Use of a Portion Control Food Tool to Induce Weight Loss in Obese Type 2 Diabetics.
Type 2 Diabetes Mellitus
Device: The Diet Plate (R) TM portion control plate and bowl
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst Obese Type 2 Diabetics.|
- - percentage change in body weight
- - proportion of each group that achieve a clinically significant (>=5%) reduction in body weight
- - prespecified per protocol analysis: same outcomes as above, looking at patients who were >=80% compliant with the intervention
- - change in glycosylated hemoglobin
- - change in serum cholesterol
- - change in blood pressure
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||December 2004|
The prevalence of obesity is increasing worldwide. Portion size is known to be an important determinant of energy intake. However, to our knowledge, no clinical trials have previously been conducted which examine the efficacy of a food portion control tool to control caloric intake and thereby induce weight loss.
Most cases of type 2 diabetes can be attributed directly to obesity. Dietary caloric restriction has been shown to improve glycemic control by virtue of weight loss, with an additional benefit independent of weight loss.
Comparison: daily use of a food portion control tool plus usual care at a diabetes care center, compared to usual care alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254124
|Diabetes Education Center, Colonel Belcher Hospital|
|Calgary, Alberta, Canada, T2R 0K5|
|Study Director:||Sue D Pedersen, MD, FRCPC||Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada|
|Principal Investigator:||Greg A Kline, MD, FRCPC||Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada|