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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

4 months

Results posted on

2017-02-06

Participant Flow

Participant milestones

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
Overall Study
STARTED
73
Overall Study
COMPLETED
63
Overall Study
NOT COMPLETED
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Alberta Diet: Effectiveness Study

Baseline characteristics by cohort

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
Age, Continuous
59.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
Gender
Female
34 Participants
n=5 Participants
Gender
Male
39 Participants
n=5 Participants
Region of Enrollment
Canada
73 participants
n=5 Participants
Education
Less than high school
5 participants
n=5 Participants
Education
High school completed
28 participants
n=5 Participants
Education
College or university degree
40 participants
n=5 Participants
Employment
Wages and salaries
41 participants
n=5 Participants
Employment
Self-employment
5 participants
n=5 Participants
Employment
Retired
18 participants
n=5 Participants
Employment
Unemployed
2 participants
n=5 Participants
Employment
Other
7 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: All participants, intention to treat protocol

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Total Energy Intake
-178 kcal
Interval -305.0 to -51.0

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Macronutrient Intake
Total fat
-1 percentage of total energy
Interval -3.0 to 0.0
Change in Macronutrient Intake
Saturated fat
0 percentage of total energy
Interval -1.0 to 0.0
Change in Macronutrient Intake
Protein
0 percentage of total energy
Interval 0.0 to 1.0
Change in Macronutrient Intake
Carbohydrate
2 percentage of total energy
Interval 0.0 to 4.0
Change in Macronutrient Intake
Added sugar
0 percentage of total energy
Interval -1.0 to 1.0

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Nutrient Intake
Total fat
-10 grams
Interval -18.0 to -3.0
Change in Nutrient Intake
Saturated fat
-3 grams
Interval -6.0 to -1.0
Change in Nutrient Intake
Monounsaturated fat
-3 grams
Interval -6.0 to 0.0
Change in Nutrient Intake
Polyunsaturated fat
0 grams
Interval -2.0 to 2.0
Change in Nutrient Intake
Protein
-6 grams
Interval -11.0 to 0.0
Change in Nutrient Intake
Carbohydrate
-12 grams
Interval -28.0 to 4.0
Change in Nutrient Intake
Fiber
0 grams
Interval -1.0 to 1.0
Change in Nutrient Intake
Total sugar
-5 grams
Interval -13.0 to 2.0
Change in Nutrient Intake
Added sugar
-9 grams
Interval -17.0 to 0.0
Change in Nutrient Intake
Cholesterol
-.003 grams
Interval -0.045 to 0.05
Change in Nutrient Intake
Sodium
-.572 grams
Interval -0.869 to -0.275

SECONDARY outcome

Timeframe: 4 months

a surrogate of blood glucose control

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Hemoglobin A1c
-0.7 percentage of hemoglobin A1c
Interval -1.0 to -0.4

SECONDARY outcome

Timeframe: 3 months

attendance at meetings

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Program Retention
63 Participants

SECONDARY outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Body Mass Index
-0.6 kg/m2
Interval -0.8 to -0.4

SECONDARY outcome

Timeframe: 3 months

body fat and fat-free mass

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Body Composition
Change in Fat mass %
-0.8 percentage change from baseline
Interval -1.5 to 0.0
Body Composition
Change in Fat free mass %
0.8 percentage change from baseline
Interval 0.1 to 1.6

SECONDARY outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Blood Biomarkers
Triglycerides
-10.4 mg/dL
Interval -23.1 to 2.2
Change in Blood Biomarkers
Total cholesterol
-63.5 mg/dL
Interval -80.1 to -46.9
Change in Blood Biomarkers
High density lipoprotein cholesterol
27.5 mg/dL
Interval 20.2 to 34.8
Change in Blood Biomarkers
Low density lipoprotein cholesterol
-88.9 mg/dL
Interval -105.3 to -72.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Perceived Dietary Adherence Questionnaire Score
9.3 units on a scale
Interval 5.4 to 12.9

SECONDARY outcome

Timeframe: 4 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

questionnaire 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 months

questionnaire 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 months

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

Outcome measures

Outcome measures
Measure
All Participants
n=73 Participants
T2D patients comparing post- to pre-intervention
Change in Waist Circumference
-2.4 cm
Interval -3.0 to -1.8

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Catherine Chan

University of Alberta

Phone: 780-492-9939

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place