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

Tracking Information

First Received Date ^ICMJE

November 9, 2005

Last Updated Date

November 14, 2005

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

- 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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00254124 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Type 2 Diabetes Mellitus
Obesity

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

Pedersen SD, Kang J, Kline GA. Portion control plate for weight loss in obese patients with type 2 diabetes mellitus: a controlled clinical trial. Arch Intern Med. 2007 Jun 25;167(12):1277-83.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00254124

Responsible Party

Study ID Numbers ^ICMJE

17585 (Grant ID#)

Study Sponsor ^ICMJE

University of Calgary

Collaborators ^ICMJE

Stewart Diabetes Education Fund

Investigators ^ICMJE

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

Information Provided By

University of Calgary

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP