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临床试验/NCT02327429
NCT02327429已完成不适用

Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

University of Alberta0 个研究点目标入组 19 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
主要终点
Change in Calcium Intake (3-day Food Record)

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥ 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

排除标准

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

研究组 & 干预措施

A Chinese menu plan for type 2 diabetes

Experimental

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

干预措施: A Chinese menu plan for type 2 diabetes (Behavioral)

结局指标

主要结局

Change in Calcium Intake (3-day Food Record)

时间窗: 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)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Carbohydrate Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Protein Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Sodium Intake (3-day Food Record)

时间窗: 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)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Saturated Fat Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Dietary Fibre Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Added Sucrose Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Change in Cholesterol Intake (3-day Food Record)

时间窗: 12 weeks

Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Chan

Professor

University of Alberta

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Pilot Test of a Chinese Menu Plan for Type 2 Diabetes | 临床试验