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      Study protocol for Healthy Conversations @ Playgroup: a multi-site cluster randomized controlled trial of an intervention to promote healthy lifestyle behaviours in young children attending community playgroups

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          Abstract

          Background

          Early childhood is a critical window for preventing obesity and chronic disease. Yet, 1 in 4 Australian children aged 5 years and under are affected by overweight or obesity; and significant proportions of children under 5 years fail to meet guidelines for diet quality, physical activity (PA), screen time, and sleep. Consequently, effective interventions to promote healthy lifestyle behaviors and prevent obesity during early childhood are needed. Community playgroups provide an opportunity for parents, carers, and children to meet in a safe and relaxed environment to play and share information. The structure, low cost and reach of playgroups provide a unique platform to engage parents in a scalable program to promote healthful lifestyle behaviors and prevent childhood obesity. However, the evidence base for the effectiveness of health promotion programs delivered in community playgroup settings is limited and lacking credible evidence from rigorously conducted randomized controlled trials.

          Methods

          The Healthy Conversations @ Playgroup randomized controlled trial (RCT) aims to address the underlying behavioral risk factors for obesity by helping parents take effective steps to improve their child’s dietary, PA, screen time, and sleep behaviors. The intervention program comprises 10 “healthy conversations” led by a trained peer facilitator, designed to increase parents’ behavioral capability and self-efficacy to implement autonomy-supportive parenting practices. The program will be delivered biweekly during regularly scheduled playgroup sessions over 10-weeks. Effectiveness will be tested in a 2-arm cluster RCT involving 60 community playgroups in three states across Australia. After baseline assessments, participating playgroups will be randomly allocated to either intervention or wait-list control conditions. Primary outcomes (vegetable intake, discretionary foods, daily PA, screen time, sleep duration, and body mass index [BMI] z-score) will be assessed at baseline, immediately post-intervention (10-weeks; T2) and 6-months post-intervention (T3). Outcomes will be assessed for differential change at T2 and T3.

          Discussion

          The Healthy Conversations @ Playgroup trial will rigorously evaluate a novel peer-led intervention program to promote healthful lifestyle behaviors and prevent obesity in children and families attending community playgroups. If effective, the program could be immediately scaled-up and delivered in community playgroups across Australia.

          Trial registration

          Trial registered 22nd January 2021 with the Australian and New Zealand Clinical Trials Registry ( ACTRN12621000055808).

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12889-021-11789-3.

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          Most cited references36

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          The REDCap consortium: Building an international community of software platform partners

          The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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            The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions.

            CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. "BCT taxonomy v1," an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus.
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              Social Foundations of Thought and Action : A Social Cognitive Theory

              Presents a comprehensive theory of human motivation and action from a social-cognitive perspective. This insightful text addresses the prominent roles played by cognitive, vicarious, self-regulatory, and self-reflective processes in psychosocial functioning; emphasizes reciprocal causation through the interplay of cognitive, behavioral, and environmental factors; and systematically applies the basic principles of this theory to personal and social change.
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                Author and article information

                Contributors
                s.trost@qut.edu.au
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                26 September 2021
                26 September 2021
                2021
                : 21
                : 1757
                Affiliations
                [1 ]GRID grid.1024.7, ISNI 0000000089150953, Faculty of Health, , School of Exercise and Nutrition Science, Queensland University of Technology at the Centre for Children’s Health Research (CCHR), ; South Brisbane, Queensland Australia
                [2 ]GRID grid.1024.7, ISNI 0000000089150953, Faculty of Education, , School of Early Childhood and Inclusive Education, Queensland University of Technology, ; Kelvin Grove, Queensland Australia
                [3 ]GRID grid.1014.4, ISNI 0000 0004 0367 2697, College of Nursing and Health Sciences, , Caring Futures Institute, Flinders University, ; Bedford Park, South Australia Australia
                [4 ]GRID grid.414659.b, ISNI 0000 0000 8828 1230, Telethon Kids Institute, ; Nedlands, Western Australia Australia
                [5 ]GRID grid.453171.5, ISNI 0000 0004 0380 0628, Health and Wellbeing Queensland, Queensland Government, ; Milton, Queensland Australia
                Author information
                http://orcid.org/0000-0001-9587-3944
                Article
                11789
                10.1186/s12889-021-11789-3
                8474833
                34565369
                c62ff8dd-2602-4946-99d5-19df293c3627
                © The Author(s) 2021

                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
                : 13 September 2021
                : 15 September 2021
                Funding
                Funded by: Medical Research Future Fund
                Award ID: APP1200764
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2021

                Public health
                obesity,childhood,diet,physical activity,screen time,sleep
                Public health
                obesity, childhood, diet, physical activity, screen time, sleep

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