Use of a Portion Control Food Tool to Induce Weight Loss in Obese Type 2 Diabetics.
Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst Obese Type 2 Diabetics.
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Apr 2004
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedNovember 15, 2005
November 1, 2005
November 9, 2005
November 14, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
- 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 Outcomes (3)
- change in glycosylated hemoglobin
- change in serum cholesterol
- change in blood pressure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Stewart Diabetes Education Fundcollaborator
Study Sites (1)
Diabetes Education Center, Colonel Belcher Hospital
Calgary, Alberta, T2R 0K5, Canada
Related Publications (1)
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.
PMID: 17592101DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sue D Pedersen, MD, FRCPC
Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
- PRINCIPAL INVESTIGATOR
Greg A Kline, MD, FRCPC
Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 15, 2005
Study Start
April 1, 2004
Study Completion
December 1, 2004
Last Updated
November 15, 2005
Record last verified: 2005-11