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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00254124
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : November 15, 2005
Sponsor:
Collaborator:
Stewart Diabetes Education Fund
Information provided by:
University of Calgary

Tracking Information
First Submitted Date  ICMJE November 9, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date November 15, 2005
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • - 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 No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • - change in glycosylated hemoglobin
  • - change in serum cholesterol
  • - change in blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Obesity
Intervention  ICMJE Device: The Diet Plate (R) TM portion control plate and bowl
Study Arms  ICMJE Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 14, 2005)		 130
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254124
Other Study ID Numbers  ICMJE 17585 (Grant ID#)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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
PRS Account 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