Cooking Classes for Chinese Canadian Patients Living With Diabetes (CCDS)

April 23, 2019 updated by: David E. Harris, MD, Vancouver General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Richmond, British Columbia, Canada, V6X 1A2
        • Richmond Diabetes Education Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Enrolled in Type 2 Diabetes Education class in Mandarin or Cantonese at the Richmond Hospital Diabetes Education Centre.
  2. Ability to understand and participate in all scheduled diabetes education classes and/or cooking classes;
  3. Ability to complete the study questionnaires and standard of care glycemic bloodwork
  4. Prior diagnosis of diabetes mellitus type 2
  5. Persons who identify as chinese-canadian

Exclusion Criteria for this study includes:

  1. Inability to provide informed consent;
  2. Planned changes to diabetes medications during the study period, for example insulin titrations or oral medication adjustments;
  3. Currently enrolled in another study involving interventions related to diabetes care and management

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cooking class
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.
Dietary supplement: Chinese-canadian specific cooking classes
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.
Active Comparator: Control
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.
Other: Diabetes educational classes
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 6 months
Change in Hemoglobin A1C
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting lipid profile
Time Frame: 6 months
Change in fasting lipid profile
6 months
Renal function
Time Frame: 6 months
Change in Glomerular filtration rate
6 months
Albuminuria screen
Time Frame: 6 months
Change in urinary Albumin to Creatinine ratio
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diabetes self care activities
Time Frame: 3 months post intervention
Summary of Diabetes Self-Care Activities Measure (SDSCA) model
3 months post intervention
Diabetes self knowledge assessment
Time Frame: 3 months post intervention
Michigan Diabetes Knowledge Test
3 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vancouver General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Graydon S Meneilly, MD, FRCPC, UBC, Vancouver Coastal Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VCH RGH CCDS 1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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