A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population's specific needs. The online intervention "MyPlan 2.0" targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population.

Objective: The aim of this paper is to thoroughly describe "MyPlan 2.0" and the study protocol that will be used to test the effectiveness of this intervention to alter patients' levels of physical activity and sedentary behavior.

Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients' stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted.

Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019.

Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time.

International Registered Report Identifier (irrid): DERR1-10.2196/12413.