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fsn420.writteneval16 - FSN 420 paper evaluation form...

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FSN 420 paper evaluation form clinical studies updated Fall 2011 Kim Chin Study (author, date): Frank M. Sacks, 2001 Research Question (What is it? Clearly stated? Is there a hypothesis?): There are multiple questions in this study, including: “Does reducing the level of sodium from the average intake in the United States (approx. 150 mmol per day) to below the currently recommended upper limit of 100 mmol per day lower blood pressure more than reducing the sodium level only to the recommended limit?” They hypothesized that it would, on the basis of both the blood pressure levels in populations with an average consumption of less than 60 mmol of sodium per day and data from incompletely controlled or small clinical trials. Also, “does the DASH diet lower the blood pressure beyond the level achievable by simply reducing sodium intake? What is the combined effect of the DASH diet and reduced sodium intake?” 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): During a two-week-run in period, eligible persons at the high sodium control diet. Participants were then randomly assigned to follow one of the two diets according to a parallel-group design . They ate their assigned diet at each of the three sodium levels for 30 consecutive days in random order in a crossover design . They compared the effect on blood pressure of three levels of sodium intake in two diets among adults whose blood pressure exceeded 120/80 mm Hg, including those with stage 1 hypertension. The trial was conducted from September 1997 to November 1999. Each participant’s energy intake was adjusted to ensure that his or her weight remained constant throughout the study. Each of four clinical centers conducted the trial in four or five cohorts of participants. During the run-in period, blood pressure was measured with random-zero sphygmomanometers twice, then weekly during the first three weeks of each of the three 30-day intervention periods (wash-out periods) at five clinic visits during the last 9 days. Also a 24-hour urine collection was obtained during the screening period and during the last week of each intervention period. The analyses were structured according to a two-by-four design to compare the two diets (control and DASH) during the four periods (run-in period and 3 intervention periods). The primary outcome was systolic blood pressure at the end of each 30-day period of dietary intervention and the secondary outcome was diastolic blood pressure.
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