CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Participants were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favour of the IT-based arm. The intervention, ManUp, was informed by Social Cognitive and Self Regulation Theories and was specifically designed to target males. Educational materials were provided and self-monitoring of physical activity and nutrition behaviours was promoted. Intervention content was the same in both intervention arms, only the delivery mode differed, and content could be accessed throughout the 9-month study period. ' 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Participants were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favour of the fully automated IT-based arm. ' 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Participants, recruited offline (e.g. newspaper adds)' '. were measured using online surveys at baseline, 3 months and 9 months. ' This study was not blinded, given the differences between groups (IT vs Print) there was no way of blinding in what groups participants were. Because it is so obvious there is no need in mentioning this in the abstract 1b-iv) RESULTS section in abstract must contain use data A total of 301 participants completed baseline assessments, 205 in the IT-based arm and 96 in the print-based arm. A total of 124 participants completed all three assessments. ' 'The average number of logins to the IT-platform at 3 and 9 months was 6.99 (SE = 0.86) and 9.22 (SE = 1.47), respectively. The average number of self-monitoring entries at 3 and 9 months was 16.69 (SE = 2.38) and 22.51 (SE = 3.79), respectively. ' 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Not applicable for this study: outcomes did change! INTRODUCTION 2a-i) Problem and the type of system/solution Approximately 48% of males are not sufficiently physically active, and the majority of males do not meet the recommended intake levels of fruit (54%), vegetables (85%), consumption of low-fat dairy (63%) and consumption of foods containing high levels of saturated fat and sugar (70%). ' 'Web-basedand/or mobile phone-based interventions (IT-based) provide a delivery method that can be accessed by a large number of individuals. ITbased interventions have been used to effectively change physical activity and healthy eating behaviours and are viewed positively by males as an intervention delivery mode [9-12]. ' 2a-ii) Scientific background, rationale: What is known about the (type of) system Delivery of IT-based interventions using a combination of website and mobile devices may be an effective way to increase participant engagement with the intervention and promote greater behaviour change. Despite the potential of IT-based interventions to change physical activity and dietary behaviours, there have been few IT-based interventions that have been specifically developed for and targeted towards males [9, 20]. ' METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio The purpose of this study is to examine the effectiveness of a 9-month weband mobile phone-based intervention (IT-based) intervention to improve the physical activity, dietary behaviours and health literacy in middle-aged males compared to a print-based intervention [21]. ' 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Not applicable 3b-i) Bug fixes, Downtimes, Content Changes Not applicable 4a) CONSORT: Eligibility criteria for participants Males aged 35 to 54 years old who; (1) owned a mobile telephone, (2) had access to the internet, (3) did not have a mobility impairment, (4) resided in the cities of Gladstone or Rockhampton (Queensland, Australia), and (5) were classified as low risk to increase physical activity were eligible to participate in the study. ' 4a-i) Computer / Internet literacy It was not an implicit eligibility criterion (the website was purposefully designed to be very easy and simple to use), as it is likely that most participants would have had some form of Internet literacy, as Internet access was an eligiblity criteria, and all measures were web-based. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: To recruit participants, advertisements via local newspapers, trading magazines, face-to-face information sessions with local businesses, and distribution of leaflets and posters to local businesses, medical clinics, and offices of allied health professionals were used. ' 'Given participants completed the assessment of outcome measures via online survey. ' 4a-iii) Information giving during recruitment