Clinical trial NCT00254124: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: obesity
type 2 diabetes mellitus
portion control
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Stewart Diabetes Education Fund
First posted: 2005-11-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: - percentage change in body weight
measure: - proportion of each group that achieve a clinically significant (>=5%) reduction in body weight
measure: - prespecified per protocol analysis: same outcomes as above, looking at patients who were >=80% compliant with the intervention
Secondary outcomes:
measure: - change in glycosylated hemoglobin
measure: - change in serum cholesterol
measure: - change in blood pressure
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Diabetes Education Center, Colonel Belcher Hospital
state: Alberta
Study officials:
affiliation: Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
name: Sue D Pedersen, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
name: Greg A Kline, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.