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

U

University of Calgary

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00254124
17585 (Grant ID#)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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