The Alberta Diet: Effectiveness Study

The Alberta Diet: a Proposal for Its Implementation

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: PANDA intervention

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Alberta Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PANDA intervention; 12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Catherine B Chan, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: December 9, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: RES0013109