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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254124
• Other study ID #: 17585 (Grant ID#)
• Status: Completed
• Phase: N/A
• First received: November 9, 2005
• Last updated: November 14, 2005
• Start date: April 2004
• Est. completion date: December 2004

Study information

• Verified date: November 2005
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Device:
• The Diet Plate (R) TM portion control plate and bowl

Locations

Country	Name	City	State
Canada	Diabetes Education Center, Colonel Belcher Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Stewart Diabetes Education Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- percentage change in body weight
Primary	- proportion of each group that achieve a clinically significant (>=5%) reduction in body weight
Primary	- prespecified per protocol analysis: same outcomes as above, looking at patients who were >=80% compliant with the intervention
Secondary	- change in glycosylated hemoglobin
Secondary	- change in serum cholesterol
Secondary	- change in blood pressure