell@deakin.edu.au
                Steven.allender@deakin.edu.au
                Ariella.Korn@tufts.edu
                Andrew.brown@deakin.edu.au
                Liliana.orellana@deakin.edu.au
                Victoria.brown@deakin.edu.au
                Anna.peeters@deakin.edu.au
                Marj.moodie@deakin.edu.au
                Melanie.nichols@deakin.edu.au
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                4 September 2020
                4 September 2020
                2020
                : 21
                : 763
                Affiliations
                [1 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Institute for Health Transformation, Global Obesity Centre, , Deakin University, ; Geelong, Australia
                [2 ]GRID grid.429997.8, ISNI 0000 0004 1936 7531, Friedman School of Nutrition Science and Policy, , Tufts University, ; Boston, USA
                [3 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Biostatistics Unit, , Deakin University, ; Geelong, Australia
                [4 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Institute for Health Transformation, Deakin Health Economics, , Deakin University, ; Geelong, Australia
                [5 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Institute for Health Transformation, School of Health and Social Development, , Deakin University, ; Geelong, Australia
                Author information
                http://orcid.org/0000-0001-9434-109X
                Article
                4692
                10.1186/s13063-020-04692-6
                7650215
                32887655
                b7c1309c-ba57-441d-8524-e5f1b082e85d
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 25 October 2019
                : 16 August 2020
                Funding
                Funded by: National Medical and Health Research Council Australia
                Award ID: APP1151572
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100007220, VicHealth;
                Award ID: n/a
                Award Recipient :
                Funded by: Nexus Primary Health
                Award ID: n/a/
                Award Recipient :
                Funded by: Goulburn Valley Primary Care Partnership
                Award ID: n/a
                Award Recipient :
                Funded by: Victorian Department of Health and Human Services
                Award ID: n/a
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine
                Medicine

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