Diabetes Mellitus Type 2CCDSNCT02666924
Cooking Classes for Chinese Canadian Patients Living With Diabetes
A study testing Chinese-canadian specific cooking classes and Diabetes educational classes in people with Diabetes Mellitus Type 2, run by Vancouver General Hospital at 1 site in Canada.
Trial summary
This study aims to determine whether providing language and culturally appropriate cooking classes to Chinese Canadian individuals with diabetes will help to improve their diabetes control, knowledge and self care activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Chinese-canadian specific cooking classes and Diabetes educational classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2017to 31 Dec 2018
- 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
- Enrolled in Type 2 Diabetes Education class in Mandarin or Cantonese at the Richmond Hospital Diabetes Education Centre.
- Ability to understand and participate in all scheduled diabetes education classes and/or cooking classes;
- Ability to complete the study questionnaires and standard of care glycemic bloodwork
- Prior diagnosis of diabetes mellitus type 2
- Persons who identify as chinese-canadian
Who cannot join
- Inability to provide informed consent;
- Planned changes to diabetes medications during the study period, for example insulin titrations or oral medication adjustments;
- Currently enrolled in another study involving interventions related to diabetes care and management
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richmond Diabetes Education Center
Richmond, British Columbia, V6X 1A2
About this study
Official title: The Effects of Attending Language and Culturally Appropriate Cooking Classes on Glycemic Control, Diabetes Knowledge and Self-management in Chinese-Canadian Patients Living With Diabetes Mellitus Type Two: A Pilot Study
This study aims to determine whether providing language and culturally appropriate cooking classes to Chinese Canadian individuals with diabetes will help to improve their diabetes control, knowledge and self care activities. The control group will receive current standard care of two diabetes education classes led by the dietitian and nurse. The intervention group will receive standard care and a series of four interactive cooking classes led by a dietitian, nurse and chef. We will compare the results of blood work, knowledge and self care questionnaires between the two groups to determine whether there are any benefits to attending these cooking classes.
Read the detailed description
This is a study attempting to investigate whether a cooking class intervention will lead to improved glycemic control in Chinese-Canadian people in the community of Richmond, British Columbia. By providing culturally appropriate cooking classes, tailored to Chinese foods, culture and population, we will be able to address specific challenges that affect ethnic Chinese patients with diabetes living in Canada. This innovative program would serve to meet a need that is currently unmet in the community, by providing a hands-on opportunity for participants to try different foods, learn various culturally appropriate recipes, prepare meals together and learn how the foods being eaten affects blood glucose. These classes would also serve as an avenue to reinforce various diabetes self-management activities - including self-monitoring of blood glucose and the effects of physical activity. Also, participants may benefit from peer support and the sharing of experiences and advice with each other. Through this research study, we hope to demonstrate improved diabetes knowledge, self-care management and glycemic control for patients who attend the cooking classes.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Chinese-canadian specific cooking classes, Diabetes educational classes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese-canadian specific cooking classesDietary supplement
Series of four, four-hour cooking classes, occurring monthly for four months. Each of the cooking classes in the series will have diabetes self-management learning objectives: food choices, meal planning and preparation, portion control, self-monitoring of blood glucose levels and physical activity.
Diabetes educational classesOther
Series of two, four-hour diabetes education classes, occurring weekly for two weeks. Each class is run by a registered dietitian and nurse, trained as clinical diabetes educators, as per standards of the canadian diabetes association. Classes include focused teaching of the background of diabetes, dietary recommendations for diabetes, lifestyle recommendations for diabetes, medications for diabetes, and general standard of living recommended for diabetes mellitus type 2.
| Study group | Role | What they receive |
|---|---|---|
| Cooking class | Experimental | The addition of diabetes cooking educational classes to standard diabetes education classes. Cooking classes are a series of four, four-hour sessions. These cooking classes will be led by a registered dietitian, a registered nurse and a chinese chef. Conducted in Mandarin or Cantonese. The cooking education focus is culturally specific teaching for Chinese-Canadian persons living with diabetes. Receives: Dietary Supplement: Chinese-canadian specific cooking classes |
| Control | Active comparator | Type 2 diabetes educational classes, consisting of two sessions, one week apart, four-hour classes. These classes are taught by a registered dietitian and nurse, in Mandarin or Cantonese. Receives: Other: Diabetes educational classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in Hemoglobin A1C
Measured: 6 months
Secondary outcomes (3)
Fasting lipid profile
Change in fasting lipid profile
Measured: 6 months
Renal function
Change in Glomerular filtration rate
Measured: 6 months
Albuminuria screen
Change in urinary Albumin to Creatinine ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start31 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E. Harris, MD, Vancouver General Hospital
- Investigators
- Graydon S Meneilly, MD, FRCPC, Study director, UBC, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666924
- Sponsor's protocol ID
- VCH RGH CCDS 1.1
- Acronym
- CCDS
- Status last verified
- Apr 2019
- First submitted
- 24 Jan 2016
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
PubMed 23089999Chan YM, Molassiotis A. The relationship between diabetes knowledge and compliance among Chinese with non-insulin dependent diabetes mellitus in Hong Kong. J Adv Nurs. 1999 Aug;30(2):431-8. doi: 10.1046/j.1365-2648.1999.01098.x.
PubMed 10457246Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
PubMed 10895844Yin Xu, Savage C, Toobert D, Wei Pan, Whitmer K. Adaptation and testing of instruments to measure diabetes self-management in people with type 2 diabetes in mainland China. J Transcult Nurs. 2008 Jul;19(3):234-42. doi: 10.1177/1043659608319239.
PubMed 18579863Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706.
PubMed 9589228Fitzgerald JT, Funnell MM, Anderson RM, Nwankwo R, Stansfield RB, Piatt GA. Validation of the Revised Brief Diabetes Knowledge Test (DKT2). Diabetes Educ. 2016 Apr;42(2):178-87. doi: 10.1177/0145721715624968. Epub 2016 Jan 14.
PubMed 26769757
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Attending Language and Culturally Appropriate Cooking Classes on Glycemic Control, Diabetes Knowledge and Self-management in Chinese-Canadian Patients Living With Diabetes Mellitus Type Two: A Pilot Study
- ClinicalTrials.gov ID
- NCT02666924
- Acronym / sponsor ID
- CCDS / VCH RGH CCDS 1.1
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jan 2016 (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.
This study aims to determine whether providing language and culturally appropriate cooking classes to Chinese Canadian individuals with diabetes will help to improve their diabetes control, knowledge and self care activities. The control group will receive current standard care of two diabetes education classes led by the dietitian and nurse. The intervention group will receive standard care and a series of four interactive cooking classes led by a dietitian, nurse and chef. We will compare the results of blood work, knowledge and self care questionnaires between the two groups to determine whether there are any benefits to attending these cooking classes.
Detailed description
This is a study attempting to investigate whether a cooking class intervention will lead to improved glycemic control in Chinese-Canadian people in the community of Richmond, British Columbia. By providing culturally appropriate cooking classes, tailored to Chinese foods, culture and population, we will be able to address specific challenges that affect ethnic Chinese patients with diabetes living in Canada. This innovative program would serve to meet a need that is currently unmet in the community, by providing a hands-on opportunity for participants to try different foods, learn various culturally appropriate recipes, prepare meals together and learn how the foods being eaten affects blood glucose. These classes would also serve as an avenue to reinforce various diabetes self-management activities - including self-monitoring of blood glucose and the effects of physical activity. Also, participants may benefit from peer support and the sharing of experiences and advice with each other. Through this research study, we hope to demonstrate improved diabetes knowledge, self-care management and glycemic control for patients who attend the cooking classes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooking class | Experimental | Dietary Supplement: Chinese-canadian specific cooking classesThe addition of diabetes cooking educational classes to standard diabetes education classes. Cooking classes are a series of four, four-hour sessions. These cooking classes will be led by a registered dietitian, a registered nurse and a chinese chef. Conducted in Mandarin or Cantonese. The cooking education focus is culturally specific teaching for Chinese-Canadian persons living with diabetes. |
| Control | Active comparator | Other: Diabetes educational classesType 2 diabetes educational classes, consisting of two sessions, one week apart, four-hour classes. These classes are taught by a registered dietitian and nurse, in Mandarin or Cantonese. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrolled in Type 2 Diabetes Education class in Mandarin or Cantonese at the Richmond Hospital Diabetes Education Centre.
- Ability to understand and participate in all scheduled diabetes education classes and/or cooking classes;
- Ability to complete the study questionnaires and standard of care glycemic bloodwork
- Prior diagnosis of diabetes mellitus type 2
- Persons who identify as chinese-canadian
Key exclusion criteria (3 listed)
- Inability to provide informed consent;
- Planned changes to diabetes medications during the study period, for example insulin titrations or oral medication adjustments;
- Currently enrolled in another study involving interventions related to diabetes care and management
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 |
|---|---|---|
| Chinese-canadian specific cooking classesSeries of four, four-hour cooking classes, occurring monthly for four months. Each of the cooking classes in the series will have diabetes self-management learning objectives: food choices, meal planning and preparation, portion control, self-monitoring of blood glucose levels and physical activity. | Dietary supplement | Cooking class |
| Diabetes educational classesSeries of two, four-hour diabetes education classes, occurring weekly for two weeks. Each class is run by a registered dietitian and nurse, trained as clinical diabetes educators, as per standards of the canadian diabetes association. Classes include focused teaching of the background of diabetes, dietary recommendations for diabetes, lifestyle recommendations for diabetes, medications for diabetes, and general standard of living recommended for diabetes mellitus type 2. | Other | Control |
Primary outcome
Glycemic control
Time frame: 6 months
Change in Hemoglobin A1C
3 secondary outcomes
Fasting lipid profile
Time frame: 6 months
Renal function
Time frame: 6 months
Albuminuria screen
Time frame: 6 months
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 25 Apr 2019.
- Background: PubMed 23089999Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
- Background: PubMed 10457246Chan YM, Molassiotis A. The relationship between diabetes knowledge and compliance among Chinese with non-insulin dependent diabetes mellitus in Hong Kong. J Adv Nurs. 1999 Aug;30(2):431-8. doi: 10.1046/j.1365-2648.1999.01098.x.
- Background: PubMed 10895844Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
- Background: PubMed 18579863Yin Xu, Savage C, Toobert D, Wei Pan, Whitmer K. Adaptation and testing of instruments to measure diabetes self-management in people with type 2 diabetes in mainland China. J Transcult Nurs. 2008 Jul;19(3):234-42. doi: 10.1177/1043659608319239.
- Background: PubMed 9589228Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706.
- Background: PubMed 26769757Fitzgerald JT, Funnell MM, Anderson RM, Nwankwo R, Stansfield RB, Piatt GA. Validation of the Revised Brief Diabetes Knowledge Test (DKT2). Diabetes Educ. 2016 Apr;42(2):178-87. doi: 10.1177/0145721715624968. Epub 2016 Jan 14.
- Individual participant dataSharing planned: No
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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.
Graydon S Meneilly, MD, FRCPC study director
UBC, Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese-canadian specific cooking classes and Diabetes educational classes in people with Diabetes Mellitus Type 2, run by Vancouver General Hospital 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 5 inclusion and 3 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 25 Apr 2019. 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?
Glycemic control (time frame: 6 months). 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 NCT02666924, which also lists 6 linked publications.
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 25 Apr 2019.