The Alberta Diet: Effectiveness Study

This study is currently recruiting participants.
Verified October 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01625507
First received: June 19, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The study hypothesis is that individuals with type 2 diabetes, 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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


Secondary Outcome Measures:
  • 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

  • body mass index [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    actual weight and height

  • body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    waist circumference, body fat and fat-free mass

  • blood biomarkers [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    blood lipids

  • perceived adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire

  • food acceptability [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire

  • food accessibility [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire

  • food availability [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questionnaire


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PANDA 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

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

Contacts
Contact: Catherine B Chan, PhD 789-492-9939 cbchan@ualberta.ca
Contact: Rhonda C Bell, PhD 780-492-7742 rhonda.bell@ualberta.ca

Locations
Canada, Alberta
Alberta Diabetes Institute Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Ghada Asaad, M.Sc.    780-492-9964      
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
Last Updated: October 31, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014