Amendment to RFA-HD-04-020: Prevention and Treatment of Childhood Obesity in Primary Care Settings

Notice Number: NOT-HD-04-008

Key Dates
Release Date: September 8, 2004

Issued by
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)

The purpose of this Notice is to clarify several requirements for applications responding to RFA-HD-04-020, Prevention and Treatment of Childhood Obesity in Primary Care Settings: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-020.html.

The following information clarifies and expands on language in the RFA regarding the length of time required for interventions and follow-up of those interventions, specific to the grant mechanism to be used.

Two sentences currently in the RFA under RESEARCH OBJECTIVES/Scope are to be replaced with the text shown below.

Current text:

For exploratory/developmental studies, the intervention must be carried out for a minimum of 12 weeks, with a minimum follow-up of one year.

Replace with:

For exploratory/developmental studies [R21's], the intervention must be carried out for a minimum of 12 weeks; measurements must be made at the end of the intervention period and a minimum of six months post-randomization. Outcome measurements at 12 months post-randomization are encouraged, if feasible.

Current Text:

Full-scale trials supported by the R01 mechanism must include an intervention of at least 12 weeks and follow-up of at least two years and the primary outcome must be change in BMI (or BMI SD) and/or body composition.

Replace with:

Full-scale trials supported by the R01 mechanism must include an intervention of at least 12 weeks duration. The primary outcome must be a measure of obesity appropriate for children, such as comparison of change in BMI between randomized groups, change in BMI percentile or BMI SD-score or z-score (SD units), and/or measures of body composition. For proposed interventions that would be incorporated into ongoing medical practice, longer intervention periods are encouraged. Regardless of the duration of intervention, outcomes at two years post-randomization should be assessed.

Inquiries

For further information, contact:

Gilman Grave, M.D.
Chief, Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B11, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5593
FAX: (301) 480-9791
Email: graveg@mail.nih.gov


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