Effectiveness of a website and mobile phone based physical activity and nutrition intervention for middle-aged males: Trial protocol and baseline findings of the ManUp Study

Reducing disease and the prevalence of avoidable risk factors associated with poor health in males is attracting considerable attention within the public health agenda. This is evidenced in both developed and developing countries by the advancement of several recent policy initiatives and other strategies dedicated to improving the health of males [1, 2]. These initiatives are based on a recognition that, compared to females, males experience higher rates of overall premature mortality, cardiovascular disease related mortality, suicide, diabetes, and obesity [2, 3]. These health outcomes are linked to males’ high levels of behavioural risk factors including high levels of physical inactivity, poor nutrition behaviours, high risk drinking and smoking [2, 3].

Improving the physical activity levels of males is vital to improving their health, as physical inactivity is one of the most significant risk factors for the leading causes of preventable death and burden of disease in Australian males [2]. Physical inactivity is characterized by high levels of sedentary behaviours, such as sitting, and/or low levels of participation in moderate-to-vigorous intensity physical activity, such as walking. Australian surveillance data indicate that males report more than 3 hours of occupational sitting, and 5.5 hours of total sitting per day [4, 5]. Although approximately 53% of males report engaging in sufficient levels of physical activity for health benefit, the proportion of males engaging in sufficient physical activity has not increased in recent years [6].

Improving nutrition behaviours is similarly important for improving male health, as poor nutrition behaviours also rank highly among risk factors for the leading causes of preventable death and disease in Australian males [2]. Poor nutrition behaviours are characterized by low consumption of fruits, fibre, vegetables, and fish, and high consumption of saturated fat and alcohol. Fruit and vegetable consumption is low in males, with fewer than 6.5% of males consuming recommended daily serves of fruit and vegetables [7, 8] and 15% reporting that they consumed alcohol at high-risk levels [9]. Furthermore, approximately half of adult males consume full-cream milk on a usual basis and takeaway food at least once per week, which is indicative of high saturated fat intake [10].

Despite ample evidence of demonstrated need for improvement in health and related behavioural risk factors, males are frequently underrepresented in health-promotion and chronic disease prevention intervention efforts [11, 12], and report that the interventions that are frequently adopted by females do not appeal to them [13]. Thus, there is a need to develop interventions that specifically target physical activity and nutrition behaviours of males in a way that is tailored to their preferences. The format of the messages, presentation of information delivered, mode of information delivery, and methods to engage participants are key intervention strategies than can be tailored to males. Website-delivered interventions can be tailored to specific user preferences and needs, are viewed favourably by males, and can positively alter levels of overweight, physical activity, and selected dietary behaviours [12, 14, 15]. The accessibility of such website-delivered interventions may also be more appealing to males who cannot attend face-to-face interventions due to clashes with work, family responsibilities, and other schedules [16]. Additionally the capacity of website-delivered interventions to be accessed by large numbers of males in need of health behaviour change is beneficial. The provision of educational materials, goal setting strategies, and tools to promote self-monitoring have been shown to be effective methods to change physical activity and nutrition behaviours [12, 17‐19]. Our formative research on these issues demonstrated that males are somewhat knowledgeable on the levels of physical activity and healthy eating required to promote health, but that they also want information on these topics provided in a clear and simple way to avoid confusion associated with multiple media campaigns and messages [20, 21]. Tailoring health promotion messages in this way is important as the materials not only need to provide information in an ‘easily digestible’ format for males, but must also empower males to use this information to positively change their behaviours [22]. This process of applying knowledge to change behaviour, or health literacy, plays an important role in health promotion and is relatively low in many populations [22]. Males also acknowledge the importance of self-monitoring behaviours, but want this to be completed in a time-efficient and user-friendly manner [21]. As such, website-delivered interventions that incorporate these characteristics and features may be useful to positively change physical activity and nutrition behaviours.

Self-monitoring of health behaviour is a common behaviour change strategy implemented in many health promotion interventions [23], and is positively associated with greater behaviour change across a range of health behaviours [17, 18]. Mobile (cell) phones that store data locally and/or connect to the internet offer participants a modern and technologically sophisticated way to self-monitor behaviour, may offer greater convenience when compared to more traditional self-monitoring methods, and allow transfer of data to a website that contains other intervention materials and components [21]. However, the use of websites and/or mobile phones, to self-monitor physical activity or nutrition behaviours, specifically targeted at males, remains largely untested. This manuscript describes the rationale, design, and baseline findings from the ManUp Study, which aims to examine the effectiveness of an information technology (IT) based intervention that uses both websites and mobile phones to improve the physical activity and nutrition behaviour and literacy in middle-aged males.

The ManUp Study design is a two-arm randomised controlled trial with assessment points at baseline, three, and nine months. One intervention arm used an IT-based approach (website and mobile phones) to deliver physical activity and healthy eating promotion materials, and to promote self-monitoring of these behaviours. The second intervention arm used a more conventional print-based approach to deliver the same health promotion materials. Both intervention arms provided participants with the same materials and ability to self-monitor their behaviours, although the IT-based intervention additionally provided participants with automated feedback on their progress towards completing physical activity and nutrition goals, and the ability to interact with other participants on the website platform as a social support mechanism (Table 1). The IT-based intervention allowed participants to self-monitor physical activity and nutrition behaviours using either the website or mobile phone platform. A print-based comparison group was selected rather than a wait-list control group as it has been demonstrated that print-based interventions are effective [24, 25]. Participants provided informed consent prior to participation and the study was approved by Central Queensland University, and the University of Western Sydney’s Human Research Ethics Committees. The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000081910).

This paper describes the intervention design, study protocol and baseline characteristics of a sample of middle aged males who took part in the ManUp Study. This study was designed in an attempt to address some of the key issues associated with conducting research in the middle-aged male population. These issues include specifically designing the intervention with the needs and preferences of males in mind to increase intervention appeal, and focusing on behavioural risk factors most relevant to men. The study protocol will allow the efficacy of an IT-based delivery of the intervention to be compared to a print-based delivery mode. If the IT-based delivery mode is found to be efficacious, it will provide the foundation for similar interventions that take advantage of the increased reach of IT-based interventions to be developed for this population group. Within the IT-based intervention arm, it will be possible to determine the presence of any relationships between engagement with the platform and change in outcomes. This will provide much needed information in this area as reviews of such interventions have identified that a low proportion of males engage in these interventions [12, 19]. The ManUp Study will also collect information on the components of the IT-based intervention that are utilized, and this information can be used to refine the strategies adopted in future IT-based interventions by focusing attention on those that participants use most frequently.

Males are frequently reported to have high levels of anthropometric and behavioural risk factors of poor health, and this is the underlying rationale for the current study [2, 3, 8]. Baseline characteristics of the ManUp Study participants indicate, that like many males, they are generally overweight or obese, have poor nutrition behaviours and have a low level of total physical activity. Over 85% and 80% of participants are classified as overweight or obese when using self-reported and measured BMI respectively; this is higher than levels of self-reported overweight or obesity in Queensland and Australian adult males [3, 8, 51]. The proportion of participants who self-reported physical activity at a level sufficient to meet guidelines in print- and IT-based intervention arms (42.7% and 38.0%) is lower than that observed in population-based samples covering similar geographical areas (52.8%) [6]. Furthermore, in comparison to other available data [52], the current sample spends more time in sedentary behaviour and less time in light intensity physical activity. The average nutrition behaviours of the study sample were below that recommended for Australian adults, and the proportion of the sample who achieved the minimum guidelines for fruit and vegetables was lower than that reported for other Australian males [8].

Levels of physical activity literacy in the current sample were lower than those previously reported in Australian males [53], particularly for awareness that accumulating physical activity in 10-minute blocks can still provide health benefits. Over a decade has passed and significant financial investment has been directed toward the promotion of physical activity in Australia and the levels of physical activity literacy in the current sample are lower than those reported in 1999 [53]. While this is concerning from a health promotion perspective, it also provides a unique opportunity to intervene and attempt to address the issue in the current sample of participants to inform subsequent promotion efforts. In contrast, levels of nutrition literacy were relatively high with the median score of both intervention groups close to the maximum level and comparable to levels reported in the sample the instrument was developed in [47]. This is a positive finding in the current study, and somewhat unexpected given that males in our formative study reported confusion around nutritional messages [20].

Subsequent phases of the ManUp Study will evaluate changes in physical activity, nutrition behaviours, and health literacy of those topics over the intervention period, and will compare the efficacy of the two intervention arms to change these outcomes.