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Trial record 9 of 7520 for:    Type 2 Diabetes

Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A Chinese Menu Plan for Type 2 Diabetes

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.


Participant Flow:   Overall Study
    A Chinese Menu Plan for Type 2 Diabetes
STARTED   19 
COMPLETED   17 
NOT COMPLETED   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Program completes only

Reporting Groups
  Description
A Chinese Menu Plan for Type 2 Diabetes

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.


Baseline Measures
   A Chinese Menu Plan for Type 2 Diabetes 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  47.1% 
Male      9  52.9% 
Region of Enrollment 
[Units: Participants]
 
Canada   17 
Age at Immigration 
[Units: Years]
Mean (Standard Deviation)
 45  (19) 
Years in North America 
[Units: Years]
Mean (Standard Deviation)
 21  (19) 
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 11  (8) 
Acculturation score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.9  (0.4) 
[1] Suinn-Lew Asian Self Identity Acculturation Scale minimum = 1, maximum = 5; lower score indicates lower acculturation


  Outcome Measures

1.  Primary:   Change in Energy Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

2.  Primary:   Change in Carbohydrate Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

3.  Primary:   Change in Protein Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

4.  Primary:   Change in Total Fat Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

5.  Primary:   Change in Saturated Fat Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

6.  Primary:   Change in Dietary Fibre Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

7.  Primary:   Change in Added Sucrose Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

8.  Primary:   Change in Sodium Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

9.  Primary:   Change in Calcium Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

10.  Primary:   Change in Cholesterol Intake (3-day Food Record)   [ Time Frame: 12 weeks ]

11.  Secondary:   Change in Hemoglobin A1c (A1c)   [ Time Frame: 12 weeks ]

12.  Secondary:   Change in Body Mass Index (BMI)   [ Time Frame: 12 weeks ]

13.  Secondary:   Change in Waist Circumference   [ Time Frame: 12 weeks ]

14.  Secondary:   Change in Fasting Triglyceride   [ Time Frame: 12 weeks ]

15.  Secondary:   Change in Fasting Total Cholesterol   [ Time Frame: 12 weeks ]

16.  Secondary:   Change in Fasting Low-density Lipoprotein Cholesterol   [ Time Frame: 12 weeks ]

17.  Secondary:   Change in Fasting High-density Lipoprotein Cholesterol   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: cbchan@ualberta.ca



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