mHealth Coaching Towards Healthy Aging in Physical Activity and Nutrition Domain: Protocol and Baseline Assessment

The evolution of the mHealth era offers the possibility of behavioral interventions to promote changes in lifestyle habits with prevention relevance. These tools are considered digital therapeutics (DTx) and follow the MDR 745/2017 for testing, validation, and certification. In the frame of the ACTIVE3 project, we developed a platform composed of a mobile app, a wearable device, and a cloud backend to support healthy aging intervention in a population of 60–80-year-old subjects. This paper describes the clinical trial protocol and the baseline data of the recruited population. The explored parameters describe the effect of the DTx in the physical, nutritional (and metabolic), and cognitive domains, leveraging the Walking Group initiatives coordinated by ATS Brianza that are active in the Lecco area; in addition, system usability and acceptance were analyzed. The study started on 1 September 2024, and the analyzed baseline data are presented here. With respect to an expected population of 200 subjects, we received interest and consent to participate from 237 subjects: over-enrollment was allowed and all these subjects were accepted into the study. The characterization of the study population at the initial time of the trial was carried out, and the outcomes are presented here. The population is generally more active than Italian people of the same age. According to the outcome of the 6MWT, the population was divided into three groups: trained participants (42 subjects), active participants (142 subjects), and sedentary participants (58 subjects). The tests at month 12 were recently competed, and the final results will be available in winter 2025–2026.