Phase 2
N=73
The Alberta Diet: Effectiveness Study
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01625507 ↗Enrolled (actual)
73
Serious AEs
—
Results posted
Aug 2015
Primary outcome: Primary: Change in Total Energy Intake — -178 kcal
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PANDA intervention (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Energy Intake |
-178 | — |
| PRIMARY Change in Macronutrient Intake |
-1; 0; 0; 2; 0 | — |
| PRIMARY Change in Nutrient Intake |
-10; -3; -3; 0; -6; -12 | — |
| SECONDARY Change in Hemoglobin A1c |
-0.7 | — |
| SECONDARY Program Retention |
63 | — |
| SECONDARY Change in Body Mass Index |
-0.6 | — |
| SECONDARY Body Composition |
-0.8; 0.8 | — |
| SECONDARY Change in Blood Biomarkers |
-63.5; 27.5; -88.9; -10.4 | — |
| SECONDARY Change in Perceived Dietary Adherence Questionnaire Score |
9.3 | — |
| SECONDARY Food Acceptability |
— | — |
| SECONDARY Food Accessibility |
— | — |
| SECONDARY Food Availability |
— | — |
| SECONDARY Change in Waist Circumference |
-2.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01625507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.