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

Purpose

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	Intervention
Type 2 Diabetes Mellitus Obesity	Device: The Diet Plate (R) TM portion control plate and bowl

MedlinePlus related topics:

Diabetes Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Calgary:

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

Estimated Enrollment:	130
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254124

Locations


Canada, Alberta
	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

More Information

Publications indexed to this study:

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.

Study ID Numbers:	17585 (Grant ID#)
First Received:	November 9, 2005
Last Updated:	November 14, 2005
ClinicalTrials.gov Identifier:	NCT00254124
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

obesity

type 2 diabetes mellitus

portion control

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Overweight

Body Weight

Signs and Symptoms

Diabetes Mellitus, Type 2

Weight Loss

Body Weight Changes

Nutrition Disorders

Overnutrition

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of Calgary Stewart Diabetes Education Fund
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00254124