Use of a Portion Control Food Tool to Induce Weight Loss in Obese Type 2 Diabetics.

Study Overview
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Brief Summary
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The purpose of this study was to determine whether a food portion control tool would be effective to result in weight loss in a group of overweight type 2 diabetics. We hypothesized that this tool would be effective to induce weight loss in these patients. We also hypothesized that diabetic control would be improved in patients using these plates.

Detailed Description
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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.

Official Title
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Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst Obese Type 2 Diabetics.

Conditions
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Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
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* Device: The Diet Plate (R) TM portion control plate and bowl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older diagnosis of type 2 diabetes mellitus body mass index of 30 or greater a member of the Diabetes Education Center in Calgary, AB, Canada, for at least 6 months prior to study enrollment Exclusion Criteria: taking a weight loss medication (sibutramine or orlistat) weight loss >10 lbs in 2 months preceding study enrolment consumption of dinner at restaurants more than twice weekly current diagnosis of cancer psychiatric illness under care of a psychiatrist surgery in the 3 months prior to the study, or expected during the study period history of bulimia or anorexia nervosa

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: The Diet Plate (R) TM portion control plate and bowl|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - change in glycosylated hemoglobin |  |  | 
| - change in serum cholesterol |  |  | 
| - change in blood pressure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, type 2 diabetes mellitus, portion control