Trial Outcomes & Findings for The Alberta Diet: Effectiveness Study (NCT NCT01625507)
NCT ID: NCT01625507
Last Updated: 2017-02-06
Results Overview
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
COMPLETED
PHASE2
73 participants
4 months
2017-02-06
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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73
|
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Overall Study
COMPLETED
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63
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Alberta Diet: Effectiveness Study
Baseline characteristics by cohort
| Measure |
PANDA Intervention
n=73 Participants
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
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|---|---|
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Age, Continuous
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59.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
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Gender
Female
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34 Participants
n=5 Participants
|
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Gender
Male
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39 Participants
n=5 Participants
|
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Region of Enrollment
Canada
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73 participants
n=5 Participants
|
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Education
Less than high school
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5 participants
n=5 Participants
|
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Education
High school completed
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28 participants
n=5 Participants
|
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Education
College or university degree
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40 participants
n=5 Participants
|
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Employment
Wages and salaries
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41 participants
n=5 Participants
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Employment
Self-employment
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5 participants
n=5 Participants
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Employment
Retired
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18 participants
n=5 Participants
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Employment
Unemployed
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2 participants
n=5 Participants
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Employment
Other
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 4 monthsPopulation: All participants, intention to treat protocol
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Total Energy Intake
|
-178 kcal
Interval -305.0 to -51.0
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PRIMARY outcome
Timeframe: 3 monthsMeasured using repeated 24 hour dietary recalls (pre and post-intervention)
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Macronutrient Intake
Total fat
|
-1 percentage of total energy
Interval -3.0 to 0.0
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Change in Macronutrient Intake
Saturated fat
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0 percentage of total energy
Interval -1.0 to 0.0
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Change in Macronutrient Intake
Protein
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0 percentage of total energy
Interval 0.0 to 1.0
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Change in Macronutrient Intake
Carbohydrate
|
2 percentage of total energy
Interval 0.0 to 4.0
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Change in Macronutrient Intake
Added sugar
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0 percentage of total energy
Interval -1.0 to 1.0
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PRIMARY outcome
Timeframe: 3 monthsMeasured using repeated 24 hour dietary recalls (pre and post-intervention)
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Nutrient Intake
Total fat
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-10 grams
Interval -18.0 to -3.0
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Change in Nutrient Intake
Saturated fat
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-3 grams
Interval -6.0 to -1.0
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Change in Nutrient Intake
Monounsaturated fat
|
-3 grams
Interval -6.0 to 0.0
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Change in Nutrient Intake
Polyunsaturated fat
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0 grams
Interval -2.0 to 2.0
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Change in Nutrient Intake
Protein
|
-6 grams
Interval -11.0 to 0.0
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Change in Nutrient Intake
Carbohydrate
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-12 grams
Interval -28.0 to 4.0
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Change in Nutrient Intake
Fiber
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0 grams
Interval -1.0 to 1.0
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Change in Nutrient Intake
Total sugar
|
-5 grams
Interval -13.0 to 2.0
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Change in Nutrient Intake
Added sugar
|
-9 grams
Interval -17.0 to 0.0
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Change in Nutrient Intake
Cholesterol
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-.003 grams
Interval -0.045 to 0.05
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Change in Nutrient Intake
Sodium
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-.572 grams
Interval -0.869 to -0.275
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SECONDARY outcome
Timeframe: 4 monthsa surrogate of blood glucose control
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Hemoglobin A1c
|
-0.7 percentage of hemoglobin A1c
Interval -1.0 to -0.4
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SECONDARY outcome
Timeframe: 3 monthsattendance at meetings
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
|
|---|---|
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Program Retention
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63 Participants
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SECONDARY outcome
Timeframe: 4 monthsActual weight and height used to calculate BMI pre- and post-intervention
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Body Mass Index
|
-0.6 kg/m2
Interval -0.8 to -0.4
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SECONDARY outcome
Timeframe: 3 monthsbody fat and fat-free mass
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Body Composition
Change in Fat mass %
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-0.8 percentage change from baseline
Interval -1.5 to 0.0
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Body Composition
Change in Fat free mass %
|
0.8 percentage change from baseline
Interval 0.1 to 1.6
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SECONDARY outcome
Timeframe: 4 monthsblood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Blood Biomarkers
Triglycerides
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-10.4 mg/dL
Interval -23.1 to 2.2
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Change in Blood Biomarkers
Total cholesterol
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-63.5 mg/dL
Interval -80.1 to -46.9
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Change in Blood Biomarkers
High density lipoprotein cholesterol
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27.5 mg/dL
Interval 20.2 to 34.8
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Change in Blood Biomarkers
Low density lipoprotein cholesterol
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-88.9 mg/dL
Interval -105.3 to -72.5
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SECONDARY outcome
Timeframe: 4 monthsQuestionnaire 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.
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
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|---|---|
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Change in Perceived Dietary Adherence Questionnaire Score
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9.3 units on a scale
Interval 5.4 to 12.9
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SECONDARY outcome
Timeframe: 4 monthsquestionnaire based on items related to personal and cultural acceptability of the recommended diet
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsquestionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsquestionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsMeasured using repeated 24 hour dietary recalls (pre and post-intervention
Outcome measures
| Measure |
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
|
|---|---|
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Change in Waist Circumference
|
-2.4 cm
Interval -3.0 to -1.8
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Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place