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

This study has been completed.
Sponsor:
Collaborator:
Stewart Diabetes Education Fund
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00254124
First received: November 9, 2005
Last updated: November 14, 2005
Last verified: November 2005
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by University of Calgary:
obesity
type 2 diabetes mellitus
portion control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013