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Unformatted text preview: FSN 420 paper evaluation form clinical studies updated Fall 2011 Kim Chin Study (author, date): Barbara V. Howard, Linda Van Horn, Judith Hsia, etc., 2006 Research Question (What is it? Clearly stated? Is there a hypothesis?): The hypothesis was that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. In this WHI Dietary Modification Trial, the primary research question was whether behavioral intervention intended to produce a dietary pattern low in total fat, along with increased intakes of vegetables, fruits, and grains would decrease the incidence of breast and colorectal cancer in postmenopausal women. And whether such a dietary intervention which didn’t focus on the intake of specific fats would also reduce the risk of CVD? Design (Specify: Controlled? Randomized? Cross-over? Blind? Double blind? Appropriate lead-in and wash-out periods if appropriate? And briefly describe what was done plus a graphical representation): 48,835 women between the ages of 50 and 79 years were enrolled between 1993 and 1998 at 40 US clinical centers and were randomly assigned to an intervention group: low fat diet (n=19541, 40%) or a usual-diet comparison group (n=29294) using a randomized permuted block algorithm with blocks of size 5, 10, or 15 stratified by clinical center site and age group. It was somewhat blind, because the physicians didn’t know which group they were part of when measuring CHD, but the subjects weren’t blinded because eating fruits and vegetables was could have been obviously seen as eating a lower-fat diet. It was a controlled study. They were supposed to be weight stable and not have a reduced energy intake. Then they were to get analyses of CHD in a mean of an 8.1 year period.--- ---- ----------- ----------- ---- ---- |-------------------------Present-------------------------------| |----------Future----------| Subjects ((What are inclusion and exclusion criteria? Were they appropriate? Were health, demographics, and other characteristics of subjects described? What was the target population, and were the subjects a representative sample of the relevant target population of interest? Was selection of study group(s) free from bias? What was sample size?): Eligibility criteria included being postmenopausal and consuming at baseline a diet with fat intake of 32% or more of total calories, as assessed by a food frequency questionnaire (FFQ). Major exclusions for WHI included prior breast or colorectal cancer, other cancers except nonmelanoma skin cancer in the last 10 years, medical conditions with predicted survival less FSN 420 paper evaluation form clinical studies updated Fall 2011 than 3 years, and adherence concerns such as alcoholism. Also, trial-specific exclusions included type 1 diabetes and frequent consumption of meals prepared away from home. Yes, this was appropriate for this specific study with the risk of cardiovascular disease. 48,835 women appropriate for this specific study with the risk of cardiovascular disease....
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- Fall '11
- Nutrition, comparison group, CHD, paper evaluation form