Effectiveness of randomized controlled trial of a mobile app to promote healthy lifestyle in obese and overweight patients.

Background. Health advice is useful for establishing behavioural changes, but such changes tend not to last. It would therefore be good to identify mechanisms for reinforcing advice and one option is the use of information and communication technologies. Given the limited evidence on the effectiveness of such technologies, we decided to conduct a clinical trial to assess the efficacy of a mobile application (app) for supporting the provision health advice for weight loss. Methods. A randomized clinical trial with 110 obese and overweight patients from the Basque public health care network (Araba). Patients were randomly allocated to the control (health advice) or intervention (health advice + app) groups. Primary (weight) and secondary (blood cholesterol level, blood pressure, haemoglobin A1c (HbA1c) and adherence to dietary and exercise recommendations) outcome variables were assessed at 1, 3 and 6 months after the end of the intervention. Results. There were no significant differences in weight (0.357 kg; P = 0.7), blood cholesterol (2.6 mg/dl; P = 0.617), blood pressure (2.3 mmHg; P = 0.369) or adherence to recommendations on diet (84.6% in control and 92.9% the intervention group, P = 0.413) or physical activity (56% in controls and 75% the intervention group, P = 0.145). On the other hand, there were significant differences in HbA1c in favour of the control group (-0.095%; %; P = 0.046). Discussion. The use of AKTIDIET (R) to support health advice for weight loss cannot be recommended. More high quality studies are needed, and patients should be involved in the design of apps to increase their efficacy and usability.