Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327429
• Other study ID #: Pro00053775
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: April 13, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Description:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• = 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

Exclusion Criteria:

• severe gastrointestinal or renal problems that would preclude a diet according to the Nutrition Therapy Guidelines for Diabetes

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• A Chinese menu plan for type 2 diabetes
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary intake (3-day food record)	Intake assessed pre-post intervention using a 3-day food record	12 weeks	No
Secondary	Hemoglobin A1c (A1c)	Hemoglobin A1c measured in capillary blood pre-post intervention	12 weeks	No
Secondary	Body mass index (BMI)	Body mass index calculated from weight measured pre-post and height measured pre-intervention	12 weeks	No
Secondary	Waist circumference	Waist circumference measured pre-post intervention	12 weeks	No
Secondary	Lipid profile	Measurement of fasting serum triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL) and low density lipoprotein cholesterol (LDL)	12 weeks	No