The Alberta Diet: Effectiveness Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01625507
First received: June 19, 2012
Last updated: August 9, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Behavioral: PANDA intervention
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Alberta Diet: a Proposal for Its Implementation

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Total Energy Intake [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured using repeated 24 hour dietary recalls (pre and post-intervention)

  • Change in Macronutrient Intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured using repeated 24 hour dietary recalls (pre and post-intervention)

  • Change in Nutrient Intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured using repeated 24 hour dietary recalls (pre and post-intervention)


Secondary Outcome Measures:
  • Change in Hemoglobin A1c [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    a surrogate of blood glucose control

  • Program Retention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    attendance at meetings

  • Change in Body Mass Index [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Actual weight and height used to calculate BMI pre- and post-intervention

  • Body Composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    body fat and fat-free mass

  • Change in Blood Biomarkers [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol

  • Change in Perceived Dietary Adherence Questionnaire Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Food Acceptability [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire based on items related to personal and cultural acceptability of the recommended diet

  • Food Accessibility [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes

  • Food Availability [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.

  • Change in Waist Circumference [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured using repeated 24 hour dietary recalls (pre and post-intervention


Enrollment: 73
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625507

Locations
Canada, Alberta
Alberta Diabetes Institute
Edmonton, Alberta, Canada, T6G 2R3
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Catherine B Chan, PhD University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01625507     History of Changes
Other Study ID Numbers: RES0013109
Study First Received: June 19, 2012
Results First Received: November 18, 2014
Last Updated: August 9, 2015
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 27, 2015