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Clinical Trials/NCT02327429
NCT02327429CompletedNot Applicable

Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

University of Alberta0 sites19 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Primary Endpoint
Change in Calcium Intake (3-day Food Record)

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A Chinese menu plan for type 2 diabetes

Experimental

All participants will be in the intervention arm for this pilot study

Intervention: A Chinese menu plan for type 2 diabetes (Behavioral)

Outcomes

Primary Outcomes

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 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 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 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 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

Secondary Outcomes

  • Change in Fasting Triglyceride(12 weeks)
  • Change in Fasting Low-density Lipoprotein Cholesterol(12 weeks)
  • Change in Hemoglobin A1c (A1c)(12 weeks)
  • Change in Body Mass Index (BMI)(12 weeks)
  • Change in Waist Circumference(12 weeks)
  • Change in Fasting Total Cholesterol(12 weeks)
  • Change in Fasting High-density Lipoprotein Cholesterol(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Catherine Chan

Professor

University of Alberta

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