Notice of Intent to Publish a Funding Opportunity Announcement for Science of Behavior Change: Assay Development and Validation for Self-Regulation Targets (UH2/UH3)

Notice Number:

NOT-RM-15-003

Key Dates

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

Related Announcements

NOT-RM-15-004, NOT-RM-15-005, NOT-RM-15-006

Issued by

National Institutes of Health (NIH)

Office of Strategic Coordination (Common Fund)

Purpose

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 to support a collaborative research infrastructure involving an interdisciplinary team of basic and clinical scientists to develop the foundation for an experimental medicine approach to behavior change. Research supported by this FOA is meant to support activities focused on behavior change targets in the domain of self-regulation. The output of these UH2/UH3 Target Validation Projects, to be facilitated by a Resource and Coordinating Center (RCC) (see NOT-RM-15-006), will be a toolkit of validated and documented assays of specific targets in the domain of self-regulation, and experimental manipulations/interventions that engage those targets.

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 to be supported 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 of, and 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 2015 with an expected application due date in the spring of 2015.

This FOA will utilize the UH2/UH3 Phased 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.

This UH2/UH3 Cooperative Agreement FOA, which is focused on the domain of self-regulation, will solicit applications to support a collaborative research infrastructure involving an interdisciplinary team of basic and clinical scientists to develop the foundation for an experimental medicine approach to behavior change. Research supported by this FOA is meant to focus on behavior change targets in the domain of self-regulation, through four main target validation steps:

1. Identify a set of two or more putative targets that are implicated in medical regimen adherence and at least one other health behavior;

2. Leverage existing or develop new experimental or intervention approaches to engage identified targets;

3. Identify or develop appropriate assays (measures) to permit verification of target engagement; and

4. Test the degree to which engaging identified targets produces a desired change in medical regimen adherence and at least one other health behavior. While testing target engagement in specific clinical samples is permitted, the targets identified and the behavior change outcomes measured should be selected based on their hypothesized relevance to at least two clinical endpoints or disease conditions.

For the purposes of this initiative, self-regulation refers to the process of managing emotional, motivational and cognitive resources to align mental states and behavior with our goals. Self-regulation is hypothesized to be a causal mechanism or crucial intermediate phenotype in the promotion of health and/or development of disease.

This Notice encourages investigators with expertise and insights in the following areas to begin to consider applying for this new FOA. The UH2/UH3 research teams will include both basic and clinical scientists. Teams should include expertise in research on self-regulation, as defined in this FOA, across multiple levels of analysis (e.g., neurobiological, psychological, behavioral, social). Teams must also include expertise in behavior change research relevant to one or more health behaviors, including medical regimen adherence. These scientists will collaborate with NIH staff and with the other UH2/UH3 teams to develop comprehensive ontologies for the target domain, and permit further cross-validation of assays. Substantial expertise in measurement development and tests of target engagement at multiple levels of analysis is required as well as appropriate expertise in clinical and behavior change fields. Teams can include scientists from a variety of disciplines, which may include, but are not limited to, psychology, psychometrics, cognitive and affective neuroscience, social neuroscience, behavior and molecular genetics, computational modeling, psychoneuroimmunology, human development, psychiatry, medicine, economics, and sociology. Collaborative investigations combining expertise in the described areas are encouraged and these investigators should begin considering responding to the forthcoming FOA.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Lis Nielsen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: nielsenli@nia.nih.gov

Christine M. Hunter, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: ch514c@nih.gov

Lisa Onken, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2235
Email: lonken@nida.nih.gov