Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
obesity, type 2 diabetes mellitus, portion control
Brief summary
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
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.
Interventions
DEVICEThe Diet Plate (R) TM portion control plate and bowl
Sponsors
Stewart Diabetes Education Fund
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| - change in glycosylated hemoglobin | — |
| - change in serum cholesterol | — |
| - change in blood pressure | — |
Countries
Canada
Outcome results
None listed