Type 2 DiabetesNCT02327429
Pilot Test of a Chinese Menu Plan for Type 2 Diabetes
A study testing A Chinese menu plan for type 2 diabetes in people with Type 2 Diabetes, run by University of Alberta.
Trial summary
In Canada, there is a fast-growing population with diabetes, and the majority of diabetes cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular diseases, eye disease and foot disease, impair the quality of life and life expectancy. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- A Chinese menu plan for type 2 diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 35 years of age;
- diagnosed with T2D or prediabetes;
- baseline hemoglobin A1C ≥ 6.0%;
- treatment with lifestyle, and/or oral hypoglycemic medications or insulin;
- Chinese origin;
- able to read and write Chinese or English
Who cannot join
- severe gastrointestinal or renal problems that would preclude a diet according to the Nutrition Therapy Guidelines for Diabetes
About this study
In Canada, there is a fast-growing population with diabetes, and the majority of diabetes cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular diseases, eye disease and foot disease, impair the quality of life and life expectancy.
Chinese are the second largest visible minority in Canada. The diabetes incidence increased much more rapidly in the Canadian population of Chinese origin compared with that of European origin in past decades. Cultural factors are very likely to affect individual behaviour in diabetes treatment. Both international and Canadian diabetes organizations have recognized the importance of taking into account the cultural background and individual preferences in diabetes treatment.
Read more
However, there lacks cultural relevant nutritional recommendations or guidelines for Chinese Canadians except some literally translated materials which may not be culturally relevant. In order to fill the gap, the investigators have developed a Chinese menu plan that includes commonly consumed Chinese dishes with nutrients breakdown and cooking tips to provide guidance for patients in their daily meal planning. This menu plan is a cultural translation of the Canadian nutritional guidelines, which is urgently needed among Chinese immigrants with T2D in Edmonton, according to our previous needs assessment.
In this pilot test, the investigators will examine the feasibility and effectiveness of the Chinese menu plan. Twenty Chinese with T2D in Edmonton will be recruited to use the menu plan for 3 consecutive months and relevant indices of T2D will be tested as indicators of effectiveness. Feedback from participants will be obtained through one-on-one interviews and appropriate modifications will be made to the menu plan.
Read the detailed description
- Objectives The objectives of this study are to assess the feasibility of the Chinese menu plan in Chinese immigrants with type 2 diabetes (T2D), and to assess the effectiveness of the menu plan in terms of nutrient intakes, glycemic control, weight management and other biochemical indices.
- Background 2.1 Prevalence of diabetes According to Statistics Canada, the diabetes population in 2010 increased by 39.0% compared with that in 2005, while the total population increased by 4.8% in the five years. Diabetes is the sixth leading cause of death in Canada and it brings complications such as cardiovascular, renal, foot and eye diseases, which cause disabilities and reduction in life expectancy. T2D comprises 90% of diabetes population worldwide, and is largely a result of excess body weight and physical inactivity. Ethnic Chinese is the second largest visible minority in Canada, and comprises 3.9% and 5.2% of the total population of Canada and of Edmonton, respectively. It has been reported that Chinese Canadians are at high risk of diabetes. This warrants more attention to diabetes management among ethnic Chinese in Canada. 2.2 Importance of culturally relevant interventions Self-care during chronic disease is better facilitated when cultural competence and congruency is incorporated in the management approach. Both international and Canadian guidelines recognize the importance of individualizing treatment based on culture. Chinese Canadians especially the first generations, usually have distinct dietary pattern from the Western diet in terms of food selections and combinations, cooking methods, and the number of dishes per meal, etc. So a general Canadian menu plan is not applicable to ethnic Chinese. Although dietary acculturation happens following immigration, which results in a mixture of traditional and Western diet and cooking techniques in immigrants, traditional diet still takes larger proportion. Diabetes research on Chinese Canadians is scarce and so is Chinese-culture specific nutritional guidelines in Canada. We have developed a culturally relevant menu plan for Chinese Canadians based on the needs assessment and recommendations from Canadian Diabetes Association guidelines and Eating Well with Canada's Food Guide. This pilot study is to test the effectiveness of the menu plan, which can become a practical tool for diabetes self-management in the ethnic Chinese population.
- Methods and procedures
We will recruit 20 Chinese individuals with T2D in Edmonton to the pilot test. Inclusion criteria are: ≥ 35 years of age; diagnosed with T2D or prediabetes; beginning hemoglobin A1C ≥ 6.0%; treatment with lifestyle, and/or oral hypoglycemic medications or insulin; Chinese origin; able to read and write Chinese or English. Exclusion criteria are: severe gastrointestinal or renal problems that would preclude them eating according to the Nutrition Therapy Guidelines for Diabetes.
3.1 Baseline assessment
Before the 12-week intervention, baseline assessment will be conducted on all participants, including measurement of A1C, height, weight, waist circumference and body composition. Fasting blood samples will be collected for lipid profile measurement. Demographic characteristics, diabetes treatment, self-care activities, physical activity and perceived dietary adherence will be assessed using questionnaires. Participants will three-day food records for dietary intake analysis.
3.2 Adoption
Participants will be asked to follow the menu plan for 12 weeks and keep weekly records of their use of the menu plan. Goal setting will be applied to facilitate adoption. During the first four weeks, the study coordinator will hold one-on-one weekly interviews with each participant to provide feedback and education about the menu plan. Obstacles and strategies will be discussed. During the last eight weeks, only one interview per month will be scheduled to address any problems that participants may have and to help monitor their goal achievement. Participants will be asked to complete another 3-day food record during the last week of the test.
3.3 Final assessment
After study completion, A1C, weight, waist circumference and body composition will be measured within 1 week. A fasting blood sample will be collected to measure lipid profile. Some of the baseline questionnaires including diabetes treatment and perceived dietary adherence will be repeated, and an exit survey will be completed. The final three-day food records will be collected from participants. Focus groups will be conducted to gather information on participants' experiences and perceived benefits of, and barriers and facilitators to following the menu plan. Feedback will be collected as one of the references for possible modification of the menu plan.
3.4 Follow-up
Email or telephone follow-up will be conducted 2 months after study completion to document whether participants continue to use the menu plan. This will be one of the indicators for the long-term feasibility of the menu plan.
- Conditions
- Type 2 Diabetes
- Being tested
- A Chinese menu plan for type 2 diabetes
- 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.
A Chinese menu plan for type 2 diabetesBehavioural
The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.
| Study group | Role | What they receive |
|---|---|---|
| A Chinese menu plan for type 2 diabetes | Experimental | All participants will be in the intervention arm for this pilot study Receives: Behavioral: A Chinese menu plan for type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energy Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Carbohydrate Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Protein Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Total Fat Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Saturated Fat Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Dietary Fibre Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Added Sucrose Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record
Measured: 12 weeks
Change in Sodium Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Measured: 12 weeks
Change in Calcium Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Measured: 12 weeks
Change in Cholesterol Intake (3-day Food Record)
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Measured: 12 weeks
Secondary outcomes (7)
Change in Hemoglobin A1c (A1c)
Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months
Measured: 12 weeks
Change in Body Mass Index (BMI)
Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months
Measured: 12 weeks
Change in Waist Circumference
Waist circumference measured pre-post intervention from baseline to 3 months
Measured: 12 weeks
Change in Fasting Triglyceride
Fasting triglyceride measured pre-post intervention from baseline to 3 months
Measured: 12 weeks
Change in Fasting Total Cholesterol
Fasting total cholesterol measured pre-post intervention from baseline to 3 months
Measured: 12 weeks
Change in Fasting Low-density Lipoprotein Cholesterol
Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months
Measured: 12 weeks
Change in Fasting High-density Lipoprotein Cholesterol
Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Chan, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327429
- Sponsor's protocol ID
- Pro00053775
- Status last verified
- Jun 2017
- First submitted
- 18 Dec 2014
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Chinese Menu Plan for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02327429
- Acronym / sponsor ID
- Pro00053775
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Canada, there is a fast-growing population with diabetes, and the majority of diabetes cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular diseases, eye disease and foot disease, impair the quality of life and life expectancy.
Chinese are the second largest visible minority in Canada. The diabetes incidence increased much more rapidly in the Canadian population of Chinese origin compared with that of European origin in past decades. Cultural factors are very likely to affect individual behaviour in diabetes treatment. Both international and Canadian diabetes organizations have recognized the importance of taking into account the cultural background and individual preferences in diabetes treatment.
However, there lacks cultural relevant nutritional recommendations or guidelines for Chinese Canadians except some literally translated materials which may not be culturally relevant. In order to fill the gap, the investigators have developed a Chinese menu plan that includes commonly consumed Chinese dishes with nutrients breakdown and cooking tips to provide guidance for patients in their daily meal planning. This menu plan is a cultural translation of the Canadian nutritional guidelines, which is urgently needed among Chinese immigrants with T2D in Edmonton, according to our previous needs assessment.
In this pilot test, the investigators will examine the feasibility and effectiveness of the Chinese menu plan. Twenty Chinese with T2D in Edmonton will be recruited to use the menu plan for 3 consecutive months and relevant indices of T2D will be tested as indicators of effectiveness. Feedback from participants will be obtained through one-on-one interviews and appropriate modifications will be made to the menu plan.
Detailed description
- Objectives The objectives of this study are to assess the feasibility of the Chinese menu plan in Chinese immigrants with type 2 diabetes (T2D), and to assess the effectiveness of the menu plan in terms of nutrient intakes, glycemic control, weight management and other biochemical indices.
- Background 2.1 Prevalence of diabetes According to Statistics Canada, the diabetes population in 2010 increased by 39.0% compared with that in 2005, while the total population increased by 4.8% in the five years. Diabetes is the sixth leading cause of death in Canada and it brings complications such as cardiovascular, renal, foot and eye diseases, which cause disabilities and reduction in life expectancy. T2D comprises 90% of diabetes population worldwide, and is largely a result of excess body weight and physical inactivity. Ethnic Chinese is the second largest visible minority in Canada, and comprises 3.9% and 5.2% of the total population of Canada and of Edmonton, respectively. It has been reported that Chinese Canadians are at high risk of diabetes. This warrants more attention to diabetes management among ethnic Chinese in Canada. 2.2 Importance of culturally relevant interventions Self-care during chronic disease is better facilitated when cultural competence and congruency is incorporated in the management approach. Both international and Canadian guidelines recognize the importance of individualizing treatment based on culture. Chinese Canadians especially the first generations, usually have distinct dietary pattern from the Western diet in terms of food selections and combinations, cooking methods, and the number of dishes per meal, etc. So a general Canadian menu plan is not applicable to ethnic Chinese. Although dietary acculturation happens following immigration, which results in a mixture of traditional and Western diet and cooking techniques in immigrants, traditional diet still takes larger proportion. Diabetes research on Chinese Canadians is scarce and so is Chinese-culture specific nutritional guidelines in Canada. We have developed a culturally relevant menu plan for Chinese Canadians based on the needs assessment and recommendations from Canadian Diabetes Association guidelines and Eating Well with Canada's Food Guide. This pilot study is to test the effectiveness of the menu plan, which can become a practical tool for diabetes self-management in the ethnic Chinese population.
- Methods and procedures
We will recruit 20 Chinese individuals with T2D in Edmonton to the pilot test. Inclusion criteria are: ≥ 35 years of age; diagnosed with T2D or prediabetes; beginning hemoglobin A1C ≥ 6.0%; treatment with lifestyle, and/or oral hypoglycemic medications or insulin; Chinese origin; able to read and write Chinese or English. Exclusion criteria are: severe gastrointestinal or renal problems that would preclude them eating according to the Nutrition Therapy Guidelines for Diabetes.
3.1 Baseline assessment
Before the 12-week intervention, baseline assessment will be conducted on all participants, including measurement of A1C, height, weight, waist circumference and body composition. Fasting blood samples will be collected for lipid profile measurement. Demographic characteristics, diabetes treatment, self-care activities, physical activity and perceived dietary adherence will be assessed using questionnaires. Participants will three-day food records for dietary intake analysis.
3.2 Adoption
Participants will be asked to follow the menu plan for 12 weeks and keep weekly records of their use of the menu plan. Goal setting will be applied to facilitate adoption. During the first four weeks, the study coordinator will hold one-on-one weekly interviews with each participant to provide feedback and education about the menu plan. Obstacles and strategies will be discussed. During the last eight weeks, only one interview per month will be scheduled to address any problems that participants may have and to help monitor their goal achievement. Participants will be asked to complete another 3-day food record during the last week of the test.
3.3 Final assessment
After study completion, A1C, weight, waist circumference and body composition will be measured within 1 week. A fasting blood sample will be collected to measure lipid profile. Some of the baseline questionnaires including diabetes treatment and perceived dietary adherence will be repeated, and an exit survey will be completed. The final three-day food records will be collected from participants. Focus groups will be conducted to gather information on participants' experiences and perceived benefits of, and barriers and facilitators to following the menu plan. Feedback will be collected as one of the references for possible modification of the menu plan.
3.4 Follow-up
Email or telephone follow-up will be conducted 2 months after study completion to document whether participants continue to use the menu plan. This will be one of the indicators for the long-term feasibility of the menu plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Chinese menu plan for type 2 diabetes | Experimental | Behavioral: A Chinese menu plan for type 2 diabetesAll participants will be in the intervention arm for this pilot study |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 35 years of age;
- diagnosed with T2D or prediabetes;
- baseline hemoglobin A1C ≥ 6.0%;
- treatment with lifestyle, and/or oral hypoglycemic medications or insulin;
- Chinese origin;
Key exclusion criteria (1 listed)
- severe gastrointestinal or renal problems that would preclude a diet according to the Nutrition Therapy Guidelines for Diabetes
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 |
|---|---|---|
| A Chinese menu plan for type 2 diabetesThe intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet. | Behavioural | A Chinese menu plan for type 2 diabetes |
Primary outcome
Change in Energy Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Carbohydrate Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Protein Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Total Fat Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Saturated Fat Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Dietary Fibre Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Added Sucrose Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record
Change in Sodium Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Change in Calcium Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Change in Cholesterol Intake (3-day Food Record)
Time frame: 12 weeks
Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
7 secondary outcomes
Change in Hemoglobin A1c (A1c)
Time frame: 12 weeks
Change in Body Mass Index (BMI)
Time frame: 12 weeks
Change in Waist Circumference
Time frame: 12 weeks
Change in Fasting Triglyceride
Time frame: 12 weeks
Change in Fasting Total Cholesterol
Time frame: 12 weeks
Change in Fasting Low-density Lipoprotein Cholesterol
Time frame: 12 weeks
Change in Fasting High-density Lipoprotein Cholesterol
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A Chinese menu plan for type 2 diabetes in people with Type 2 Diabetes, run by University of Alberta.
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 6 inclusion and 1 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Energy Intake (3-day Food Record) (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.