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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PANDA intervention | Experimental | 12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | a surrogate of blood glucose control | 4 months |
| Program Retention | attendance at meetings | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine B Chan, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Diabetes Institute | Edmonton | Alberta | T6G 2R3 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | PANDA Intervention | 12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits. PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PANDA Intervention | 12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Energy Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | All participants, intention to treat protocol | Posted | Mean | 95% Confidence Interval | kcal | 4 months |
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | T2D diabetes patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Chan | University of Alberta | 780-492-9939 | cbchan@ualberta.ca |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| years |
|
| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Number | participants |
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| Employment | Number | participants |
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| Primary | Change in Macronutrient Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | Posted | Mean | 95% Confidence Interval | percentage of total energy | 3 months |
|
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| Primary | Change in Nutrient Intake | Measured using repeated 24 hour dietary recalls (pre and post-intervention) | Posted | Mean | 95% Confidence Interval | grams | 3 months |
|
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| Secondary | Change in Hemoglobin A1c | a surrogate of blood glucose control | Posted | Mean | 95% Confidence Interval | percentage of hemoglobin A1c | 4 months |
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| Secondary | Program Retention | attendance at meetings | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Change in Body Mass Index | Actual weight and height used to calculate BMI pre- and post-intervention | Posted | Mean | 95% Confidence Interval | kg/m2 | 4 months |
|
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| Secondary | Body Composition | body fat and fat-free mass | Posted | Mean | 95% Confidence Interval | percentage change from baseline | 3 months |
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| Secondary | Change in Blood Biomarkers | blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol | Posted | Mean | 95% Confidence Interval | mg/dL | 4 months |
|
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 months |
|
|
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| Secondary | Food Acceptability | questionnaire based on items related to personal and cultural acceptability of the recommended diet | Not Posted | 4 months | Participants |
| Secondary | Food Accessibility | questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes | Not Posted | 4 months | Participants |
| Secondary | Food Availability | questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes. | Not Posted | 4 months | Participants |
| Secondary | Change in Waist Circumference | Measured using repeated 24 hour dietary recalls (pre and post-intervention | Posted | Mean | 95% Confidence Interval | cm | 4 months |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |