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(for at least one location)
Describes the nature of a clinical study. Types include:
Patients age 25 to 75 who are in the care of one of the primary care physicians at Mayo Clinic in Jacksonville, Florida or Montage Health in Monterey, California and have a recent HbA1c in the range of 7.5% to 13% will be prospectively identified and eligible for participation in this randomized, crossover clinical trial examining the effect of medically tailored meal delivery on glycemic control. Eligible patients who sign informed consent will be randomized in a 1:1 fashion to treatment sequence AB or treatment sequence BA. In the first study phase, participants randomized to sequence AB will receive 3 months of meals, followed by a 3 month washout period and a 3 month intervention period with no meals. Participants randomized to sequence BA will receive 3 months of no meals followed by a 3 month washout period and a 3 month intervention period with meals. Weight and blood pressure will be measured at weeks 0, 4, 8, 12, 24, 28, 32 and 36. During weeks 0, 12, 24 and 36 blood will be collected for measurement of lipids and glucose metabolism. Furthermore, a quality of life survey will be obtained during weeks 0, 12, 24 and 36. In addition, they will be asked to report how frequently they consumed the meals. During the study period participants will asked to keep a food diary to account for meals consumed that were not provided.
We hypothesize that there will be a greater 3-month improvement in HbA1c and other health parameters while receiving medically tailored meals compared to receiving no meals.
Study statuses change often. Please contact us for help.
Open for enrollment
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