NCT02327429

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

December 18, 2014

Results QC Date

December 9, 2016

Last Update Submit

June 1, 2017

Conditions

Outcome Measures

Primary Outcomes (10)

  • Change in Energy Intake (3-day Food Record)

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

    12 weeks

  • Change in Carbohydrate Intake (3-day Food Record)

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

    12 weeks

  • Change in Protein Intake (3-day Food Record)

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

    12 weeks

  • Change in Total Fat Intake (3-day Food Record)

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

    12 weeks

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

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

    12 weeks

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

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

    12 weeks

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

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

    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

    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

    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

    12 weeks

Secondary Outcomes (7)

  • Change in Hemoglobin A1c (A1c)

    12 weeks

  • Change in Body Mass Index (BMI)

    12 weeks

  • Change in Waist Circumference

    12 weeks

  • Change in Fasting Triglyceride

    12 weeks

  • Change in Fasting Total Cholesterol

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

A Chinese menu plan for type 2 diabetes

EXPERIMENTAL

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

Behavioral: A Chinese menu plan for type 2 diabetes

Interventions

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.

A Chinese menu plan for type 2 diabetes

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Catherine Chan
Organization
University of Alberta

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 30, 2014

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 27, 2017

Results First Posted

June 27, 2017

Record last verified: 2017-06