The Alberta Diet: Effectiveness Study

NCT01625507 | Completed Phase 2 Results

• 1 other identifier: RES0013109
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Change in Hemoglobin A1c

  4 months

• Program Retention

  3 months

• Change in Body Mass Index

  4 months

• Body Composition

  3 months

• Change in Blood Biomarkers

  4 months

Study Arms (1)

PANDA intervention

EXPERIMENTAL

12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.

Behavioral: PANDA intervention

Interventions

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

PANDA intervention

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes, and speak/write English.
• Have attended a diabetes education session delivered by their healthcare provider.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Catherine Chan
• Organization: University of Alberta

cbchan@ualberta.ca

780-492-9939

Study Officials

• Catherine B Chan, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 6, 2017
• Results First Posted: August 18, 2015

Record last verified: 2016-12

Locations

CA (1)