Introduction:
Social-Local-Mobile (So-Lo-Mo) is an innovative intervention based on mobile technologies: it has the capacity to trigger behavioural changes. In this sense, the So-Lo-Mo App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. The purpose of this study is to analyse the efficacy of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care. Secondary study objectives are: (i) to analyse safety of pharmacological therapy; (ii) to analyse subjects’ motivation to give up smoking; (iii) to analyse subjects’ health-related quality of life; (iv) to monitor physical activity; and (v) to monitor healthy lifestyle habits.

Methods:
So-Lo-Mo study is a 12-months randomized open-label parallel-group trial performance at the Virgen del Rocio University Hospital premises. Efficacy was considered as the abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urine cotinine tests; safety was measured as the number of adverse events related with pharmacological therapies under consideration (either bupropion or varenicline); subjects’ motivation was measured through the Richmond test; health-related quality of life was measured through the EuroQoL-5D-5L questionnaire; physical activity was measured through the International Physical Activity Questionnaire (IPAQ-27); and lifestyle habits was measured through the subjects’ weight evolution during the follow-up period.

Results:
So far, data gathered from 59 subjects (30 women, 28 controls) has been analysed at 6 months form baseline, yielding the following results: (i) Efficacy: success rate were 53.6% and 71% for control and intervention groups respectively (p = 0.168). (ii) Safety: 12 adverse events were reported for the bupropion therapy (n = 24) while 30 adverse events were reported for the varenicline therapy (n = 35). (iii) Motivation: Richmond scores were 9.36 ± 0.83 and 9.50 ± 0.63 (p = 0.465) for control and intervention group respectively. (iv) Health-related quality of life: the average evolution on the Visual Analogic Scale (VAS) score was 6.87 ± 11.31 (p = 0.007) and 7.69 ± 16.20 (p = 0.023) for control and intervention groups respectively. (v) Physical activity: the evolution of metabolic equivalent (MET) minutes per week was 1120.42 ± 6113.12 and -10.36 ± 4188.47 (p = 0.436) for control and intervention groups respectively. (vi) Lifestyle habits: subjects’ weight evolution in kilograms was 3.51 ± 2.90 and 2.93 ± 5.77 (p = 0.202) for control and intervention groups respectively.

Conclusions:
(i) Efficacy: the So-Lo-Mo intervention provides a consistent improvement on the efficacy compared to controls. (ii) Safety: the number and type of the reported adverse events related to the pharmacological treatment is in keeping to their expected incidence as reported by the European Medicines Agency. (iii) Motivation: a slight bias on the subjects’ motivation has been reported, showing lower motivation score in controls compared to intervention group. (iv) Health-related quality of life: Statistically significant improvements in the VAS health score were found for both groups. Furthermore, a greater average improvement has been reported for intervention subjects compared to controls, which suggest that the intervention has an added value. (v) Physical activity: physical activity evolution has been reported higher for controls compared to intervention subjects. This finding should be taken with care, since the variability reported for the increments in the IPAQ27 score is very high and, therefore, more observations are needed before drawing a conclusion from this analysis. (vi) Lifestyle habits: weight increment in control group was reported to be higher when compared to intervention group. This finding, in combination with the efficacy, could support the preliminary conclusion that the So-Lo-Mo intervention improves the efficacy of the smoking cessation process while helps to control weight increments associated to the nicotine abstinence. Preliminary analyses show a very promising trend in achieving the main objective of this study. However, stronger statistical significance is needed to endorse this statement.