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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity

• Registration Number: NCT00254124
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2004-04
• Study Completion: 2004-12
• Status Verified: 2005-11
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-14
• Last Update Submitted: 2005-11-14
• Study First Posted: 2005-11-15
• Last Update Posted: 2005-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- 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

Name	Time	Method
- change in glycosylated hemoglobin
- change in serum cholesterol
- change in blood pressure

Trial Locations

Locations (1)

Diabetes Education Center, Colonel Belcher Hospital; 🇨🇦 Calgary, Alberta, Canada