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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Obesity

Keywords

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obesity type 2 diabetes mellitus portion control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Sue D Pedersen, MD, FRCPC

Role: STUDY_DIRECTOR

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

Greg A Kline, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Diabetes Education Center, Colonel Belcher Hospital

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 17592101 (View on PubMed)

Other Identifiers

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17585 (Grant ID#)

Identifier Type: -

Identifier Source: org_study_id