The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

Eligible volunteers are randomly assigned to a treatment group consisting of a pre-packaged,
portion controlled meal plan plus a group behavior modification program or to a control
group that consists of a group diabetes support and education (DSE) program. Random
assignment will be stratified by whether or not a subject is taking insulin at baseline,
which will be included as a covariate in all subsequent analyses. Treatment assignments are
unmasked. At the end of 24 weeks both groups will have completed 9 group sessions (weeks 0,
1, 2, 4, 8, 12, 16, 20 and 24). At week 16, each participant will meet individually with
the study physician to review their progress to date. These meetings will take place at the
week 16 group visit. The PCD program is aimed at achieving and maintaining a decrease in
weight and providing a group behavior modification program from 0-24 weeks. The DSE program
is aimed at providing diabetes support and education from weeks 0-24. A Certified Diabetes
Educator (CDE) will review the effects of diet and weight loss, exercise, and medications on
blood glucose levels among all participants at the individual session before any changes in
dietary intake or exercise are prescribed. Participants will be counseled on strategies to
prevent hypoglycemia and will be given a blood glucose meter and strips and instructed to
measure their blood glucose at least two times per day while participating in the study. In
addition, the causes, symptoms and treatment of hypoglycemia will be reviewed including when
to contact their health care provider.