This special issue showcases how investigators working in different areas of health behavior change are utilizing early phase studies to advance intervention development. Through the publication of design or protocol papers for currently funded Science of Behavior Change (SOBC) network projects, the special issue illustrates how investigative teams are implementing the experimental medicine approach to advance our understanding of the mechanisms of action that underlie behavior change interventions and, in turn, develop an evidence base that can inform future intervention design. Given that a goal of the experimental medicine approach is the accumulation of an evidence base regarding the links between intervention strategies and putative mechanisms of action, it is critical that this evidence base is readily accessible to investigators and practitioners. Therefore, each of the included articles describes how it is implementing the open-science approach within its study protocol to ensure rigor and reproducibility. Each article provides information about how to register an early phase experiment before study conduct and how to publicly deposit the data, metadata, and publications. The special issue includes 10 design and protocol articles and 2 commentaries on a diverse array of scientific areas and approaches to test mechanisms of action for health behavior change interventions. By disseminating how the National Institutes of Health SOBC Initiative has supported the conduct of early phase intervention studies implementing the experimental medicine and open science approaches, the special issue provides a substantive roadmap to other scientists for how to adopt these approaches.
Bibliographical noteFunding Information:
This study was supported by the National Institutes of Health (NIH) Science of Behavior Change Common Fund Program through an award administered by the National Institute on Aging (U24AG052175). Karina W. Davidson is a member of the United States Preventive Services Task Force (USPSTF). This article does not represent the views and policies of the USPSTF.
To highlight the important role that early phase intervention studies play in the development of behavioral interventions, the Science of Behavior Change (SOBC), funded by the National Institutes of Health, launched an initiative focused exclusively on funding early phase mechanistic studies for health behavior change research programs. This initiative was designed to not only emphasize the importance of conducting studies prior to proceeding with a test of the efficacy of a behavioral intervention in a randomized controlled trial, but also to prompt investigators to engage with the theoretical and methodological challenges that underlie rigorous early phase research. In particular, this initiative prioritized the investigation of the mechanisms of action that are hypothesized to underlie a health behavior intervention’s effectiveness. To date, even when an initial intervention study returns some signal of behavior change efficacy, it is unknown if the mechanism of action was engaged as hypothesized and, in turn, was causally responsible for the resulting behavior change. Without this crucial scientific insight, small changes in the behavior change intervention across intervention development studies may cause the intervention to stop working without information about why. Moreover, even in the absence of these modifications, investigators may find that they are working with a set of intervention strategies that insufficiently—and perhaps inefficiently— engage the mechanism of action. To address this issue, the SOBC consortium requested that studies use the experimental method or add to an ongoing study that utilizes this approach and focus on generating evidence that links the proposed behavior change intervention to measured changes in the hypothesized mechanism of action.
- Early phase study design
- Experimental method
- Mechanisms of action
- Open science
- Science of behavior change