Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
BEHAVIORALPANDA 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
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Energy Intake | 4 months | Measured using repeated 24 hour dietary recalls (pre and post-intervention) |
| Change in Macronutrient Intake | 3 months | Measured using repeated 24 hour dietary recalls (pre and post-intervention) |
| Change in Nutrient Intake | 3 months | Measured using repeated 24 hour dietary recalls (pre and post-intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 3 months | body fat and fat-free mass |
| Change in Blood Biomarkers | 4 months | blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol |
| Change in Perceived Dietary Adherence Questionnaire Score | 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. |
| Change in Hemoglobin A1c | 4 months | a surrogate of blood glucose control |
| Food Accessibility | 4 months | questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes |
| Food Availability | 4 months | questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes. |
| Change in Waist Circumference | 4 months | Measured using repeated 24 hour dietary recalls (pre and post-intervention |
| Food Acceptability | 4 months | questionnaire based on items related to personal and cultural acceptability of the recommended diet |
| Program Retention | 3 months | attendance at meetings |
| Change in Body Mass Index | 4 months | Actual weight and height used to calculate BMI pre- and post-intervention |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | PANDA Intervention |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 9.7 |
| Education College or university degree | 40 participants |
| Education High school completed | 28 participants |
| Education Less than high school | 5 participants |
| Employment Other | 7 participants |
| Employment Retired | 18 participants |
| Employment Self-employment | 5 participants |
| Employment Unemployed | 2 participants |
| Employment Wages and salaries | 41 participants |
| Gender Female | 34 Participants |
| Gender Male | 39 Participants |
| Region of Enrollment Canada | 73 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Macronutrient Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Change in Macronutrient Intake | Total fat | -1 percentage of total energy |
| All Participants | Change in Macronutrient Intake | Saturated fat | 0 percentage of total energy |
| All Participants | Change in Macronutrient Intake | Protein | 0 percentage of total energy |
| All Participants | Change in Macronutrient Intake | Carbohydrate | 2 percentage of total energy |
| All Participants | Change in Macronutrient Intake | Added sugar | 0 percentage of total energy |
Primary
Change in Nutrient Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Change in Nutrient Intake | Total fat | -10 grams |
| All Participants | Change in Nutrient Intake | Saturated fat | -3 grams |
| All Participants | Change in Nutrient Intake | Monounsaturated fat | -3 grams |
| All Participants | Change in Nutrient Intake | Polyunsaturated fat | 0 grams |
| All Participants | Change in Nutrient Intake | Protein | -6 grams |
| All Participants | Change in Nutrient Intake | Carbohydrate | -12 grams |
| All Participants | Change in Nutrient Intake | Fiber | 0 grams |
| All Participants | Change in Nutrient Intake | Total sugar | -5 grams |
| All Participants | Change in Nutrient Intake | Added sugar | -9 grams |
| All Participants | Change in Nutrient Intake | Cholesterol | -.003 grams |
| All Participants | Change in Nutrient Intake | Sodium | -.572 grams |
Primary
Change in Total Energy Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Time frame: 4 months
Population: All participants, intention to treat protocol
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Change in Total Energy Intake | -178 kcal |
Secondary
Body Composition
body fat and fat-free mass
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Body Composition | Change in Fat mass % | -0.8 percentage change from baseline |
| All Participants | Body Composition | Change in Fat free mass % | 0.8 percentage change from baseline |
Secondary
Change in Blood Biomarkers
blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol
Time frame: 4 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Change in Blood Biomarkers | Total cholesterol | -63.5 mg/dL |
| All Participants | Change in Blood Biomarkers | High density lipoprotein cholesterol | 27.5 mg/dL |
| All Participants | Change in Blood Biomarkers | Low density lipoprotein cholesterol | -88.9 mg/dL |
| All Participants | Change in Blood Biomarkers | Triglycerides | -10.4 mg/dL |
Secondary
Change in Body Mass Index
Actual weight and height used to calculate BMI pre- and post-intervention
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Change in Body Mass Index | -0.6 kg/m2 |
Secondary
Change in Hemoglobin A1c
a surrogate of blood glucose control
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Change in Hemoglobin A1c | -0.7 percentage of hemoglobin A1c |
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Change in Perceived Dietary Adherence Questionnaire Score | 9.3 units on a scale |
Secondary
Change in Waist Circumference
Measured using repeated 24 hour dietary recalls (pre and post-intervention
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Change in Waist Circumference | -2.4 cm |
Secondary
Food Acceptability
questionnaire based on items related to personal and cultural acceptability of the recommended diet
Time frame: 4 months
Secondary
Food Accessibility
questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes
Time frame: 4 months
Secondary
Food Availability
questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.
Time frame: 4 months
Secondary
Program Retention
attendance at meetings
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Program Retention | 63 Participants |