The Alberta Diet: Effectiveness Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of Alberta.
Recruitment status was  Recruiting
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
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

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014