Adherence

Behavioral treatments for chronic diseases must undergo a structured, iterative pre-efficacy development process (ORBIT model) involving Phase I (Design) and Phase II (Preliminary Testing) to ensure clinical significance before large-scale efficacy trials.

If you are developing a health behavior intervention, do not skip to large-scale testing. Use the ORBIT model: Start with Phase I (Design) to define the problem and basic elements, then Phase Ib (Refine) to optimize components and delivery. Only move to Phase II (Preliminary Testing) when you have a fixed protocol that shows clinically significant change in a small sample. This iterative process ensures your final large-scale trial has a real chance of success.