Frequently Asked Questions for RFA-HL-08-007: Targeted Approaches to Weight Control for Young Adults (U01)

Questions for September 2008:

Q: Do we have to submit a proposal for a Research Coordinating Unit (RCU)?
A: Yes. We would like to clarify that a Research Coordinating Unit (RCU) plan is required. (Applications not including a RCU plan will be considered non-responsive.)

Please submit 1 application but include two sets, each consisting of a descriptive plan and budget, one for the research project (<=25 page description) and one for the Research Coordinating Unit (<=5 page description). Include only 1 cover sheet and checklist.

Q: Do we submit a separate application for the RCU?
A: No. See above.

Q: Does the intervention have to be 24 months long or can it be shorter with a 24 month follow-up?
A: The intervention has to be 24 months! If you are proposing more than one active intervention arm, each participant in at least one arm must receive a full 24 months of intervention. In most of our weight loss/maintenance studies, we have observed that a longer period of intervention is needed to maintain weight control. For this reason, we require that there be a full 2 years of intervention.

Q: We are working with local high schools. Can we have participants who are 17 years old?
A: No. In order to responsive to the RFA, participants must be young adults aged 18-35.

Q: Is a formative phase required?
A: Yes. The formative phase (1-2 years) is an opportunity to refine and pilot test the proposed intervention. However, the formative phase could be shortened for applicants who already have sufficient formative information. If this is the case, then the formative phase information should be presented in the application to support and justify the proposed components of the Phase 2 study.

Q: I am interested in increasing physical activity. Can physical activity be my primary outcome?
A: No. In order to be responsive to this RFA, the primary outcome has to be change in weight or BMI. An increase in physical activity could be a secondary outcome.

Q: Do I need to submit the application via paper format?
A: YES. Please use the PHS 398 research grant application instructions and forms.

Last update: September 22, 2008