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      Protocol for a gender-sensitised weight loss and healthy living programme for overweight and obese men delivered in Australian football league settings (Aussie-FIT): A feasibility and pilot randomised controlled trial

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          Abstract

          Introduction

          Overweight and obesity are highly prevalent among Australian men. Professional sports settings can act as a powerful ‘hook’ to engage men in weight loss programmes; the Football Fans in Training programme delivered in professional UK soccer clubs was successful and cost-effective in helping men lose weight. The Australian Football League (AFL) is a potentially attractive setting to engage men in a weight loss programme. We aim to develop, pilot and evaluate the feasibility of a weight loss intervention for overweight/obese middle-aged men, delivered in AFL settings, to promote weight loss and healthier lifestyles and determine its suitability for a future randomised control trial.

          Methods and analysis

          120 overweight/obese male fans will complete baseline physical and psychological health measures and objective measures of physical activity (PA), weight, waist size and blood pressure prior to randomisation into the intervention or waitlist comparison group. The intervention group will receive 12 weekly 90 min workshops incorporating PA, nutrition education, behaviour change techniques and principles of effective motivation. Four community coaches will be trained to deliver Aussie-FIT at two AFL clubs in Western Australia. Measurements will be repeated in both groups at 3 months (post-intervention) and 6 months (follow-up). Outcomes will include programme uptake, attendance, changes in lifestyle and weight variables to inform power calculations for a future definitive trial, fidelity of programme delivery, acceptability, satisfaction with the programme and perceptions of effectiveness. We will also determine trial feasibility and potential to gather cost-effectiveness data.

          Ethics and dissemination

          Ethics approval was granted by Curtin University’s Human Research Ethics Committee (HREC2017-0458). Results will be disseminated via peer-reviewed publications, conference presentations and reports. A multicomponent dissemination strategy will include targeted translation and stakeholder engagement events to establish strategies for sustainability and policy change.

          Trial registration number

          ACTRN12617000515392; Pre-results.

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          Most cited references36

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          Theoretical explanations for maintenance of behaviour change: a systematic review of behaviour theories

          ABSTRACT Background: Behaviour change interventions are effective in supporting individuals in achieving temporary behaviour change. Behaviour change maintenance, however, is rarely attained. The aim of this review was to identify and synthesise current theoretical explanations for behaviour change maintenance to inform future research and practice. Methods: Potentially relevant theories were identified through systematic searches of electronic databases (Ovid MEDLINE, Embase, PsycINFO). In addition, an existing database of 80 theories was searched, and 25 theory experts were consulted. Theories were included if they formulated hypotheses about behaviour change maintenance. Included theories were synthesised thematically to ascertain overarching explanations for behaviour change maintenance. Initial theoretical themes were cross-validated. Findings: One hundred and seventeen behaviour theories were identified, of which 100 met the inclusion criteria. Five overarching, interconnected themes representing theoretical explanations for behaviour change maintenance emerged. Theoretical explanations of behaviour change maintenance focus on the differential nature and role of motives, self-regulation, resources (psychological and physical), habits, and environmental and social influences from initiation to maintenance. Discussion: There are distinct patterns of theoretical explanations for behaviour change and for behaviour change maintenance. The findings from this review can guide the development and evaluation of interventions promoting maintenance of health behaviours and help in the development of an integrated theory of behaviour change maintenance.
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            Design and analysis of pilot studies: recommendations for good practice.

            Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.
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              Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors.

              Nearly 40% of mortality in the United States is linked to social and behavioral factors such as smoking, diet and sedentary lifestyle. Autonomous self-regulation of health-related behaviors is thus an important aspect of human behavior to assess. In 1997, the Behavior Change Consortium (BCC) was formed. Within the BCC, seven health behaviors, 18 theoretical models, five intervention settings and 26 mediating variables were studied across diverse populations. One of the measures included across settings and health behaviors was the Treatment Self-Regulation Questionnaire (TSRQ). The purpose of the present study was to examine the validity of the TSRQ across settings and health behaviors (tobacco, diet and exercise). The TSRQ is composed of subscales assessing different forms of motivation: amotivation, external, introjection, identification and integration. Data were obtained from four different sites and a total of 2731 participants completed the TSRQ. Invariance analyses support the validity of the TSRQ across all four sites and all three health behaviors. Overall, the internal consistency of each subscale was acceptable (most alpha values >0.73). The present study provides further evidence of the validity of the TSRQ and its usefulness as an assessment tool across various settings and for different health behaviors.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                17 October 2018
                : 8
                : 10
                : e022663
                Affiliations
                [1 ] departmentHealth Psychology & Behavioural Medicine Research Group, School of Psychology , Curtin University , Perth, Western Australia, Australia
                [2 ] departmentSchool of Physiotherapy and Exercise Science , Curtin University , Perth, Western Australia, Australia
                [3 ] departmentSchool of Public Health , Curtin University , Perth, Western Australia, Australia
                [4 ] departmentFaculty of Health Sciences and Sport , University of Stirling , Stirling, UK
                [5 ] departmentSocial and Public Health Sciences Unit , University of Glasgow , Glasgow, UK
                [6 ] departmentPriority Research Centre in Physical Activity and Nutrition , School of Education, University of Newcastle , Callaghan, New South Wales, Australia
                [7 ] departmentExercise Medicine Research Institute , Curtin University , Perth, Western Australia, Australia
                [8 ] departmentInstitute of Health and Well-being , University of Glasgow , Glasgow, UK
                [9 ] departmentMovement Physiology Laboratory , School of Physiology, University of Witwatersrand , Witwatersrand, South Africa
                [10 ] School of Occupational Therapy & Social Work, Curtin University , Perth, Western Australia, Australia
                Author notes
                [Correspondence to ] Dr Eleanor Quested; eleanor.quested@ 123456curtin.edu.au
                Author information
                http://orcid.org/0000-0001-8955-8809
                http://orcid.org/0000-0003-0255-1263
                http://orcid.org/0000-0002-7937-1570
                http://orcid.org/0000-0001-7122-3795
                Article
                bmjopen-2018-022663
                10.1136/bmjopen-2018-022663
                6196804
                30337315
                47e21363-c32a-41a7-8fbd-e3cb4817f0cb
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 22 March 2018
                : 28 June 2018
                : 21 August 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000960, Healthway;
                Categories
                Public Health
                Protocol
                1506
                1724
                Custom metadata
                unlocked

                Medicine
                public health,protocols,physical activity,obesity,intervention,men’s health
                Medicine
                public health, protocols, physical activity, obesity, intervention, men’s health

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