The Australian Department of Health (DoH) is considering funding a new intervention to reduce obesity in middle-aged Australian men aged 40-55. To evaluate the effectiveness of the new intervention, called 'Getting into shape', a randomised control trial (RCT) will be conducted. Getting into shape has been designed to reduce the risks of obesity-related diseases and additionally improve participants' social and psychological aspects of life. The intervention consists of eight weekly gym sessions given at a local gym to the participant. The gym sessions will use a local qualified personal trainer and will run for an hour long. In each of the eight gym sessions, the participant will undergo a tailored exercise regime designed at the time of the session by the personal trainer. At the end of the session the personal trainer will give the participant a booklet with the personalised exercise regime so the participant can use this information to workout in his own time if he chooses to do so. The trial will recruit Australian males ages 40-55 who are obese. Participants in the trial will be randomised to the intervention group where they receive the above Getting into shape intervention, or into the control group. Participants in the trial will be followed up for an additional ten months. The trial is due to begin in January 2023. The DoH wants to know whether Getting into shape represents value for money. You are part of a research team who has been asked to design a protocol for an economic evaluation alongside the clinical trial for Getting into shape. Your role in the team will be to answer the following questions:

Question 1 Justify why you believe an economic evaluation is needed and what control group you think is best to help inform the economic evaluation. 2

Question 2 Form a well-defined study question to help guide your economic evaluation. Make sure you include all the elements of a good study question, including how health outcomes will be measured. Include a comment on whether you think the time horizon of the RCT is appropriate.

Question 3 What type of economic evaluation do you think will be most appropriate for answering your study question? Justify the use of your chosen method and explain its strengths over other types of economic evaluations. NB: Don't forget to include justification based on your chosen health outcomes

Question 4 Identify the resources you will collect under the cost categories from Neuman et al (2017) pages 205-212, 217 (section 8.2 [not including section 8.2.4] and section 8.3).

Question 5 Outline the information and data sources that you would use for collecting the resources and cost information for your economic evaluation (focus on the measurement task of costing here).

Question 6 Explain how you will value each of your resource inputs in your economic evaluation.

Question 7 Explain and justify how you will collect and value the health outcomes you have chosen for your economic evaluation.