Effectivity of a mHealth intervention for individuals with obesity: a study protocol for a controlled intervention study

Background Obesity is considered an epidemic problem with an increasing number of individuals affected. The physical and psychological complaints associated with obesity point to the importance of implementing effective interventions. Innovative mHealth applications appear to be promising in helping provide a continuous and flexible support during the intervention. Since research on mHealth interventions is still relatively sparse, the main goal of the current study is to assess the effectiveness of an mHealth obesity intervention in terms of weight reduction, health behaviours as well as health-related quality of life. In addition, the study aims to investigate various psychological explicit and implicit processes associated with physical activity behaviour. Methods The study includes quantitative and qualitative methods. Regarding the quantitative methods, the goal is to recruit up to 450 individuals at baseline in different obesity centres across Germany with some of these centres offering an mHealth intervention. All individuals who agree to take part in the mHealth intervention will be assigned to the intervention group, while all other individuals will be assigned to the control group. The mHealth obesity intervention consists of three stays at an obesity centre, with approximately six months between stays during which patients are supported by the digital platform CASPAR. The study includes three measurements with a baseline measurement and two follow-up measurements, one after six months and one after twelve months. To assess the effectiveness of the intervention, body weight, physical activity behaviour, eating behaviour as well as health related quality of life will be assessed. In addition, motivation, intentions, self-efficacy, enjoyment, and habit will be used to assess the psychological processes related with physical activity behaviour. A multivariate analysis of variance with repeated measurement and latent growth curve models will be used to compare the development of the variables within the two groups. In relation to the qualitative methods, interviews with individuals of the intervention group will be conducted to shed light on the applicability, acceptance, and usability of the mHealth intervention. Discussion This study may provide a valuable insight into the potential of mHealth obesity interventions and the psychological processes related to physical activity behaviour. Trial registration The trial has been registered with the German Register of Clinical Studies (DRKS) on June 30, 2021 under the registration number: DRKS00024836.