The Alberta Diet: Effectiveness Study

Type 2 Diabetes Clinical Trial

Official title:

The Alberta Diet: a Proposal for Its Implementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625507
• Other study ID #: RES0013109
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: August 9, 2015
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA intervention, will have improved compliance with the nutritional therapy recommendations of the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a) to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention program that promotes the individual factors required for effective self-management practices AND that explicitly incorporate strategies to improve food availability, accessibility and acceptability and (b) to use these interventions as a means to examine the relationships between food availability, accessibility, acceptability, adherence to Nutrition Therapy Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes, and speak/write English.

• Have attended a diabetes education session delivered by their healthcare provider.

Exclusion Criteria:

• Participants with type 1 diabetes, and those who are unable to speak English.

• People with end-stage renal disease or gastrointestinal diseases that require specialized diets will also be excluded.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• PANDA intervention
Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008

Locations

Country	Name	City	State
Canada	Alberta Diabetes Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Energy Intake	Measured using repeated 24 hour dietary recalls (pre and post-intervention)	4 months	No
Primary	Change in Macronutrient Intake	Measured using repeated 24 hour dietary recalls (pre and post-intervention)	3 months	No
Primary	Change in Nutrient Intake	Measured using repeated 24 hour dietary recalls (pre and post-intervention)	3 months	No
Secondary	Change in Hemoglobin A1c	a surrogate of blood glucose control	4 months	No
Secondary	Program Retention	attendance at meetings	3 months	No
Secondary	Change in Body Mass Index	Actual weight and height used to calculate BMI pre- and post-intervention	4 months	No
Secondary	Body Composition	body fat and fat-free mass	3 months	No
Secondary	Change in Blood Biomarkers	blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol	4 months	No
Secondary	Change in Perceived Dietary Adherence Questionnaire Score	Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.	4 months	No
Secondary	Food Acceptability	questionnaire based on items related to personal and cultural acceptability of the recommended diet	4 months	No
Secondary	Food Accessibility	questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes	4 months	No
Secondary	Food Availability	questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.	4 months	No
Secondary	Change in Waist Circumference	Measured using repeated 24 hour dietary recalls (pre and post-intervention	4 months	No