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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT00254124

Collaborator

Stewart Diabetes Education Fund (Other)

130

Enrollment

Location

Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Obesity	Device: The Diet Plate (R) TM portion control plate and bowl	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Apr 1, 2004

Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

- 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

- change in glycosylated hemoglobin []
- change in serum cholesterol []
- change in blood pressure []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Education Center, Colonel Belcher Hospital	Calgary	Alberta	Canada	T2R 0K5

Sponsors and Collaborators

University of Calgary
Stewart Diabetes Education Fund

Investigators

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