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

Primary Purpose

Type 2 Diabetes Mellitus, Obesity

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring obesity, type 2 diabetes mellitus, portion control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Diabetes Education Center, Colonel Belcher Hospital

Outcomes

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

Full Information

NCT ID

NCT00254124

First Posted

November 9, 2005

Last Updated

November 14, 2005

Sponsor

University of Calgary

Collaborators

Stewart Diabetes Education Fund

1. Study Identification

Unique Protocol Identification Number

NCT00254124

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Calgary

Collaborators

Stewart Diabetes Education Fund

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Obesity

Keywords

obesity, type 2 diabetes mellitus, portion control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

- percentage change in body weight

Title

- proportion of each group that achieve a clinically significant (>=5%) reduction in body weight

Title

- prespecified per protocol analysis: same outcomes as above, looking at patients who were >=80% compliant with the intervention

Secondary Outcome Measure Information:

Title

- change in glycosylated hemoglobin

Title

- change in serum cholesterol

Title

- change in blood pressure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sue D Pedersen, MD, FRCPC

Organizational Affiliation

Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Greg A Kline, MD, FRCPC

Organizational Affiliation

Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Education Center, Colonel Belcher Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2R 0K5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

17592101

Citation

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. doi: 10.1001/archinte.167.12.1277.

Results Reference

derived

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

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