Type 2 Diabetes MellitusNCT00254124
Use of a Portion Control Food Tool to Induce Weight Loss in Obese Type 2 Diabetics.
A study of Type 2 Diabetes Mellitus and Obesity, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Diabetes Education Center, Colonel Belcher Hospital
Calgary, Alberta, T2R 0K5
About this study
Official title: Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- The Diet Plate (R) TM portion control plate and bowl
- Keywords
- obesity, type 2 diabetes mellitus, portion control
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Diet Plate (R) TM portion control plate and bowlDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startApr 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Stewart Diabetes Education Fund
- Investigators
- Sue D Pedersen, MD, FRCPC, Study director, Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, CanadaGreg A Kline, MD, FRCPC, Principal investigator, Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254124
- Sponsor's protocol ID
- 17585 (Grant ID#)
- Status last verified
- Nov 2005
- First submitted
- 9 Nov 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Publications
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.
PubMed 17592101
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst Obese Type 2 Diabetics.
- ClinicalTrials.gov ID
- NCT00254124
- Acronym / sponsor ID
- 17585 (Grant ID#)
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- obesity, type 2 diabetes mellitus, portion control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Stewart Diabetes Education Fund
- Study start
- Apr 2004
- Study completion
- Dec 2004
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Diet Plate (R) TM portion control plate and bowl | Device | – |
Primary outcome
- 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
3 secondary outcomes
- change in glycosylated hemoglobin
- change in serum cholesterol
- change in blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2005.
- Derived from this study: PubMed 17592101Pedersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue D Pedersen, MD, FRCPC study director
Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
Greg A Kline, MD, FRCPC principal investigator
Division of Endocrinology and Metabolism, University of Calgary, Calgary, AB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes Mellitus and Obesity, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- percentage change in body weight. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2005.