Notice of Intent to Publish a Funding Opportunity Announcement for NIH Science of Behavior Change Resource and Coordinating Center (U01)
Release Date: November 14, 2014
Estimated Publication Date of Announcement: January 2015
First Estimated Application Due Date: March 2015
Earliest Estimated Award Date: September 2015
Earliest Estimated Start Date: September 2015
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
The NIH Science of Behavior Change (SOBC) Common Fund Program intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for a U01 Cooperative Agreement to support the NIH Science of Behavior Change (SOBC) Resource and Coordinating Center (RCC), which will coordinate the activities of between five and nine UH2/UH3 Target Validation Projects focused on identifying and validating targets in the three specific behavioral domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes. The primary goal of the RCC will be to provide national leadership for the coordinated efforts of projects and initiatives of SOBC to validate assays for behavior change, and serve as the central resource for the organization of the meetings and other activities of the SOBC program, including the support of its Steering Committee and External Scientific Panel, and any SOBC steering committee subcommittees that are established.
The overall goal of the SOBC Program is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the tools required to implement such an approach. An experimental medicine approach involves identifying an intervention target, developing assays to permit verification of target engagement, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change. For the purposes of this announcement, putative intervention targets represent mechanisms or processes that are hypothesized to be malleable and to play a causal role producing behavior change. Each project in the SOBC Research Network to be coordinated by the RCC must address two or more behaviors, one of which must be adherence to medical regimens. Behavior change, as defined here, includes the initiation, cessation, modification, maintenance, and/or adherence to health behaviors (e.g., diet, exercise, abstinence from substance use, behavioral regimens, treatment regimens) that have broad health implications across a wide range of clinical endpoints. Work supported by the initial SOBC Program [http://commonfund.nih.gov/behaviorchange/index] identified three domains with promising behavior change targets: self-regulation, stress reactivity and stress resilience, and interpersonal and social processes.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in winter of 2015 with an expected application due date in the spring of 2015.
This FOA will utilize the U01 Cooperative Agreement activity code. Details of the planned FOA are provided below.
Research Initiative Details
Human behavior accounts for about 40 percent of the risk associated with preventable premature deaths in the United States. Substance use and abuse, physical inactivity, poor diet, poor sleep habits, and risk-taking in a variety of contexts are among the many behaviors known to play a role in adverse health conditions. Well-documented non-adherence to medical regimens serves as an exemplar of the challenges in initiating and sustaining healthful behavior change.
Promoting explicit testing of mechanisms in behavior change research is long overdue. In general, behavior change interventions have not been based on explicit tests of target engagement using well-validated assays. Instead, behavior change interventions tend to combine multiple components meant to engage a variety of targets, whether specified or not. Moreover, few intervention studies are designed to test whether the intervention actually engaged the (multiple) target(s) it was meant to engage, and whether engagement of the target(s) produced the desired behavior change. As a result, even successful intervention studies do not always inform behavior change research beyond the context in which they are tested. The work of the initial SOBC Program set the stage for a mechanisms-focused, experimental medicine approach as an alternative to the inefficient multi-component intervention, “black box” approach. This experimental medicine approach seeks to develop interventions that engage targets hypothesized to be putative mechanisms of change, and includes explicit tests of both target engagement and behavior change.
Between five and nine UH2/UH3 Target Validation Projects (see NOT-RM-15-003, NOT-RM-15-004, NOT-RM-15-005) will be facilitated by a Resource and Coordinating Center (RCC) solicited under a companion FOA (U01). The RCC will 1) Establish, curate, and maintain a publically available registry of validated assays and experimental methods for engaging and measuring specified behavior change targets; 2) Develop, adapt, and adopt technical guidelines and best practices for the validation of assays of behavior change targets that can be incorporated into behavior change trials to make them more informative; 3) Disseminate widely the SOBC registry of assays, interventions or manipulations that engage targets, best practices, guidelines, and data produced over the course of the program; 4) Conduct systematic reviews of the behavior change literature and specifically the medical adherence literature in order to identify additional potential targets for future validation or research; and 5) Help coordinate activities between multiple grantees working on a single target class and ensure that results produced will be suitable for the RCC’s first three objectives.
This Notice encourages investigators with expertise and insights in the following areas to begin to consider applying for this new FOA:
- Conducting systematic reviews and meta-analyses of existing clinical trial reports and archived data sets, and using these sources to generate testable hypotheses concerning potential putative intervention targets, differential response of individuals to treatment, and estimates of intervention efficacy and effectiveness;
- All aspects of behavior change research and NIH-approved Good Clinical Practices (see http://www.nhlbi.nih.gov/research/funding/research-support/crg/management/comply-gcp.htm for more information) as well as ethical issues related to clinical research;
- Facilitating cooperation between basic and clinical scientists and in behavioral intervention development;
- Helping to take research questions from hypothesis to implementation and the ability to document these processes;
- Study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and behavioral trial designs;
- Creativity and innovation in solving technical and project challenges, as well as coordinating efforts among disparate research communities; and
- The three target domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes.
Applicants for the Resource and Coordinating Center U01 are encouraged to include expertise across a range of scientific disciplines (e.g., basic and applied behavioral research), and health or disease conditions (e.g., adherence behaviors, other clinical endpoints). Applicants are also encouraged to include expertise in assay or measures development, and in the design of studies that allow for tests of causal mechanisms of behavior change.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Wendy Weber, ND, PhD, MPH
National Center for Complementary and Alternative Medicine (NCCAM)
Jonathan W. King, PhD
National Institute on Aging (NIA)