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Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02327429
Recruitment Status : Completed
First Posted : December 30, 2014
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine Chan, University of Alberta

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: A Chinese menu plan for type 2 diabetes Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Test of a Chinese Menu Plan for Type 2 Diabetes
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Chinese menu plan for type 2 diabetes
All participants will be in the intervention arm for this pilot study
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.




Primary Outcome Measures :
  1. Change in Energy Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  2. Change in Carbohydrate Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  3. Change in Protein Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  4. Change in Total Fat Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  5. Change in Saturated Fat Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  6. Change in Dietary Fibre Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  7. Change in Added Sucrose Intake (3-day Food Record) [ Time Frame: 12 weeks ]
    Intake assessed pre-post intervention using a 3-day food record

  8. 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

  9. 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

  10. 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 Outcome Measures :
  1. Change in Hemoglobin A1c (A1c) [ Time Frame: 12 weeks ]
    Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months

  2. Change in Body Mass Index (BMI) [ Time Frame: 12 weeks ]
    Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months

  3. Change in Waist Circumference [ Time Frame: 12 weeks ]
    Waist circumference measured pre-post intervention from baseline to 3 months

  4. Change in Fasting Triglyceride [ Time Frame: 12 weeks ]
    Fasting triglyceride measured pre-post intervention from baseline to 3 months

  5. Change in Fasting Total Cholesterol [ Time Frame: 12 weeks ]
    Fasting total cholesterol measured pre-post intervention from baseline to 3 months

  6. Change in Fasting Low-density Lipoprotein Cholesterol [ Time Frame: 12 weeks ]
    Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months

  7. Change in Fasting High-density Lipoprotein Cholesterol [ Time Frame: 12 weeks ]
    Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Catherine Chan, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02327429     History of Changes
Other Study ID Numbers: Pro00053775
First Posted: December 30, 2014    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases