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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Intervention Behavioral: A Chinese menu plan for type 2 diabetes
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 19
Completed 17
Not Completed 2
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description

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

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.

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Program completes only
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
66  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
8
  47.1%
Male
9
  52.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 17 participants
17
Age at Immigration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
45  (19)
Years in North America  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
21  (19)
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
11  (8)
Acculturation score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants
1.9  (0.4)
[1]
Measure Description: Suinn-Lew Asian Self Identity Acculturation Scale minimum = 1, maximum = 5; lower score indicates lower acculturation
1.Primary Outcome
Title Change in Energy Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: kcal
-299  (603)
2.Primary Outcome
Title Change in Carbohydrate Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percentage of total energy
0.4  (10.3)
3.Primary Outcome
Title Change in Protein Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percentage of total energy
1.7  (5.3)
4.Primary Outcome
Title Change in Total Fat Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percentage of total energy
0.6  (6.8)
5.Primary Outcome
Title Change in Saturated Fat Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percentage of total energy
0.1  (1.9)
6.Primary Outcome
Title Change in Dietary Fibre Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: grams
0.8  (13.9)
7.Primary Outcome
Title Change in Added Sucrose Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: percentage of total energy
0.2  (1.0)
8.Primary Outcome
Title Change in Sodium Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: milligrams
-275  (981)
9.Primary Outcome
Title Change in Calcium Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: milligrams
124  (341)
10.Primary Outcome
Title Change in Cholesterol Intake (3-day Food Record)
Hide Description Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: milligrams
11  (130)
11.Secondary Outcome
Title Change in Hemoglobin A1c (A1c)
Hide Description Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: % of A1c in blood
-0.13  (0.49)
12.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: kg/m2
-0.4  (0.8)
13.Secondary Outcome
Title Change in Waist Circumference
Hide Description Waist circumference measured pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: cm
-2.0  (2.5)
14.Secondary Outcome
Title Change in Fasting Triglyceride
Hide Description Fasting triglyceride measured pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.2  (88.8)
15.Secondary Outcome
Title Change in Fasting Total Cholesterol
Hide Description Fasting total cholesterol measured pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
-21.4  (28.2)
16.Secondary Outcome
Title Change in Fasting Low-density Lipoprotein Cholesterol
Hide Description Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
-18.4  (24.6)
17.Secondary Outcome
Title Change in Fasting High-density Lipoprotein Cholesterol
Hide Description Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
-2.8  (20.5)
Time Frame Total Number of Participants at Risk (e.g., serious and/or other [non-serious] adverse events) were not collected/assessed
Adverse Event Reporting Description Total Number of Participants at Risk (e.g., serious and/or other [non-serious] adverse events) were not collected/assessed. This trial involved working with participants to modify their diets based on nutrition education and a menu plan. Participants were not asked to eat any specific foods, they could modify their diets based on their own preferences; therefore we did not collect information on adverse events since none were anticipated.
 
Arm/Group Title A Chinese Menu Plan for Type 2 Diabetes
Hide Arm/Group Description

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

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.

All-Cause Mortality
A Chinese Menu Plan for Type 2 Diabetes
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A Chinese Menu Plan for Type 2 Diabetes
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A Chinese Menu Plan for Type 2 Diabetes
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Catherine Chan
Organization: University of Alberta
Phone: 780-492-9939
Responsible Party: Catherine Chan, University of Alberta
ClinicalTrials.gov Identifier: NCT02327429     History of Changes
Other Study ID Numbers: Pro00053775
First Submitted: December 18, 2014
First Posted: December 30, 2014
Results First Submitted: December 9, 2016
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017