BACKGROUND: Connected health devices and applications (referred to hereafter as "SDApps" - Smart devices and applications) are being portrayed as a new way for prevention, with the promise of accessibility, effectiveness and personalization. Many effectiveness evaluations (experimental designs) with strong internal validity exist. While effectiveness does appear to vary, the mechanisms used by these devices have not yet been thoroughly investigated. This article seeks to unpack this black box, and describes the process of elaboration of an intervention theory for healthy eating and physical activity SDApps. It includes a set of requirements relative to their impact on social health inequalities. METHODS: To build this theory, we drew on theory-driven approaches and in particular on the theory of change (ToC) method. To this end, we developed a cumulative and iterative process combining scientific data from the literature with knowledge from experts (researchers and practitioners) and from patients or users. It was a 3-step process, as follows: 1 - identifying the evidence base; 2 - developing the theory through design intervention and creating realistic expectations, including in our case specific work on social health inequalities (SHIs); 3 - modeling process and outcome. RESULTS: We produced an evidence-based theory according to the ToC model, based on scientific evidence and knowledge from experts and users. It sets out a causal pathway leveraging 11 key mechanisms - theoretical domains - with which 50 behavior change techniques can be used towards 3 ultimate goals: Capacity, Opportunity, Motivation - Behavior (COM-B). Furthermore, the theory specifically integrates requirements relative to the impact on SHIs. CONCLUSIONS: This theory is an aid to SDAapp design and evaluation and it can be used to consider the question of the possible impact of SDApps on the increase in inequalities. Firstly, it enables developers to adopt a more overarching and thorough approach to supporting behavior change, and secondly it encourages comprehensive and contributive evaluations of existing SDApps. Lastly, it allows health inequalities to be fully considered.Read less <