Call for Pilot Project Proposals
The Boston Roybal Center for Active Lifestyle Interventions (RALI Boston), funded by the National Institute on Aging, is pleased to issue a call for pilot study proposals focused on behavioral interventions to promote healthy aging, especially those that enable middle-aged and older adults to adopt and/or maintain active and engaged lifestyles.The Center’s mission is to improve the health and well-being of at-risk, vulnerable populations (e.g., from minority or low income groups; those who are inactive, socially isolated, or have chronic conditions) and to identify the most effective mechanisms for adaptive behavior change. We are interested in multifaceted, holistic interventions engaging multiple systems (e.g., psychological, social, cultural, neural, nutritional, physical, biomedical, spiritual, cognitive, motivational) to promote active, engaged, and healthy lifestyles despite the challenges of aging and disability. All studies should be pilot clinical trials, to be registered on clinicaltrials.gov, that fit within the NIH Stage Model for Behavioral Interventions and the Science of Behavior Change approach. The scope of the project should allow for completion within a one-year timeframe.
We seek pilot proposals for innovative pilot projects that use behavioral approaches to increase and sustain active engagement. We are also interested in collaborative applications that leverage expertise and resources (e.g., functional assessment core) at the Boston Pepper Older Americans Independence Center . New proposals and ongoing projects that add a behavioral component to the study design will be considered. We encourage the use of measures from the Roybal Center Tool Box and Cores at the Boston Pepper Center. Investigators, including junior faculty and postdoctoral trainees, from the Center’s five collaborating institutions (Brandeis University, Boston College, Northeastern University, Boston University, Hebrew Senior Life/Harvard Medical School) are invited to apply. Those from other Boston-area institutions may apply if they are collaborating with or mentored by a member of the Roybal Center executive committee.
Applicants should submit:
- Project Proposal - (a.) cover page with project title, investigators' names and affiliations, and an abstract up to 350 words; (b.) a 3 to 4-page proposal, (c.) references, and (d.) protection of human subjects plans. The 3 to 4-page body of the proposal should include specific aims, background and significance, innovation, study design, a description of the intervention, proposed measures, sample and sample size justification, analytic plan, and potential for future publications, products and independent funding. Please use Arial size 11 font and 1/2 inch (.5) margins all around with single spacing. The project proposal should also acknowledge and fit within the NIA Stage Model.
- A biosketch on the newest NIH form (docx) [Download a sample of the biosketch (.docx)]. Include biosketches for all investigators as well as the name, highest degree, institution, address, phone number, and email address of each co-investigator in one pdf file for submission.
- A 1-year detailed budget on Form 4 (pdf) (maximum of $50,000 - $75,000 direct costs).
- Total 1-year budget and budget justification on Form 5 (pdf) signed by an institutional official.
List all investigators and their specific roles on the budget justification form, even if not drawing salary.
- A Planned Enrollment Form (PDF) detailing the planned enrollment counts for the proposed study.
- Protection of Human Subjects Plan. See the Guidelines for the Protection of Human Subjects Plan. Please include at the end of the Project Propsal for submission.
- Data And Safety Monitoring Plan (DSMP). Please include at the end of the Project Proposal for submission. See the NIA/BSR DSMP Template (docx) and DSMP Requirements Checklist (docx). Some clinical trials may require a Data and Safety Monitoring Board (DSMB), if so please refer to the Sample DSMB Charter (docx) . To determine if your proposed study requires a DSMB, please consult the DSMP Decision Tree (docx).
- Overview of NIA Roybal Centers
- All investigators will be required to complete the CITI Human Subjects Training and the Good Clinical Practice Training Course.
- Pilot data will be made available for resource sharing. For more details, see the NIA's resource sharing policies.
- Selected pilot projects must be registered on clinicaltrials.gov and all de-identified data must be submitted to the Roybal Center for data sharing.
- Those who are funded will have to complete the PHS Human Subject and Clinical Trials Information form.
- Stage Model for Behavioral Intervention Development
- NIA Guidance on Clinical Trials
- NIH Policy for Data and Safety Monitoring
- NIH Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
- Guidance on Reporting Adverse Events to the Institutional Review Boards for NIH-Supported Multicenter Clinical Trials
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
Please submit all application materials online by the deadline: January 17, 2020.We expect to select 2-3 of the most meritorious proposals by March 2, and to begin funding on June 1, 2020. Funding decisions will be based on the proposal’s relevance to the RALI Boston mission, ability to advance our knowledge of behavioral interventions and associated mechanisms to promote active engagement and healthy aging, and potential for future publications and independent funding. Pilot study investigators will be invited to meet periodically with other Center investigators and develop new collaborative relationships, harmonize their outcome measures (see RALI Toolbox measures on the website), share research findings and data sets, submit progress reports, and attend Roybal Center meetings.