An interventional study of Portion controlled diet and Diabetes Support and Education in Obesity, sponsored by Temple University. Completed at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-01.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
The purpose of this research study to find out whether a pre-packaged, portion controlled diet with a group behavior modification program or group diabetes support and education, is a safe and effective way for people with type 2 diabetes to lose weight and manage their diabetes.
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.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Diabetes Support and Education
behavior modification
Behavioral: Portion controlled diet
Participants learn skills for changing nutritional and lifestyle habits and diabetes management follow a program that includes eating a pre-packaged, portion controlled meal for weight loss in addition to attending the behavior modification groups
Also known as: PCD
The DSE groups will consist of educational sessions offered for diabetes support and education which will include sessions on diet/nutrition, exercise, foot care and living with diabetes.
Also known as: DSE
Change in weight at 3 and 6 months
Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.
Time frame: Baseline, 3 & 6 months
Change in HbA1C at 3 and 6 months
Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes.
Time frame: Baseline, 3 & 6 Month
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Temple University