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Completed

NCT Number: NCT00254124

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Education Center, Colonel Belcher Hospital

Calgary, Alberta, T2R 0K5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. - percentage change in body weight

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

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

Secondary outcomes

  1. - change in glycosylated hemoglobin

  2. - change in serum cholesterol

  3. - change in blood pressure

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Stewart Diabetes Education Fund

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Nov 15, 2005
Registry last updated
Nov 15, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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