The Alberta Diet: Effectiveness Study

Study Overview
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Brief Summary
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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.

Official Title
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The Alberta Diet: a Proposal for Its Implementation

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: PANDA intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PANDA intervention<br>12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits. | Behavioral: PANDA intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Energy Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | 4 months | 
| Change in Macronutrient Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | 3 months | 
| Change in Nutrient Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c | a surrogate of blood glucose control | 4 months | 
| Program Retention | attendance at meetings | 3 months | 
| Change in Body Mass Index | Actual weight and height used to calculate BMI pre- and post-intervention | 4 months | 
| Body Composition | body fat and fat-free mass | 3 months | 
| Change in Blood Biomarkers | blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol | 4 months | 
| 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 | 
| Food Acceptability | questionnaire based on items related to personal and cultural acceptability of the recommended diet | 4 months | 
| Food Accessibility | questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes | 4 months | 
| Food Availability | questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes. | 4 months | 
| Change in Waist Circumference | Measured using repeated 24 hour dietary recalls (pre and post-intervention | 4 months |