Protocol for economic evaluation alongside the SHINE (Supporting Healthy Image, Nutrition and Exercise) cluster randomised controlled trial

Abstract

IntroductionLimited evidence exists on the cost-effectiveness of interventions to prevent obesity and promote healthy body image in adolescents. The SHINE (Supporting Healthy Image, Nutrition and Exercise) study is a cluster randomised control trial (cRCT) aiming to deliver universal education about healthy nutrition and physical activity to adolescents, as well as targeted advice to young people with body image concerns who are at risk of developing disordered eating behaviours. This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.Methods and analysisA public payer perspective will be adopted, with intervention costs collected prospectively. Within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will quantify the incremental costs and health gains of the intervention as compared with usual practice (ie, teacher-delivered curriculum). CEA will present results as cost per body mass index unit saved. CUA will present results as cost per quality-adjusted life year gained. A modelled CUA will extend the target population, time horizon and decision context to provide valuable information to policymakers on the potential for incremental cost offsets attributable to disease prevention arising from intervention. Intervention costs and effects will be extrapolated to the population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort’s lifetime. Modelled CUA results will be presented as health-adjusted life years saved and healthcare cost-savings of diseases averted. Incremental cost-effectiveness ratios will be calculated as the difference in costs between the intervention and comparator divided by the difference in benefit. Semi-structured interviews with key intervention stakeholders will explore the potential impact of scalability on cost-effectiveness. These data will be thematically analysed to inform sensitivity analysis of the base case economic evaluation, such that cost-effectiveness evidence is reflective of the potential for scalability.Ethics and disseminationEthics approval was obtained from the Deakin University Human Research Ethics Committee (#2017–269) and the Victorian Department of Education and Training (#2018_003630). Study findings will be disseminated through peer-reviewed academic papers and participating schools will receive annual reports over the 3 years of data collection.Trial registration numberACTRN 12618000330246; Pre-results.

A systematic review of economic evaluations of web‐based or telephone‐delivered interventions for preventing overweight and obesity and/or improving obesity‐related behaviors

“…Results demonstrate that the evidence for cost‐effectiveness is mixed and that the majority of economic evaluation studies published to date featured telehealth (rather than eHealth) delivery modes. This highlights the need for more research into effectiveness and cost‐effectiveness for obesity prevention interventions delivered using evolving and innovative delivery modes such as eHealth, 12,64 given the growing interest in the use of these technologies in the field 15,64–68 . Following recent world events, including COVID‐19, there is a need to embrace and best utilize technologies for remote delivery of both treatment and preventive health care 69 .…”

“…Although we found only one published economic evaluation of an obesity prevention intervention with a telehealth or eHealth component that targeted adolescents, 55 several studies are currently underway in child populations. For example, a protocol for the economic evaluation of the Supporting Healthy Image, Nutrition and Exercise (SHINE) intervention was recently published and includes an eHealth modality for intervention delivery to secondary school students 77 . An economic evaluation of an early childhood obesity prevention intervention using telehealth and mHealth modalities (Communicating Healthy Beginnings Advice by Telephone [CHAT]) is also currently underway 78 .…”

Exploring the economics of public health intervention scale-up: a case study of the Supporting Healthy Image, Nutrition and Exercise (SHINE) cluster randomised controlled trial

“…The intervention replaces the usual Health and Physical Education (HPE) classroom-based curriculum [ 20 ] for eight weeks and aims to improve body image, mental health, nutrition and physical activity and to help prevent the development or progression of overweight and obesity. The SHINE study incorporates a “within-trial” and modelled economic evaluation [ 21 ]. This means that the costs and consequences of the SHINE intervention have been collected exactly as they occurred within the controlled research environment.…”

“…This means that the costs and consequences of the SHINE intervention have been collected exactly as they occurred within the controlled research environment. This ‘within trial’ data will then inform a modelled evaluation that extrapolates the decision problem to a wider population and across a longer time horizon [ 21 ].…”

“…This will also provide health economists and trialists with a case study example of how qualitative research methods might complement more traditional quantitative data collection and analysis in health economic evaluation, to generate economic evidence potentially relevant to implementation and scale. Finally, the evidence generated will help to inform the extrapolation of potential intervention costs for the modelled economic evaluation of the SHINE intervention [ 21 ].…”