Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: The Fit2Quit study

Background: Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design: A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Mori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion: The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: the electronic games to aid motivation to exercise (eGAME) study

BACKGROUND: Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children.

METHODS/DESIGN: Three hundred and thirty participants aged 10-14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention).

DISCUSSION: An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial.

Migration intermediaries and codes of conduct: temporary migrant workers in Australian horticulture

Over recent decades, developments in network governance have seen governments around the world cede considerable authority and responsibility to commercial migration intermediaries for recruiting and managing temporary migrant labour. Correspondingly, a by-product of network governance has been the emergence of soft employment regulation in which voluntary codes of conduct supplement hard (enforceable) legal employment standards. This paper explores these developments in the context of temporary migrant workers employed in Australian horticulture. First the paper analyses the growing use of temporary migrant labour in this industry. It then describes how different types of intermediaries interact with this workforce. The paper then outlines both hard and soft employment regulations, and contrasts them with actual employment conditions, questioning how a network governance approach has affected this vulnerable workforce. The paper concludes that changes in network governance of migration and employment relations have emasculated formal legal regulation, leaving market forces to operate without effective or ethical constraints at the expense of the public good.