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Completed

NCT Number: NCT01625507

The Alberta Diet: Effectiveness Study

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PANDA intervention

Behavioral

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

Primary outcomes

  1. Change in Total Energy Intake

    Time frame: 4 months

    Measured using repeated 24 hour dietary recalls (pre and post-intervention)

  2. Change in Macronutrient Intake

    Time frame: 3 months

    Measured using repeated 24 hour dietary recalls (pre and post-intervention)

  3. Change in Nutrient Intake

    Time frame: 3 months

    Measured using repeated 24 hour dietary recalls (pre and post-intervention)

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 4 months

    a surrogate of blood glucose control

  2. Program Retention

    Time frame: 3 months

    attendance at meetings

  3. Change in Body Mass Index

    Time frame: 4 months

    Actual weight and height used to calculate BMI pre- and post-intervention

  4. Body Composition

    Time frame: 3 months

    body fat and fat-free mass

  5. Change in Blood Biomarkers

    Time frame: 4 months

    blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol

  6. Change in Perceived Dietary Adherence Questionnaire Score

    Time frame: 4 months

    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.

  7. Food Acceptability

    Time frame: 4 months

    questionnaire based on items related to personal and cultural acceptability of the recommended diet

  8. Food Accessibility

    Time frame: 4 months

    questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes

  9. Food Availability

    Time frame: 4 months

    questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.

  10. Change in Waist Circumference

    Time frame: 4 months

    Measured using repeated 24 hour dietary recalls (pre and post-intervention

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

The Alberta Diet: a Proposal for Its Implementation

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2012
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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